en expedium verse spine...

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EXPEDIUM® VERSE Spine SystemIMPORTANT NOTE TO OPERATING SURGEONEXPEDIUM® VERSE spinal implants, like any other temporary internal fixation devices, have a finite useful life. The patient’s activity level has a significant impact on this useful life. Your patient must be informed that any activity increases the risk of loosening, bending, or breaking of the implant components. It is essential to instruct patients about restrictions to their activities in the postoperative period and to examine patients postoperatively to evaluate the development of the fusion mass and the status of the implant components. Even if solid bone fusion occurs, implant components may nevertheless bend, break, or loosen. Therefore, the patient must be made aware that implant components may bend, break, or loosen even though restrictions in activity are followed.

Because of the limitations imposed by anatomic considerations and modern surgical materials, metallic implants cannot be made to last indefinitely. Their purpose is to provide temporary internal support while the fusion mass is consolidating. These types of implants are more likely to fail if no bone graft is used, if a pseudarthrosis develops, or if patients have severe or multiple preoperative curves.

The surgeon may remove these implants after bone fusion occurs. The possibility of a second surgical procedure must be discussed with the patient, and the risks associated with a second surgical procedure must also be discussed. If the implants do break, the decision to remove them must be made by the physician who must consider the condition of the patient and the risks associated with the presence of the broken implant.

DESCRIPTIONDePuy Spine implants are NOT compatible with implants from other manufacturers unless otherwise specified.

Implants from each of the DePuy Spine systems are NOT interchangeable with implants from other DePuy Spine systems unless otherwise specified. Implants designed to interface with a specific rod diameter are NOT compatible with other rod diameters unless otherwise specified. Implants designed to interface with a

specific rod diameter are compatible with rods from other systems having the same diameter and same material per the table below.

Dual diameter rod components can have a combination of rod diameters corresponding to the existing straight rod diameters from each of the Spine Systems listed in the table below. These dual diameter rods can be used to connect rod constructs formed from the Original System to rod constructs from the Secondary System per the table below.

ORIGINAL SYSTEM SECONDARY SYSTEM(S)

EXPEDIUM VERSE Connects ToEXPEDIUM/VIPER/VIPER2, ISOLA/TIMX, MONARCH, MOSS MIAMI

Implants made of different materials are NOT compatible unless otherwise specified. The table below specifies implant material compatibility.

MATERIAL COMPATIBLE WITHStainless Steel alloys Stainless Steel alloys

Titanium alloys

Titanium alloys, Cobalt-Chromium-Molybdenum, Cobalt-Nickel-Chromium-Molybdenum, PEEK, Commercially Pure Titanium

Cobalt-Chromium-Molybdenum

Titanium alloys, Cobalt-Nickel-Chromium-Molybdenum

Cobalt-Nickel-Chromium-Molybdenum

Titanium alloys, Cobalt-Chromium-Molybdenum

Commercially Pure Titanium Titanium alloys

A subset of EXPEDIUM VERSE components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging from 4.5 to 6.35), hooks, screws, bolts, and connecting components. Similarly to the EXPEDIUM VERSE implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

2 of 14This document is valid only on the date printed. If unsure of the print date, please re-print to ensure use of the latest revision of the IFU (available at www.e-ifu.com). The onus resides with the user to ensure that the most up-to-date IFU is used.

DePuy Spine prepares Surgical Technique Manuals showing the use of the implants and instruments for each Spine System. Contact your DePuy Spine sales representative to obtain copies of these Surgical Technique Manuals.

EXPEDIUM VERSE Spine SystemThe EXPEDIUM VERSE Spine System consists of longitudinal rods, monoaxial screws, polyaxial screws, uni-planar screws, reduction screws, cable/wire screws, bolts, slotted connectors, wires, hooks, reduction hooks, transverse connectors, SFX Cross Connector System, dual rod connectors, sacral extenders, lateral connectors, and washers.

The EXPEDIUM VERSE Spine System is compatible with other systems through the use of single or dual rod connectors, lateral connectors, sacral extenders and dual diameter rods as follows:

• ISOLA Spine System rods • VIPER/VIPER2 System rods • MONARCH Spine System rods • MOSS MIAMI Spine System rods • TIMX Low Back System rods • Synthes SYNAPSE System rods

The cable/wire screw is intended to be used with stainless steel ISOLA Beaded Sublaminar Wire, manufactured by DePuy Spine, Inc., or with the stainless steel Single Cable with Crimp and Bar and the Single ISOLA Cable with Eyelet Leader components of the Songer Spinal Cable System, manufactured by Pioneer Surgical Technologies and distributed by DePuy Spine, Inc.

The EXPEDIUM VERSE Spine System components are available in commercially pure titanium or titanium alloy conforming to ASTM F-67, ASTM F-136 or ASTM F-1472 specifications, stainless steel conforming to ASTM F-138, ASTM F-1314, or F-2229 specifications, cobalt-nickel-chromium-molybdenum alloy wire conforming to ASTM F-562 specifications, as well as longitudinal rods in cobalt-chromium-molybdenum alloy conforming to ASTM F-1537 specifications.

Cobalt-chromium-molybdenum alloy rods and cobalt-nickel-chromium-molybdenum alloy wires are intended for use with titanium components only.

Ring nut and set screw assemblies are only intended for use with polyaxial, uni-planar, and monoaxial single innie (SI) pedicle screws and pedicle hooks within the EXPEDIUM 4.5mm and 5.5mm stainless steel and titanium Systems.

The extension tabs on the reduction screw and hook components are intended to be removed intraoperatively.

INDICATIONSThe EXPEDIUM VERSE Spine Systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM VERSE Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used in a posterior percutaneous approach with MIS instrumentation, the EXPEDIUM VERSE System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the EXPEDIUM VERSE System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The EXPEDIUM VERSE systems are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

CLEANING AND STERILIZATIONImplants and instruments of the EXPEDIUM VERSE Spine Systems may be provided either sterile or non-sterile and this will be clearly identified on the product labels.

Sterile ImplantsFor the implants supplied sterile, the contents are sterile unless the package is damaged, opened, or the expiration date on the device label has passed. The integrity of the packaging should be checked to ensure that the sterility of the contents is not compromised. Remove implants from packaging, using aseptic technique, only after the correct size has been determined.

PRECAUTION: Do not use implants if the condition of the package and/or labeling indicates a chance that the devices may not be sterile.

Implants supplied sterilized from the manufacturer must not be resterilized.


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Non-Sterile ImplantsFor the implants supplied non-sterile, they will be supplied clean. ISO 8828 or AORN recommended practices for in-hospital sterilization should be followed for all components.

Cleaning InstructionsFor EXPEDIUM Spine System:

ScopeDePuy Synthes EXPEDIUM VERSE Spine System

WARNINGS • Follow the instructions and warnings issued by the suppliers of any cleaning and equipment used.

• Do not exceed 140°C (284°F) during reprocessing steps. • Avoid exposure to hypochlorite solutions, as these will promote corrosion.

• Highly alkaline conditions (pH > 11) can damage products with aluminum parts

• Manual Cleaning must be performed prior to Automated Cleaning for all devices with lumens.

Limitations on Reprocessing • Repeated processing has minimal effects on instrument life and function.

• End of useful life is generally determined by wear or damage in surgical use.

• Carefully inspect instruments between uses to verify proper functioning.

• Send damaged instruments to a supplier of authorized repair or refurbishment services.

Decontamination Considerations – Creutzfeldt-Jakob Disease (CJD)

• Under certain classifications of risk, the World Health Organization (WHO), or local regulatory authorities recommend special CJD inactivation processing procedures. Consult WHO and local regulations for further information.

Care at the Point of Use • Clean instruments as soon as possible after use. If cleaning must be delayed, immerse instruments in a compatible detergent solution, spray with an instrument pre-soak solution, or cover instruments with a towel moistened with purified water to prevent drying and encrustation of surgical soil.

• Avoid prolonged exposure to saline to minimize the chance of corrosion.

• Remove excessive soil with a disposable wipe.

Containment and Transportation • Reprocess instruments as soon as is reasonably possible after use.

• Place the device in its respective position within the instrument tray.

• The image of the device is marked in its intended position within the tray

Preparation for CleaningFor multi-piece or complex instruments, please reference their disassembly instructions. Disassembly instructions are available per request by contacting DePuy Spine Customer Service (800-227-6633).

In the event that the instructions below cannot be completed as directed, please contact Customer Service to have the instruments returned for processing.

Manual CleaningAll Instruments and Implants:

• Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions.

• Soak soiled devices for a minimum recommended time specified by the enzymatic cleaning solution manufacturer or 5 minutes, whichever is longer.

• Use a soft bristle scrub brush (plastic bristles, like nylon) to remove all traces of blood and debris from the device surfaces.

EXPEDIUM Cannulated Taps: • EXPEDIUM Cannulated Taps have a 2 mm diameter cannulation. • Use a minimum 12 inch (305mm) long, 3 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device.

• Push the brush through the entire length of the lumen using a twisting motion to remove debris at least five times from both ends.

• Use a 50 ml syringe filled to capacity with enzymatic cleaning solution to flush the lumen of each device.

EXPEDIUM Alignment Guides: • EXPEDIUM Alignment Guides have an 11–12 mm diameter lumen.

• Use a minimum 12 inch (305 mm) long, 13 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device.



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EXPEDIUM Modular Handles: • EXPEDIUM Modular Handles have a 4–6.35 mm diameter hole. • Use a minimum 7 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the hole of each device.

Ratcheting Adapter (286710490): • The Ratcheting Adapter has a 2.4 mm diameter lumen. • Use a minimum 3 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen of each device.



• Scrub the exterior surface of the device while actuating the ratchet mechanism.

EXPEDIUM Quick Connect Screwdriver: • Actuate the driver while scrubbing the surface of the device by pulling the inner shaft and turning the outer sleeve at least three full rotations.

• Use a 50 ml syringe filled to capacity with enzymatic cleaning solution to flush the handle cavity.

• Repeat the flushing of the handle cavity through two different openings.

EXPEDIUM Devices with Lumens: • Use a minimum 12 inch (305 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device. Minimum brush diameters are specified in the table below for each lumen size. A toothbrush style brush, or equivalent, can be used for large lumen (>15 mm) devices:

Device Description

Product Code

Lumen Size

Brush Diameter

SAI COUNTER TORQUE 279704055 12 14MMSI DRIVER SLEEVE 279712200 10 14DRIVER SLEEVE FOR SI SCREWS 279712250 9 12

SI REDUCTION TUBE 279712460 9 –14 15MMSI ROD STABILIZER 279712500 12 13APPROXIMATOR FC SLEEVE 279712580 9 10APPX FC ROTATION TUBE 279712599 11 12LATERAL APPROXIMATOR 279712660 11 12FACILITATOR 279712888 11 12EXP 5.5 ANTITORQUE 279712920 12 13

Device Description

Product Code

Lumen Size

Brush Diameter

DI DRIVER SLEEVE 279722250 11 12XPDM DI REDUCTION TUBE 279722460 10 11DI ROD STABILIZER 279722500 12 13EXP DI FAR SCREWDRIVER SLEEVE 279722850 11 12

EXP DI FACILITATOR 279722888 12 13MIS ALIGNMENT DEVICE 279726400 2 7OPEN ALIGNMENT DEVICE 279726401 2 7IEXP CLOSED BOLT DRIVER 279729440 8 10EXP CLOSED BLT DRIVER COLLET 279729445 5 6

IEXP NUT INSERTER 279729450 5 10IEXP 8MM TIGHTENER L-HANDLE 279729470 8 9

IEXP SLOTTED CONN STABLIZER 279729610 7 8

IEXP CANN PLACEMENT WRENCH 279729640 7 8

EXP 635 MINI QUICK STICK 279734210 11 16DRIVER SLEEVE 279763250 11 12ROD STABILIZER 279763500 12 13APPROXIMATOR FLEX CLIP 279763570 11 15APPROXIMATOR FC SLEEVE 279763580 9 10APPROXIMATOR FC ROTATION TUBE 279763599 11 12

SI APPROXIMATOR SLEEVE 279763660 11 12DI APPROXIMATOR SLEEVE 279763670 11 12FACILITATOR 279763888 12 14EXP 6.35 ANTITORQUE 279763920 12 13VBD QUICK STICK 279788835 11 16VBD QUICK STICK OUTER SLEEVE 279788840 11 16

EXPEDIUM DEROTATION REDUCTION 279788870 16 17

EXP DEROT FLEX-CLIP INSERT 279788872 11 12

EXP DEROT FLEXCLIP INSERT 6.35 279788874 11 12

EXP DEROT QUICK STICK-SHORT 279788878 11 16

EXP5.5 DEROTATION QUICK STICK 279788935 11 16

EXP 5.5 DEROTATION QCK STICK F 279788955 11 16


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Device Description

Product Code

Lumen Size

Brush Diameter

CABLE/WIRE SCREWDRIVER 286210040 5 6ROD STABILIZER, SI 286210140 11 12ROD STABILIZER, SLOTTED CONN 286210230 11 12

FACILITATOR 286240085 9 10IN-LINE APPROXIMATOR PLUG 286240095 9 10

EXP 4.5 IN-LINE APPROX INSERTE 286240096 11 12

TUBE BENDERS 286260060 8 9SFX STABILIZER 289410400 7 9SFX CENTER ALIGN GUIDE 289410450 7 9EXP 4.5 SFX STABILIZER 289420400 8 9EXP ANT MONOAXIAL SCRW DRVR SLEEVE 287720105 9 10

EXP ANT CROSS CONN APPLICATOR 287730140 11 12

EXPEDIUM devices with holes or cavities: • Use a minimum 7 inch (175 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the holes of each device. Minimum brush diameters are specified in the table below for each hole size:

Device Description

Product Code

Hole Size

Brush Diameter

EXP OFFSET BOLT TUBE/PUSHER 279729480 6 & 3 mm 7 & 4 mm

IEXP BOLT CUTTER 279729910 7 8IEXP ROD CUTTER 279729930 5 8BOLT ALIGNMENT GUIDE 286210240 5 & 3 mm 6 & 4 mm

EXPEDIUM One Handed Rod Approximators: • Use a minimum 12 inch (305 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the lumen of each device. Minimum brush diameters are specified in the table below for each lumen size. A toothbrush style brush, or equivalent, can be used for large lumen (>15 mm) devices:

Device Description

Product Code

Lumen Size

Brush Diameter

ONE HANDED ROD APPROXIMATOR 279712510 11 12

ROD APPROX W/DOVETAIL 279712525 N/A N/A 6.35 ONE HANDED ROD APPROX 279712610 12 18

LATERAL APPROXIMATOR 279712650 10 15

Device Description

Product Code

Lumen Size

Brush Diameter

KERRISON STYLE REDUCT DEVICE 279763425 10 11

LATERAL APPROXIMATOR 279763650 10 15SQUEEZE HANDLE ROD APPROX 286240080 N/A N/A

IN-LINE APPROXIMATOR 286240090 11 15

• Actuate the Approximator while scrubbing the surface of the device by squeezing the handle at least three times.

• Use a 50 ml syringe filled to capacity with enzymatic cleaning solution to flush the spring and the mated surfaces between the inner and outer shafts.



All Instruments (cont.): • Rinse the instrument with warm, 85°F – 104°F (30°C - 40°C), tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone.

• Pay particular attention to flush the lumen of the dilators, ports, and suction tubes with warm, 85°F – 104°F (30°C - 40°C), tap water.

• Ultrasonically clean the device components for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions.

• Rinse the device components with warm, 85°F – 104°F (30°C - 40°C), tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone.

• Dry the device components immediately after final rinse with a clean towel or compressed air until visibly dry.

— OR —

Automated CleaningImplants

• Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions.

• Soak implants for a minimum recommended time specified by the enzymatic cleaning solution manufacturer or 5 minutes, whichever is longer. • Rinse the implants with warm, 85°F – 104°F (30°C - 40°C), tap water for a minimum of one minute (with agitation if contained within the caddy) and until visual evidence of cleaning solution is gone.


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• Ultrasonically clean the implants for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions.

• Continue processing with the All Instruments section.

All Instruments: • Prepare an enzymatic cleaning solution in accordance to the manufacturer’s instructions.

• Soak soiled instruments for a minimum recommended time specified by the enzymatic cleaning solution manufacturer or 5 minutes, whichever is longer.

• Use a soft bristle scrub brush (plastic bristles, like nylon) to remove all traces of blood and debris from the device surfaces.

EXPEDIUM Cannulated Taps: • EXPEDIUM Cannulated Taps have a 2 mm diameter cannulation. • Use a minimum 12 inch (305 mm) long, 3 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device.



EXPEDIUM Alignment Guides: • EXPEDIUM Alignment Guides have an 11– 12 mm diameter lumen.

• Use a minimum 12 inch (305mm) long, 13 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device.


• Use a 50ml syringe filled to capacity with enzymatic cleaning solution to flush the lumen of each device.

EXPEDIUM Modular Handles: • EXPEDIUM Modular Handles have a 4 – 6.35 mm diameter hole.

• Use a minimum 7 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the hole of each device.

Ratcheting Adapter (286710490): • The Ratcheting Adapter has a 2.4 mm diameter lumen. • Use a minimum 3 mm brush diameter, soft lumen brush (plastic bristles, like nylon) to scrub the lumen of each device.



• Scrub the exterior surface of the device while actuating the ratchet mechanism.

EXPEDIUM Quick Connect Screwdriver: • Actuate the driver while scrubbing the surface of the device by pulling the inner shaft and turning the outer sleeve at least three full rotations.

• Use a 50 ml syringe filled to capacity with enzymatic cleaning solution to flush the handle cavity.

• Repeat the flushing of the handle cavity through two different openings.

EXPEDIUM Devices with Lumens: • Use a minimum 12 inch (305 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the lumen or cannula of each device. Minimum brush diameters are specified in the table below for each lumen size. A toothbrush style brush, or equivalent, can be used for large lumen (>15 mm) devices:

Device Description

Product Code

Lumen Size

Brush Diameter

SAI COUNTER TORQUE 279704055 12 14MMSI DRIVER SLEEVE 279712200 10 14DRIVER SLEEVE FOR SI SCREWS 279712250 9 12

SI REDUCTION TUBE 279712460 9 –14 15MMSI ROD STABILIZER 279712500 12 13APPROXIMATOR FC SLEEVE 279712580 9 10APPX FC ROTATION TUBE 279712599 11 12LATERAL APPROXIMATOR 279712660 11 12FACILITATOR 279712888 11 12EXP 5.5 ANTITORQUE 279712920 12 13DI DRIVER SLEEVE 279722250 11 12XPDM DI REDUCTION TUBE 279722460 10 11DI ROD STABILIZER 279722500 12 13EXP DI FAR SCREWDRIVER SLEEVE 279722850 11 12

EXP DI FACILITATOR 279722888 12 13MIS ALIGNMENT DEVICE 279726400 2 7OPEN ALIGNMENT DEVICE 279726401 2 7IEXP CLOSED BOLT DRIVER 279729440 8 10EXP CLOSED BLT DRIVER COLLET 279729445 5 6

IEXP NUT INSERTER 279729450 5 10IEXP 8MM TIGHTENER L-HANDLE 279729470 8 9


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Device Description

Product Code

Lumen Size

Brush Diameter

IEXP SLOTTED CONN STABLIZER 279729610 7 8

IEXP CANN PLACEMENT WRENCH 279729640 7 8

EXP 635 MINI QUICK STICK 279734210 11 16DRIVER SLEEVE 279763250 11 12ROD STABILIZER 279763500 12 13APPROXIMATOR FLEX CLIP 279763570 11 15APPROXIMATOR FC SLEEVE 279763580 9 10APPROXIMATOR FC ROTATION TUBE 279763599 11 12

SI APPROXIMATOR SLEEVE 279763660 11 12DI APPROXIMATOR SLEEVE 279763670 11 12FACILITATOR 279763888 12 14EXP 6.35 ANTITORQUE 279763920 12 13VBD QUICK STICK 279788835 11 16VBD QUICK STICK OUTER SLEEVE 279788840 11 16

EXPEDIUM DEROTATION REDUCTION 279788870 16 17

EXP DEROT FLEX-CLIP INSERT 279788872 11 12

EXP DEROT FLEXCLIP INSERT 6.35 279788874 11 12

EXP DEROT QUICK STICK-SHORT 279788878 11 16

EXP5.5 DEROTATION QUICK STICK 279788935 11 16

EXP 5.5 DEROTATION QCK STICK F 279788955 11 16

CABLE/WIRE SCREWDRIVER 286210040 5 6ROD STABILIZER, SI 286210140 11 12ROD STABILIZER, SLOTTED CONN 286210230 11 12

FACILITATOR 286240085 9 10IN-LINE APPROXIMATOR PLUG 286240095 9 10

EXP 4.5 IN-LINE APPROX INSERTER 286240096 11 12

TUBE BENDERS 286260060 8 9SFX STABILIZER 289410400 7 9SFX CENTER ALIGN GUIDE 289410450 7 9EXP 4.5 SFX STABILIZER 289420400 8 9

Device Description

Product Code

Lumen Size

Brush Diameter

EXP ANT MONOAXIAL SCRW DRVR SLEEVE 287720105 9 10

EXP ANT CROSS CONN APPLICATOR 287730140 11 12



EXPEDIUM devices with holes or cavities: • Use a minimum 7 inch (175 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the holes of each device. Minimum brush diameters are specified in the table below for each hole size:

Device Description

Product Code

Hole Size

Brush Diameter

EXP OFFSET BOLT TUBE/PUSHER 279729480 6 & 3 mm 7 & 4 mm

IEXP BOLT CUTTER 279729910 7 8IEXP ROD CUTTER 279729930 5 8BOLT ALIGNMENT GUIDE 286210240 5 & 3 mm 6 & 4 mm

EXPEDIUM One Handed Rod Approximators: • Use a minimum 12 inch (305 mm) long, tight fitting, soft lumen brush (plastic bristles, like nylon) to scrub the lumen of each device. Minimum brush diameters are specified in the table below for each lumen size. A toothbrush style brush, or equivalent, can be used for large lumen (>15 mm) devices:

Device Description

Product Code

Lumen Size

Brush Diameter

ONE HANDED ROD APPROXIMATOR 279712510 11 12

ROD APPROX W/DOVETAIL 279712525 N/A N/A6.35 ONE HANDED ROD APPROX 279712610 12 18

LATERAL APPROXIMATOR 279712650 10 15KERRISON STYLE REDUCT DEVICE 279763425 10 11

LATERAL APPROXIMATOR 279763650 10 15SQUEEZE HANDLE ROD APPROX 286240080 N/A N/A

IN-LINE APPROXIMATOR 286240090 11 15

All Instruments (cont.): • Rinse the instrument with warm, 85°F – 104°F (30°C - 40°C), tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone.

• Pay particular attention to flush the lumen of the dilators, ports, and suction tubes with warm, 85°F – 104°F (30°C - 40°C), tap water.

• Ultrasonically clean the device components for 10 minutes in neutral pH detergent, prepared in accordance with the manufacturer’s instructions.

• Rinse the device components with warm, 85°F – 104°F (30°C - 40°C), tap water for a minimum of one minute and until visual evidence of debris, soil, and cleaning solution are gone.

• Load the device components so that the lumens of the ports, dilators, and suction tubes can drain.

• Clean, using the “INSTRUMENTS” cycle in a validated washer disinfector and a pH neutral cleaning agent intended for use in automated cleaning using the minimum cycle parameters below:

Phase

Recirculation Time

Water Temp

Detergent Type

Pre-Wash 2:00 Cold Tap Water N/A

Enzyme Wash 1:00 Hot Tap Water Enzymatic Cleaner

Wash 2:00 65.5°C Neutral pH DetergentRinse 0:15 Hot Tap Water N/ADry 15:00 66°C N/A

Cleaning Inspection • Inspect all devices before sterilization or storage to ensure the complete removal of soil from surfaces, lumens, holes, and moveable parts.

• If areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in a 3% hydrogen peroxide solution. If bubbling is observed, blood is present. Rinse instru-ments for a minimum of 1 minute with warm, 85°F – 104°F (30°C - 40°C), tap water after using hydrogen peroxide solution.

• If soil is still present, re-clean the instrument.

DisinfectionDevices must be terminally sterilized prior to surgical use. See Sterilization instructions.

MaintenanceCarefully inspect instruments between uses to verify proper functioning. Send damaged instruments to a supplier of authorized repair or refurbishment services.

Inspection and Functional Testing • Visually inspect the instruments for damage and wear. • The shafts should be free of bending and distortion. • Cutting edges of the Drills should be free of nicks and have a continuous edge.

• Moveable parts should have smooth movement without excessive play.

• Locking mechanisms should fasten securely and close easily.

Packaging • If desired, use instrument trays to contain instruments that are provided in sets.

• Double wrap instruments in accordance with local procedures, using standard wrapping techniques such as those described in the current revision of ANSI/AAMI ST79.

Sterilization • Use a validated, properly maintained and calibrated steam sterilizer.

• Effective steam sterilization can be achieved using the following cycle:

Cycle Type

Temperature

Exposure Time

Dry Time

Pre-Vacuum 270°F (132°C) 4 minutes 60 minutesPre-Vacuum 273°F (134°C) 3 minutes 60 minutes

• Post-sterilization drying of the sterilization load within the sterilization vessel is standard practice in hospitals. ANSI/AAMI ST79:2006, “Comprehensive guide to steam sterilization and sterility assurance in health care facilities” provides guidance to hospitals for selecting appropriate drying parameters based on the sterilization cycle that is being conducted. Sterilizer manufacturers also typically provide recommendations for drying parameters for their specific equipment.

• Only legally marketed, FDA cleared sterilization wrap, pouches, or DePuy Synthes Reusable Sterilization Containers should be used by the end-user for packaging terminally sterilized devices. The manufacturer’s instructions for use for the steril-ization wrap, pouches, or DePuy Synthes Reusable Sterilization Containers are to be followed. The use of DePuy Synthes Reusable Sterilization Containers are limited to use in the United States only, and are not approved for use outside of the United States.

StorageStore sterile packaged devices in a manner that provides protection from dust, moisture, insects, vermin, and extremes of temperature and humidity.


MAGNETIC RESONANCE (MR) COMPATIBILITYThe EXPEDIUM VERSE Spine System has not been evaluated for safety and compatibility in the MR environment. They have not been tested for heating or migration in the MR environment.

USAGEWARNING: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.

CoCr tapered rods are not intended to connect the EXPEDIUM Spine System to the Synthes SYNAPSE System.

PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon must be thoroughly knowledgeable not only in the medical and surgical aspects of the implant, but must also be aware of the mechanical and metallurgical limitations of metallic surgical implants. Postoperative care is extremely important. The patient must be instructed in the limitations of the metallic implant and be warned regarding weight bearing and body stresses on the appliance prior to firm bone healing. The patient should be warned that noncompliance with postoperative instructions could lead to failure of the implant and possible need thereafter for additional surgery to remove the device.

Refer to the individual system surgical technique manuals for additional important information.

DePuy Spine Spinal System components should not be used with components from other manufacturers unless otherwise specified.

Stainless steel components may interfere with the quality of imaging obtained using MRI.

During the surgical procedure, the rods may be cut to size and shaped to provide correction and maintain proper anatomic lordotic and kyphotic alignment.

When using anterior thoracic/lumbar screw fixation systems, staples, staple washers and washers are available to optimize proper staple/screw/rod alignment and stability.

Screw diameters of 11 mm and 12 mm are indicated for use only in the sacrum or ilium. Pre-operative use of CT imaging to determine the appropriate screw diameter, length, insertion trajectory, and clearance is strongly recommended when large diameter screws are indicated.

After solid fusion occurs, these devices serve no functional pur-pose and may be removed. In some cases, removal is indicated because the implants are not intended to transfer or to support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient taking into consideration the patient’s general medical condition and the potential risk to the patient of a second surgical procedure.

These devices are not intended or expected to be the only mechanism for support of the spine. Regardless of the etiology of the spinal pathology, for which implantation of these devices was chosen, it is the expectation and requirement that a spinal fusion or arthrodesis be planned and obtained. Without solid biological support provided by spinal fusion, the devices cannot be expected to support the spine indefinitely and will fail in any of several modes. These modes may include bone-metal interface failure, implant fracture, or bone failure.

POSTOPERATIVE MOBILIZATIONUntil X-rays confirm the maturation of the fusion mass, external immobilization (such as bracing or casting) is recommended.

Instructions to the patient to reduce stress on the implants are an equally important part of the attempt to avoid the occurrence of clinical problems that may accompany fixation failure.

CONTRAINDICATIONSDisease conditions that have been shown to be safely and predictably managed without the use of internal fixation devices are relative contraindications to the use of these devices.

Active systemic infection or infection localized to the site of the proposed implantation are contraindications to implantation.

Severe osteoporosis is a relative contraindication because it may prevent adequate fixation of spinal anchors and thus preclude the use of this or any other spinal instrumentation system.

Any entity or condition that totally precludes the possibility of fusion, i.e., cancer, kidney dialysis, or osteopenia is a relative contraindication. Other relative contraindications include obesity, certain degenerative diseases, and foreign body sensitivity. In addition, the patient’s occupation or activity level or mental capacity may be relative contraindications to this surgery. Specifically, patients who because of their occupation or lifestyle, or because of conditions such as mental illness, alcoholism, or drug abuse, may place undue stresses on the implant during bony


healing and may be at higher risk for implant failure. See also the WARNINGS, PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICES section of this insert.

WARNINGS, PRECAUTIONS, AND POSSIBLE ADVERSE EFFECTS CONCERNING TEMPORARY METALLIC INTERNAL FIXATION DEVICESFollowing are specific warnings, precautions, and possible adverse effects that should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects that can occur with surgery in general, but are important considerations particular to metallic internal fixation devices. General surgical risks should be explained to the patient prior to surgery.

WARNINGS1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY

IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to with-stand indefinitely the unsupported stress of full weight bearing.

2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices which are used to obtain alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to metal fatigue. The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure.

3. MIXING METALS CAN CAUSE CORROSION. There are many forms of corrosion damage and several of these occur on metals surgically implanted in humans. General or uniform corrosion is present on all implanted metals and alloys. The rate of corrosive attack on metal implant devices is usually very low due to the presence of passive surface films. Dissimilar metals in contact, such as titanium and stainless steel, accelerate the corrosion process of stainless steel and more rapid attack occurs. The presence of corrosion often accelerates fatigue fracture of implants. The amount of metal

compounds released into the body system will also increase. Internal fixation devices, such as rods, hooks, etc., which come into contact with other metal objects, must be made from like or compatible metals.

4. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure:

A. The patient’s weight. An overweight or obese patient can produce loads on the device that can lead to failure of the appliance and the operation.

B. The patient’s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain, twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he /she should not return to these activities until the bone is fully healed. Even with full healing, the patient may not be able to return to these activities successfully.

C. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications.

D. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance. For such cases, orthopaedic devices can only be considered a delaying technique or temporary remedy.

E. Foreign body sensitivity. The surgeon is advised that no preoperative test can completely exclude the possibility of sensitivity or allergic reaction. Patients can develop sensitivity or allergy after implants have been in the body for a period of time.

F. Smoking. Patients who smoke have been observed to experience higher rates of pseudarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement.

G. The safety and effectiveness of these devices has not been established for use as part of a pediatric growing rod construct. These devices are only intended to be used when definitive fusion is being performed at all instrumented levels


H. The use of pedicle screw fixation in the pediatric population may present additional risks when patients are of smaller stature and skeletally immature. Pediatric patients may have smaller spinal structures (pedicle diameter or length) that may preclude the use of pedicle screws or increase the risk of pedicle screw malpositioning and neurological or vascular injury. Patients not skeletally mature that undergo spinal fusion procedures may have longitudinal spinal growth, or may be at risk for rotational spinal deformities (the “crankshaft phenomenon”) due to continued differential growth of the anterior spine.

Other adverse events related to pedicle screw fixation, such as screw or rod bending, breakage, or loosening, may also occur in pediatric patients. Pediatric patients may be at increased risk for device related injury because of their smaller stature.

PRECAUTIONS1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An

explanted metal implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. Reuse can compromise device performance and patient safety. Reuse of single use devices can also cause cross-contamination leading to patient infection.

2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Contouring of metal implants should only be done with proper equipment. The operating surgeon should avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure.

3. CONSIDERATIONS FOR REMOVAL OF THE IMPLANT AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain; (2) Migration of implant position resulting in injury; (3) Risk of additional injury from postoperative trauma; (4) Bending, loosening, and/or breakage, which could make removal imprac-tical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of the device; (6) Possible increased risk of infection; and (7) Bone loss due to stress shielding. The surgeon should carefully weigh the risks versus benefits when deciding whether to remove the implant. Implant removal should be followed by adequate postoperative management to avoid refracture. If the patient is older and has a low activity level, the surgeon may choose not to remove the implant thus eliminating the risks involved with a second surgery.

4. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient’s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implant, and instructed to limit and restrict physical activities, especially lifting and twisting motions and any type of sports participation. The patient should understand that a metallic implant is not as strong as normal healthy bone and could loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may migrate and damage the nerves or blood vessels. An active, debilitated, or demented patient who cannot properly use weight-supporting devices may be particularly at risk during postoperative rehabilitation.

5. CORRECT PLACEMENT OF ANTERIOR SPINAL IMPLANT. Due to the proximity of vascular and neurologic structures to the implantation site, there are risks of serious or fatal hemorrhage and risks of neurologic damage with the use of this product. Serious or fatal hemorrhage may occur if the great vessels are eroded or punctured during implantation or are subsequently damaged due to breakage of implants, migration of implants or if pulsatile erosion of the vessels occurs because of close apposition of the implants.

The implantation of pedicle screw spinal systems in pediatric patients should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system in pediatric patients because this is a technically demanding procedure presenting a risk of serious injury to the patient.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and placement of the implants are important considerations in the successful utilization of the system in pediatric patients.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, the important medical information given in this document should be conveyed to the patient.

POSSIBLE ADVERSE EFFECTS1. Bending or fracture of implant.

2. Loosening of the implant.

3. Metal sensitivity or allergic reaction to a foreign body.

4. Infection, early or late.

5. Nonunion, delayed union.

6. Decrease in bone density due to stress shielding.


7. Pain, discomfort, or abnormal sensations due to the presence of the device.

8. Nerve damage due to surgical trauma or presence of the device. Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, and paraesthesia.

9. Bursitis.

10. Paralysis.

11. Dural tears experienced during surgery could result in the need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis.

12. Death.

13. Vascular damage due to surgical trauma or presence of the device. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could erode these vessels and cause catastrophic bleeding in the late postoperative period.

14. Screw back out, possibly leading to implant loosening, and/or reoperation for device removal.

15. Damage to lymphatic vessels and/or lymphatic fluid exudation.

16. Spinal cord impingement or damage.

17. Fracture of bony structures.

18. Degenerative changes or instability in segments adjacent to fused vertebral levels.

Additional Adverse Events for Pediatric Patients1. Inability to use pedicle screw fixation due to anatomic

limitations (pedicle dimensions, distorted anatomy).2. Pedicle screw malpositioning, with our without neurological or

vascular injury.3. Proximal or distal junctional kyphosis.4. Pancreatitis.

LIMITED WARRANTY AND DISCLAIMERPRODUCTS FROM DEPUY SYNTHES PRODUCTS, LLC ARE SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS, ARE HEREBY DISCLAIMED.IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/REVISION OF THIS INSERT AND THE DATE OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE FOR CURRENT INFORMATION AT +1-800-365-6633 OR AT +1-508-880-8100.


MATERIAL MATL

SYMBOL TRANSLATION

A/T ACROFLEX®/Ti ACROFLEX®/Titanium

A AI Aluminum

A/P A l /PLAluminum/Plastic

B/R Ba/RADEL®Barium/RADEL®

Ba/PEEKBarium Sulfate (BaSO4)/

PEEK Polymer

CaP CALCIUM PHOSPHATE

Calcium Phosphate

CM CoCrMoCobalt Chromium

Molybdenum

CMTC CoCrMo/Ti /CALCIUM

PHOSPHATECobalt Chromium

Molybdenum/Titanium/Calcium Phosphate

CoNiCrMoCobalt Nickel

Chromium Molybdenum

F FOAMFoam

HA Hydroxyapatite

NiTi Ni /TiNickel /Titanium

PL Plastic

SRSI SS/RADEL®/SILICONE

Stainless Steel /RADEL®/Silicone

SRSN SS/RADEL®/

SILICONE/Ti Al NitrideStainless Steel /RADEL®/

Silicone/Titanium Aluminum Nitride

SS/RADEL®/SILICONE/Ti Nitride

Stainless Steel/RADEL®/Silicone/Titanium Nitride

SRTA SS/RADEL®/Ti Al NitrideStainless Steel /RADEL®/

Titanium Aluminum Nitride

STA SS/Ti Al NitrideStainless Steel /

Titanium Aluminum Nitride

S/U SS/ULTEMStainless Steel /Ultem

T TiTitanium and its alloys

S/R SS/RADEL®Stainless Steel /RADEL®

R/T POLYOLEFIN RUBBER/Ti

Polyolefin Rubber/Titanium

T/A Ti /AlTitanium/Aluminum

Ti /CoCrMoTitanium/Cobalt

Chromium Molybdenum

P/F PL/FOAMPlastic /Foam

PY Polyester

PEEK/C PEEK/CARBON

FIBER COMPOSITEPolyether Ether Ketone/Carbon Fiber Composite

PEEK OPTIMA®Polyether Ether Ketone

P POLYMERPolymer

P/CM PE/CoCrMoPolyethylene/Cobalt

Chromium Molybdenum

P/C POLYMER/CARBON FIBER COMPOSITE

Polymer/Carbon Fiber Composite

Si /NITINOLSilicone/Nitinol

S SSStainless Steel

S/A SS/AlStainless Steel /Aluminum

SBR SS/Ba/RADEL®Stainless Steel /Barium/

RADEL®

S/P SS/PHENOLICStainless Steel /Phenolic

S/PL SS/PLStainless Steel /Plastic

LOT LOT NUMBER

REF REFCATALOG NUMBER

QTY QUANTITY

SZ SIZE

MADE IN MADE IN

NTINEURAL TISSUE

INSTRUMENT

IOMNEUROMONITORING

INSTRUMENTS

Federal (USA) law restricts this device to sale by or on the order of a physician

DO NOT RESTERILIZE

T2

T1

Lower Limit of temperature = T1

Upper Limit of temperature = T2

25°C

STORE AT ROOM TEMPERATURE

KEEP AWAY FROM SUNLIGHT

SINGLE USE

ATTENTION. SEE INSTRUCTIONS

FOR USE

PACKAGE CONTAINS FLAMMABLE LIQUID

DO NOT USE IF PACKAGE IS

DAMAGED

MSRMEASURING DEVICE

STERILESTERILE

STERILE ASterile medical device

processed using aseptic technique

STERILE RSTERILIZATION BY

IRRADIATION

STERILE EOSTERILIZATION BY ETHYLENE OXIDE

LATEX FREELATEX FREE

NONSTERILE

NONSTERILENONSTERILE

MANUFACTURER

DATE OF MANUFACTURE

US REPUS REPRESENTATIVE

EC REPAUTHORIZED EUROPEAN

REPRESENTATIVE

DISTDISTRIBUTED BY

XXXX-XX

USE BY

Ti /HA Titanium/Hydroxyapatite

Ti /UHMWPE/HATitanium/Ultra-High

Molecular Weight Polyethylene/Hydroxyapatite

SS/TiStainless Steel /Titanium

SS/Al /SILICONEStainless Steel /

Aluminum/Silicone

SS/SILICA GLASSStainless Steel /Silica Glass

SS/SILICA GLASS/PL/SILICONE

Stainless Steel /Silica Glass/Plastic /Silicone

SS/SILICA GLASS/RADEL®/SILICONE

Stainless Steel /Silica Glass/RADEL®/Silicone

SS/SILICA GLASS/SILICONE

Stainless Steel /Silica Glass/Silicone

S/SI SS/SILICONEStainless Steel /Silicone

SS/WC/SILICONEStainless Steel /Tungsten

Carbide/Silicone

W/C Tungsten Carbide

Ti/CoCrMoTitanium / Cobalt Chromium Molybdenum


*

DePuy Spine, Inc. 325 Paramount Drive

Raynham, MA 02767-0350 USA

*

Medos International SÀRL Chemin-Blanc 38

2400 Le Locle, Switzerland

*For recognized manufacturer, refer to product label.

US REP

DePuy Spine, Inc. 325 Paramount Drive

Raynham, MA 02767-0350 USA Phone: +1 (800) 451 2006 FAX: +1 (508) 828 3700

EC REP

DePuy International, Ltd. St. Anthony’s Road

Leeds LS11 8DT England Phone: +44 113 270 0461 FAX: +44 113 272 4101

Issued November 2014 © DePuy Synthes Spine, a division of DOI 2013-2014.

All rights reserved.


00860902-90-128 Rev. A

bg

Спинална система EXPEDIUM® VERSEВАЖНА ЗАБЕЛЕЖКА ЗА ОПЕРИРАЩИЯ ХИРУРГСпиналните импланти EXPEDIUM® VERSE, подобно на всички други изделия за временна вътрешна фиксация, имат ограничен полезен живот. Нивото на активност на пациента има значи телно влияние върху този полезен живот. Вашият пациент трябва да бъде информиран, че всяка активност повишава риска от разхлабване, огъване или счупване на компонентите на импланта. От съществено значение е пациентите да се инструктират за ограниченията на тяхната активност в постоперативния период и да се изследват посто-перативно за оценяване на развитието на фузионната маса и на състоянието на компонентите на импланта. Дори ако настъпи солидна костна фузия, компонентите на импланта могат все пак да се огънат, счупят или да се разхлабят. Затова пациентът трябва да бъде уведомен, че компонентите на импланта могат да се огънат, счупят или да се разхлабят, дори ако се спазват ограниченията в активността.Поради ограниченията, наложени от анатомични съображения и от модерните хирургични материали, металните импланти не могат да бъдат направени така, че да траят неопределено дълго. Тяхното предназначение е да осигуряват временна вътрешна опора, докато фузионната маса се консолидира. По-вероятно е тези видове импланти да не функционират добре, ако не се използва костен графт, ако се развие псевдоартроза или ако пациентите имат тежки или множествени изкривявания преди операцията.Хирургът може да отстрани тези импланти след настъпване на костна фузия. Възможността за втора хирургична процедура трябва да се обсъди с пациента, също трябва да се обсъдят рисковете, свързани с втора хирургична процедура. Ако имплантите се счупят, решението за отстраняването им трябва да се вземе от лекаря, който трябва да прецени състоянието на пациента и рисковете, свързани с присъствието на счупения имплант.

ОПИСАНИЕИмплантите на DePuy Spine НЕ са съвместими с импланти от други производители, освен ако не е указано друго. Имплантите от всяка от системите на DePuy Spine НЕ са взаимно заменяеми с импланти от други системи на DePuy Spine, освен ако не е указано друго. Имплантите, предвидени за интерфейс с пръчки с конкретен диаметър НЕ са съвмес-тими с пръчки с друг диаметър, освен ако не е указано друго. Импланти, предвидени за интерфейс с пръчки с конкретен диаметър са съвместими с пръчки от други системи, които имат същия диаметър и са от същия материал в съответствие с таблицата по-долу.Пръчките с два диаметъра могат да имат комбинация от диа-метри на пръчките, съответстващи на наличните диаметри на прави пръчки от всяка от спиналните системи, изброени в таблицата по-долу. Тези пръчки с два диаметъра могат да се използват за свързване на конструкции от пръчки, образувани от оригиналната система, към конструкции от пръчки от вторичната система в съответствие с таблицата по-долу.

ОРИГИНАЛНА СИСТЕМА ВТОРИЧНА СИСТЕМА(И)

EXPEDIUM VERSEСвързва се към

EXPEDIUM/VIPER/VIPER2, ISOLA/TIMX, MONARCH, MOSS MIAMI

Имплантите, произведени от различни материали, НЕ са съвместими, освен ако не е указано друго. В таблицата по-долу е посочена съвместимостта на материалите на имплантите.МАТЕРИАЛ СЪВМЕСТИМ ССплави с неръждаема стомана Сплави с неръждаема стомана

Титаниеви сплавиТитаниеви сплави, кобалт-хром-молибден, кобалт-никел-хром-молибден, PEEK, търговски чист титан

Кобалт-хром-молибден

Титаниеви сплави, кобалт-никел-хром-молибден

1 of 16Този документ е валиден само към отпечатаната дата. Ако не сте сигурни каква е тази дата, моля, отпечатайте отново, за да сте сигурни, че използвате последното издание на инструкциите за употреба. (Наличен на www.e-ifu.com). Задължението за използване на най-актуалните инструкции за употреба е на потребителя.

2 of 16

МАТЕРИАЛ СЪВМЕСТИМ СКобалт-никел-хром-молибден

Титаниеви сплави, кобалт-хром-молибден

Търговски чист титан Титаниеви сплави

Подгрупа от компоненти на EXPEDIUM VERSE може да се използва за задна педикуларна винтова фиксация при педиатрични случаи. Тези конструкции могат да се състоят от разнообразни по форма и размер пръчки (от 4,5 до 6,35), куки, винтове, болтове и свързващи компоненти. Подобно на използваните при възрастни импланти EXPEDIUM VERSE, тези компоненти могат да се заключват ригидно в разнообразни конфигурации, като всяка конструкция се създава персонализирано за конкретния случай.DePuy Spine подготвя ръководства за хирургична техника, показващи употребата на имплантите и инструментите за всяка спинална система. Свържете се с Вашия търговски представител на DePuy Spine, за да получите копия на тези ръководства за хирургична техника.

Спинална система EXPEDIUM VERSEСпиналната система EXPEDIUM VERSE се състои от лонгитудинални пръчки, моноаксиални винтове, полиаксиални винтове, монопланарни винтове, редукционни винтове, винтове за кабели/телове, болтове, конектори със слотове, телове, куки, редукционни куки, трансверзални конектори, система с кръстосани конектори SFX, конектори от двойни пръчки, сакрални удължители, латерални конектори и шайби. Спиналната система EXPEDIUM VERSE е съвместима с други системи посредством използването на конектори с една или с две пръчки, латерални конектори, сакрални удължители и пръчки с два диаметъра, както следва:

• Пръчки на спиналната система ISOLA • Пръчки на системата VIPER/VIPER2 • Пръчки на спиналната система MONARCH • Пръчки на спиналната система MOSS MIAMI • Пръчки на системата за долна част на гръбнака TIMX • Пръчки на системата Synthes SYNAPSE

Винтът за кабели/телове е предназначен за употреба със субламинарната зърнеста тел от неръждаема стомана ISOLA, произведена от DePuy Spine, Inc., или с единичния кабел от неръждаема стомана с гънка и пръчка и с единичния кабел с водач с отвор ISOLA на спиналната кабелна система Songer, произведена от Pioneer Surgical Technologies и разпространявана от DePuy Spine, Inc.Компонентите на спиналната система EXPEDIUM VERSE се предлагат във варианти от търговски чист титан или

титаниева сплав, отговаряща на спецификациите на ASTM F-67, ASTM F-136 или ASTM F-1472, неръждаема стомана, отговаряща на спецификациите на ASTM F-138, ASTM F-1314 или F-2229, тел от кобалт-никел-хром-молибденова сплав, отговаряща на спецификациите на ASTM F-562, както и лонгитудинални пръчки от кобалт-хром-молибденова сплав, отговаряща на спецификациите на ASTM F-1537. Пръчките от кобалт-хром-молибденова сплав и пръчките от кобалт-никел-хром-молибденова сплав са предвидени за употреба само с титаниеви компоненти. Комплектите от пръстеновидни гайки и заключващи винтове са предвидени за употреба само с полиаксиални, монопланарни и моноаксиални с една вътрешна част (SI) педикуларни винтове и педикуларни куки в рамките на 4,5 mm и 5,5 mm системи EXPEDIUM от неръждаема стомана и титан. Удължаващите крила на редукционните винтове и куки са предвидени да се отстраняват интраоперативно.

ПОКАЗАНИЯСпиналните системи EXPEDIUM VERSE са предназначени за осигуряване на имобилизация и стабилизация на гръбначните сегменти при пациенти със завършен костен растеж като спомагателно средство към фузията при лечение на остра и хронична нестабилност или деформитети на торакалния, лумбалния и сакралния сегмент на гръбнака.Спиналната система EXPEDIUM VERSE е предназначена за педикуларна фиксация извън цервикалния сегмент на гръбнака и непедикуларна фиксация при следните показания: дегенеративно заболяване на дисковете (дефинирано като болка в гърба от дискогенен произход с дегенерация на диска, потвърдена от анамнезата и рентгенографски изследвания); спондилолистеза; травма (т.е. фрактура или дислокация); спинална стеноза, изкривявания (т.е. сколиоза, кифоза и/или лордоза); тумор, псевдоартроза; и неуспешна предходна фузия при пациенти със завършен костен растеж.Когато се използва със заден перкутанен достъп с инстру-менти за MIS, системата EXPEDIUM VERSE е предназначена за педикуларна фиксация извън цервикалния сегмент на гръбнака и непедикуларна фиксация при следните показа-ния: дегенеративно заболяване на дисковете (дефинирано като болка в гърба от дискогенен произход с дегенерация на диска, потвърдена от анамнезата и рентгенографски изследвания); спондилолистеза; травма (т.е. фрактура или дислокация); спинална стеноза, изкривявания (т.е. сколиоза, кифоза и/или лордоза); тумор, псевдоартроза; и неуспешна предходна фузия при пациенти със завършен костен растеж.

Този документ е валиден само към отпечатаната дата. Ако не сте сигурни каква е тази дата, моля, отпечатайте отново, за да сте сигурни, че използвате последното издание на инструкциите за употреба. (Наличен на www.e-ifu.com). Задължението за използване на най-актуалните инструкции за употреба е на потребителя.

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Когато се използват за задна педикуларна винтова фиксация извън цервикалния сегмент на гръбнака при педиатрични пациенти, металните импланти на системата EXPEDIUM VERSE са показани като спомагателно средство за фузия при лечение на идиопатична сколиоза при подрастващи. Системите EXPEDIUM VERSE са предназначени за употреба с автографт и/или алографт. Педикуларната винтова фиксация е ограничена за заден достъп.

ПОЧИСТВАНЕ И СТЕРИЛИЗИРАНЕИмплантите и инструментите на спиналните системи EXPEDIUM VERSE могат да се предоставят стерилни или нестерилни и това ще бъде ясно обозначено на етикетите на продуктите.

Стерилни имплантиЗа имплантите, които се предоставят стерилни, съдържанието е стерилно, ако опаковката не е повредена, отворена или срокът на годност на етикета на изделието не е изтекъл. Целостта на опаковката трябва да се провери, за да се гарантира, че стерилността на съдържанието не е нарушена. Извадете имплантите от опаковката, като използвате асептична техника, едва след определяне на правилния размер. ПРЕДПАЗНИ МЕРКИ: Не използвайте импланти, ако състоянието на опаковката и/или етикета показва, че има вероятност изделията да не са стерилни.Имплантите, които се предоставят стерилизирани от производителя, не трябва да се стерилизират повторно.

Нестерилни имплантиИмплантите, които се предоставят нестерилни, ще се предоставят чисти. За всички компоненти трябва да се следват препоръчваните от ISO 8828 или AORN процедури за стерилизация в болницата.

ИНСТРУКЦИИ ЗА ПОЧИСТВАНЕЗа спинална система EXPEDIUM: ОбсегСпинална система EXPEDIUM VERSE на DePuy Synthes

ПРЕДУПРЕЖДЕНИЯ • Следвайте указанията и предупрежденията, издадени от производителите на използваните почистващи средства и оборудване. • Не превишавайте 140°C (284°F) по време на стъпките на повторна обработка.

• Избягвайте излагане на разтвори на хипохлорит, тъй като те могат да причинят корозия. • Силно алкални условия (pH > 11) могат да повредят продуктите с алуминиеви части. • Преди автоматизирано почистване трябва да се извърши ръчно почистване за всички изделия с лумени.

Ограничения за повторна обработка • Повторната обработка има минимален ефект върху живота и функцията на инструмента. • Краят на полезния живот по принцип се определя от износването или повреждането при хирургична употреба. • Оглеждайте внимателно инструментите преди отделните им използвания, за да се уверите в правилното им функциониране. • Изпращайте повредените инструменти на доставчик за оторизирана поправка или сервизен ремонт.

Съображения във връзка с обеззаразяване – Болест на Creutzfeldt-Jakob (Cjd)

• При определени класификации на риска Световната здравна организация (СЗО) или местните регулаторни власти препоръчват специални процедури за обработка за инактивиране на CJD. За допълнителна информация направете справка с разпоредбите на СЗО и местните разпоредби.

Грижа на мястото на употреба • Почиствайте инструментите колкото е възможно по-скоро след употребата им. Ако почистването трябва да се отложи, потопете инструментите в разтвор на съвместим детергент, напръскайте ги с разтвор за предварително накисване на инструменти, или покрийте инструментите с кърпа, навлажнена с пречистена вода, за да предотвратите засъхването и образуването на люспи от хирургични замърсявания. • Избягвайте продължителното излагане на физиологичен разтвор, за да намалите възможността за корозия. • Отстранете излишните замърсявания с кърпа за еднократна употреба.

Съхранение и транспортиране • Обработвайте повторно инструментите колкото е разумно възможно по-скоро след употреба. • Поставете изделието в съответното му положение в таблата за инструменти. • Изображението на изделието е обозначено на предвиденото място в таблата.


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Подготовка за почистванеЗа многокомпонентни или сложни инструменти, моля, направете справка с указанията им за разглобяване. Указания за разглобяване могат да бъдат получени при поискване от отдела за обслужване на клиенти на DePuy Spine на (800 227-6633).В случай, че указанията по-долу не могат да се изпълнят според посоченото, моля, свържете се с отдела за обслужване на клиенти за връщане на инструментите за обработка.

Ръчно почистванеВсички инструменти и импланти:

• Пригответе ензимен почистващ разтвор в съответствие с инструкциите на производителя. • Накиснете замърсените изделия най-малко за препоръчителното време, посочено от производителя на ензимния почистващ разтвор или за 5 минути, което е по-дълго. • Използвайте четка за изтъркване с меки влакна (с пластмасови влакна, например найлон), за да отстраните всички следи от кръв и остатъци от повърхностите на изделието.

Канюлирани винторези EXPEDIUM: • Канюлираните винторези EXPEDIUM имат канюлация с диаметър 2 mm. • Използвайте мека четка за лумен с дължина най-малко 305 mm (12 инча) и диаметър 3 mm (с пластмасови влакна, например найлон) за изтъркване на лумена или канюлата на всяко изделие. • Прокарайте четката по цялата дължина на лумена с въртеливо движение за отстраняване на остатъците, най-малко пет пъти от двата края. • Използвайте спринцовка от 50 ml, напълнена до крайния обем с ензимен почистващ разтвор, за да промиете лумена на всяко изделие.

Водачи за подравняване EXPEDIUM: • Водачите за подравняване EXPEDIUM имат лумен с диаметър 11–12 mm. • Използвайте мека четка за лумен с дължина най-малко 305 mm (12 инча) и диаметър 13 mm (с пластмасови влакна, например найлон) за изтъркване на лумена или канюлата на всяко изделие. • Прокарайте четката по цялата дължина на лумена с въртеливо движение за отстраняване на остатъците, най-малко пет пъти от двата края.

• Използвайте спринцовка от 50 ml, напълнена до крайния обем с ензимен почистващ разтвор, за да промиете лумена на всяко изделие.

Модулни дръжки EXPEDIUM: • Модулните дръжки EXPEDIUM имат отвор с диаметър 4 – 6,35 mm. • Използвайте мека четка за лумен с диаметър най-малко 7 mm (с пластмасови влакна, например найлон) за изтъркване на отвора на всяко изделие.

Адаптор със зъбен механизъм (286710490): • Адапторът със зъбен механизъм има лумен с диаметър 2,4 mm. • Използвайте мека четка за лумен с диаметър най-малко 3 mm (с пластмасови влакна, например найлон) за изтъркване на лумена на всяко изделие. • Прокарайте четката по цялата дължина на лумена с въртеливо движение за отстраняване на остатъците, най-малко пет пъти от двата края. • Използвайте спринцовка от 50 ml, напълнена до крайния обем с ензимен почистващ разтвор, за да промиете лумена на всяко изделие. • Изтрийте външната повърхност на изделието, докато задвижвате зъбния механизъм.

Винтоверт за бързо свързване EXPEDIUM: • Задействайте винтоверта, докато изтривате повърхността на изделието, като издърпате вътрешната ос и завъртите външния ръкав най-малко на три пълни оборота. • Използвайте спринцовка от 50 ml, напълнена до крайния обем с ензимен почистващ разтвор, за да промиете кухината на дръжката. • Повторете промиването на кухината на дръжката през два различни отвора.

Изделия с лумени EXPEDIUM: • Използвайте мека четка за лумен с дължина най-малко 305 mm (12 инча) и плътно прилягане (с пластмасови влакна, например найлон) за изтъркване на лумена или канюлата на всяко изделие. Минималните диаметри на четката са посочени в таблицата по-долу за всеки размер на лумен. Четка тип „четка за зъби“ или подобна на нея може да се използва за изделия с широк лумен (> 15 mm):

Описание на изделието

Код на издели-

ето

Раз-мер на лумена

Диаме-тър на четката

SAI ИЗДЕЛИЕ ЗА ОБРАТНО УСУКВАНЕ 279704055 12 14

MMSI РЪКАВ НА ВИНТОВЕРТ 279712200 10 14


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ето


Диаме-тър на четката

РЪКАВ НА ВИНТОВЕРТ ЗА SI ВИНТОВЕ 279712250 9 12

SI РЕДУКЦИОННА ТРЪБА 279712460 9 -14 15MMSI СТАБИЛИЗАТОР ЗА ПРЪЧКИ 279712500 12 13

FC РЪКАВ ЗА АПРОКСИМАТОР 279712580 9 10APPX FC РОТАЦИОННА ТРЪБА 279712599 11 12

ЛАТЕРАЛЕН АПРОКСИМАТОР 279712660 11 12ФАСИЛИТАТОР 279712888 11 12EXP 5.5 ИЗДЕЛИЕ ЗА АНТИ-УСУКВАНЕ 279712920 12 13

DI РЪКАВ НА ВИНТОВЕРТ 279722250 11 12XPDM DI РЕДУКЦИОННА ТРЪБА 279722460 10 11

DI СТАБИЛИЗАТОР ЗА ПРЪЧКИ 279722500 12 13

EXP DI ДАЛЕЧЕН РЪКАВ НА ВИНТОВЕРТ 279722850 11 12

EXP DI ФАСИЛИТАТОР 279722888 12 13MIS ИЗДЕЛИЕ ЗА ПОДРАВНЯВАНЕ 279726400 2 7

ИЗДЕЛИЕ ЗА ОТКРИТО ПОДРАВНЯВАНЕ 279726401 2 7

IEXP ЗАТВОРЕН ВИНТОВЕРТ ЗА БОЛТОВЕ 279729440 8 10

EXP ПАТРОННИК ЗА ЗАТВОРЕН ВИНТОВЕРТ ЗА БОЛТОВЕ

279729445 5 6

IEXP ПРИСПОСОБЛЕНИЕ ЗА ВЪВЕЖДАНЕ НА ГАЙКИ 279729450 5 10

IEXP 8 MM L-ОБРАЗНА ДРЪЖКА НА ИЗДЕЛИЕ ЗА ЗАТЯГАНЕ

279729470 8 9

IEXP СТАБИЛИЗАТОР ЗА КОНЕКТОРИ СЪС СЛОТОВЕ 279729610 7 8

IEXP ГАЕЧЕН КЛЮЧ ЗА ПОСТАВЯНЕ НА КАНЮЛИ 279729640 7 8

EXP 635 МИНИ ИЗДЕЛИЕ ЗА БЪРЗО ЗАЛЕПВАНЕ 279734210 11 16

РЪКАВ НА ВИНТОВЕРТ 279763250 11 12СТАБИЛИЗАТОР ЗА ПРЪЧКИ 279763500 12 13ГЪВКАВ КЛИПС ЗА АПРОКСИМАТОР 279763570 11 15



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