orion anterior st

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as described by:

Gary L. Lowery, M.D., Ph.D.

ORION

Anterior Cervical Plate SystemSurgical Technique


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Preliminary Steps

Position the head in a stable supine position (head rest or traction) with

slight extension of the neck. Confirm positioning and vertebral levels to bevisualized via fluoroscopy. Traction on the arms is often helpful.

A standard transverse incision can be made for one or two level corpectomies.It is important to dissect the fascial planes fully for longer constructs.Occasionally a carotid incision is necessary for difficult exposures and longreconstructions.

Perform corpectomy or prepare interbody fusion receptor sites.

Obtain cervical lordosis and/or distraction, if necessary.

Prepare trapezoidal strut construct or trapezoidal interbody fusion wedge(s).

Carefully position and impact strut or interbody fusion construct(s).

Release distraction (promoting compression) and check stability of construct.

Again, ensure levels to be instrumented can be easily identified onfluoroscopy.

Ensure all anterior osteophytes are removed for proper plate positioning.

Surgical Technique

ORION

Anterior Cervical Plate System

As described by Gary L. Lowery, MD, PhD

1


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Surgical Technique

STEP 1

Determine appropriate plate length: Position the plate screwholes close to the graft receptor site at both cranial and caudal ends(figure 1A). This allows for the 15 cephalad and caudad screwangulation (figure 1B) and helps ensure that the plate does notextend over the adjacent disc spaces (ORION Anterior Cervical

Plate x-ray templates are available for referencing plate length andpositioning).

2


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1515

Convergent Plate

Bone Graft andPlate Position1 A

Cephalad/CaudadScrew Angulation1 B

3


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4

Surgical Technique

STEP 2

Adjust lordotic curvature of plate if necessary: The amount oflordosis designed into the ORION Anterior Cervical Plate isacceptable in a majority of cases. If required, changes can be made tothe standard machined lordotic curve by using the ORION PlateBender (figure 2A). A gentle bend should be made over the entire

length of the plate and sharp angulations must be avoided. It isimportant to note that plate contouring will alter the standardcranial and caudal angulation of the end screws (figure 2B).


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The Standard Cranial andCaudal Angulation of Screws2 B

Changing thePlate Contour2 A

FRONT VIEW WITHORION PLATE BENDER

THE ORIONPLATE BENDER

BENDING POINT

15 15

5


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6

Surgical Technique

STEP 3

Secure the ORION Anterior Cervical Plate to the Plate Holder: ThePlate Holder (figure 3A) will lock within any of the central slots on thevarious plates. The smallest plates do not have diagonal central slots. Akocher, bayonet, sucker tip, etc. will suffice for holding these smallersize plates.

To attach the Plate Holder to the plate, slide the sleeve toward thehandle and engage the feet into the plates diagonal slot. Slide thesleeve down toward the plate to lock the holder to the plate (figure 3B). I


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Plate HolderLocked Into Plate3 B

The Plate Holder3 A

SLEEVE(open position)

FEET

SLEEVE(closedposition)

Feet engage intodiagonal slots inplate

7


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8

Surgical Technique

STEP 4

Position the ORION Plate on the anterior surface of the spine:Review landmarks to ensure the plate is centered medially/laterallyon the spine (figure 4A). The uncinate processes serve as excellentreference points.


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Plate

Plate Holder(sleeve in locked position)

Positioning the PlateMedially/Laterally4 A

9


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10

Surgical Technique

STEP 5

Insert the Drill Guide: Seat the Drill Guide into the plate at thecorrect cranial/caudal and convergent angle (figure 5A). ForConvergent Plate constructs, the Drill Guide angles 6 toward themidline of the plate.

Once the Drill Guide is correctly seated into the plate, the Drill Guidecan then be securely locked into the plate by applying lightdownward pressure on the Drill Guide handle, making sure to alignthe handle along the longitudinal axis of the plate (figure 5B).


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5 B

Lightdow

nwardpre

ssure,

"locks"Dr

illGuidein

toplate

LONGITU

DINALA

XIS

LATERALAXIS

Locking The DrillGuide Into Plate

SIDEVIEW:END OF PLATE

END VIEW:CONVERGENT PLATE

PlateDrill Guide

15 6

Angulation of Drill Guide inCranial/Caudal Direction5 A

LightPressureappliedatDrill

Guidehandleappliesforceto

"lock"DrillGuideintoposition

Plate

Drill Guide

SIDEVIEW:END OF PLATE

11


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Surgical Technique

STEP 6

Drill holes for taps/screws: Insert the appropriate Drill Bit into theDrill Guide. Drill the screw holes using either the 13 mm Drill Bit(figure 6A) or the Adjustable Drill Bit and Adjustable Drill Stop (figure6B). Screw length is determined by the depth of bone purchaserequired (figure 6C).

For standard unicortical screw purchase, the 13 mm Drill Bit is used.For screws other than 13 mm in length, the Adjustable Drill Bit (10-26 mm depth) and Adjustable Drill Stop are used (figure 6B). Ifrequired, controlled penetration of the posterior cortex may beachieved by setting the Adjustable Drill Stop at the appropriatedepth. The Adjustable Drill Stop provides for 1 mm increments andan additional safety factor during the drilling procedure, in additionto fluoroscopic visualization.


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13

Drill Guide and13mm Drill Bit6 A

Drill Guide with Adjustable DrillBit and Adjustable Drill Stop6 B

13mmSCREW

13mm screw size results in13mm of bone purchase

Adjustable Drill Bitadjusts from 10mmto 26mm depth

in one millimeterincrements

DeterminingBone Screw Length6 C

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14

Surgical Technique

STEP 7

Tap the vertebral bodies: Remove the Drill Guide, insert theappropriate Tap into the predrilled hole at the same angulation, and tapthe vertebral bodies using the Tap which corresponds to the Drill Bitlength determined in Step 6. Taps are available in the sameconfiguration as the Drill Bits, i.e. 13 mm Screw Tap (figure 7A) and

Adjustable Screw Tap and Adjustable Tap Stop for 10-26 mm (figure 7B).


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13mm Screw Tap7 A Adjustable Screw Tap andAdjustable Tap Stop7 B

Adjustable Screw Tapadjusts from 10mmto 26mm depth inone millimeterincrements

15


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Surgical Technique

STEP 8

Implant screws: If required, a Depth Gauge may be used to confirmdepth of hole for proper screw length. The Depth Gauge workseither through the plate (figure 8A) or against the bone (figure 8B)and is accurate for both unicortical and bicortical techniques.

The appropriate length screw can be verified using the Screw/PlateGauge (figure 8C).

Insert the appropriate length screw through the plate, using theScrewdriver with tapered, self-holding tip and tighten screwsecurely (not final tightening) (figure 8D).

Note: The preferred method of screw insertion is as follows:

1. Drill, tap and place one screw securely through the plate (ifconcerns requiring mediolateral tilt or positioning arise,obtain an AP radiograph prior to drilling the screw hole).

2. Then, drill, tap and place one screw securely at the oppositeend of the plate, diagonally from the first screw position.

3. The remaining two screw implant sites are then drilled andtapped with the screws securely inserted.


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Depth GaugeThrough Plate8 A

Depth GaugeOn Bone8 B

VerifyingScrew Length

8 C

ScrewInsertion8 D

SCREWGAUGE

15

15

17


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Surgical Technique

STEP 9

Final tightening of bone screws: Normally, the Plate Holder is notrequired after the first one or two screws have been implanted. Ifrequired, though, it can be used throughout the entire procedureand can also be easily repositioned during implantation.

Tighten the screws to ensure they are seated below the surface of theplate (figure 9A). Obtain radiographs to ensure that screw lengthand screw position are appropriate. Although plate malpositionmay be determined from a lateral radiograph (i.e. screws notaligned in the same plane,) an AP radiograph provides additionalinformation regarding verification of implant position.

Screws can now be placed in the diagonal slot (figure 9B) if

deemed necessary (i.e. multi-level interbody fusions or long strutgraft reconstructions).

It is recommended that the gold colored 4.35 mm diameter screwsare used (11, 13 or 15 mm lengths) in the diagonal slots. The DrillGuide is positioned in the center slot of the plate and the hole isdrilled to either an 11, 13 or 15 mm depth. These holes should bedrilled in a straight manner into the bone as shown (figure 9B). Thegold colored 4.35 mm Tap and Adjustable Tap Stop are then used

to tap the hole to the appropriate depth. The 4.35 mm screws arethen inserted using the screwdriver and firmly tightened.


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Final Tightening ofBone Screws9 A

Placing Screw inDiagonal Slot9 B

Bone screwsfully seated into plate

19


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Surgical Technique

STEP 10

Insert the locking screws: Attach the Lock Screw Holder to theLock Screw by gently squeezing the prongs, then engage theHolder into the Lock Screw (figure 10A). Slide the sleeve downtoward the end of he holder. After the Lock Screw is initiallythreaded into the plate (figure 10B), detach the Lock Screw Holder

by pulling the sleeve up and tilting the holder to release from theLock Screw. (Note: Do not attempt to tighten the Lock Screw with theLock Screw Holder. Doing so will cause damage to the instrument.) Finaltightening of the Lock Screw is accomplished through the use ofthe Lock Screw Driver (figure 10C). One the Lock Screw Driver isfirmly placed into the slot, turn the Lock Screw clockwise until theScrew Driver slips out of the slot (this is a self-limiting device). TheLock Screw is now firmly secured.

Irrigate would and close would over a drain.


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The completed ORION Anterior Cervical Plate Construct

Attaching the Lock Screw Holderto the Lock Screw10 A

Initial Threading of theLock Screw Into Plate10 B

Final Tightening of the Lock Screwwith the Lock Screw Driver10 C

21


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Surgical Technique

Postoperative Protocol

Postoperative protocol varies with the surgeons personalpreference and training. The ORION ANTERIOR CERVICALPLATE SYSTEM provides secure selective vertebral immobilizationobviating, in certain cases, the need for external brace supportwhile allowing freedom of movement of the unaffected levels.External support (i.e. hard collar) while in a moving vehicle may

be beneficial for a time. Radiographic evaluation should beperformed at 2, 6, and 12 weeks and then on each of the extendedfollow-up visits (6 month, 12 month, etc.) Physical therapyusually consists of home exercises for range of motion andisometric strengthening.


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23

871-001 Lock Screw871-010 4.0 x 10 mm Cancellous Screw

871-011 4.0 x 11 mm Cancellous Screw




















8710121 21.5 mm Convergent Plate




8710130 30.0 mm Convergent Plate8710132 32.5 mm Convergent Plate




























Titanium Implants

Catalog # Description Catalog # Description

Catalog Listing


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24

870-500 Bone Screw Pick-up871-601 Drill Guide

871-602 DTS Guide

871-605 Lock Screw Holder

871-606 Adjustable Drill Bit, Tri-Flat (Sterile)

871-609 Adjustable Screw Tap

4.0 mm Cancellous

871-610 Screw Driver

871-611 Screw/Plate Gauge

871-612 Plate Bender

871-614 Adjustable Drill Stop

871-615 Lock Screw Driver

871-616 13 mm Drill Bit, Tri-Flat

871-617 13 mm Screw Tap

871-619 Adjustable Screw Tap

4.35 mm Cancellous

871-620 4.35 mm Screw Removal Instrument871-624 Adjustable Tap Stop

871-625 Depth Gauge

871-626 Adjustable Drill Bit, Circular (Sterile)

871-630 Drill Bit Handle

871-636 13 mm Drill Bit, Circular (Sterile)

871-640 Angled Lock Screw Holder

871-650 Plate Holder

871-651 Universal Plate Holder

871-655 Plate Holding Pin Driver

871-656 Plate Holding Pin

871-685 Plate Holding Pin Case

871-690 ORION Screw Lid

871-695 4.5 mm Screw Case

871-698 Convergent Sterilization Case

Instruments

Catalog # Description Catalog # Description

Catalog Listing

All instruments sold separately.


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Purpose:The ORION Anterior Cervical Plate System components are temporary implants that are intended for anterior interbodyscrew/plate fixation of the cervical spine during the development of a cervical spinal fusion.

Description:The ORION Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers arepre-assembled to the plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebralbody of the cervical spine using an anterior approach.

The ORION Anterior Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136or ISO 5832-3. This material is not compatible with other metal alloys. Stainless steel and titanium implant components shouldnot be used together in a construct. Sofamor Danek expressly warrants that these devices are fabricated from the foregoingmaterial specification. No other warranties, expressed or implied, are made. Implied warranties of merchantability and fitness fora particular purpose or use are specifically excluded. Do not use any of the ORION Anterior Cervical Plate System componentswith the components from any other system or manufacturer.

Indications,Contraindications, and Possible Adverse Effects.

Indications:Properly used, this system is intended for anterior interbody screw/plate fixation of the cervical spine. The indications and con-traindications of spinal instrumentation systems should be well-understood by the surgeon. The system is indicated for use in thetemporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerativedisc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history andradiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5)pseudarthrosis, and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING:This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine.

Contraindications:Contraindications include, but are not limited to:

1. Infection, local to the operative site.2. Signs of local inflammation.3. Fever or leukocytosis.4. Morbid obesity.5. Pregnancy.6. Mental illness.7. Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the elevation

of sedimentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBCdifferential count.

8. Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since thiscondition may limit the degree of obtainable correction, the amount of mechanical fixation, and/or the quality of the bonegraft.

9. Suspected or documented metal allergy or intolerance.10. Any case not needing a bone graft and fusion or where fracture healing is not required.11. Any case requiring the mixing of metals from different components.12. Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality,

or anatomical definition.

13. Any case not described in the Indications.14. Any patient unwilling to cooperate with the post-operative instructions.15. Any time implant utilization would interfere with anatomical structures or expected physiological performance.

Potential Adverse Events:All of the possible adverse events associated with spinal fusion surgery without instrumentation are possible.With instrumentation, a listing of possible adverse events includes, but is not limited to:

1. Early or late loosening of any or all of the components.2. Disassembly, bending, and/or breakage of any or all of the components.3. Foreign body (allergic) reaction to implants, debris, corrosion products, graft material, including metallosis, staining, tumor

formation, and/or auto-immune disease.4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, and/or pain. Bursitis. Tissue damage caused by improper positioning and placement of implants orinstruments.

5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.6. Infection.7. Dural tears.8. Loss of neurological function, including paralysis (complete or incomplete), dysesthesias, hyperesthesia, anesthesia,

paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, or tinglingsensation.

9. Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, and/or arachnoiditis.10. Loss of bowel and/or bladder control or other types of urological system compromise.11. Scar formation possibly causing neurological compromise around nerves and/or pain.12. Fracture, microfracture, resorption, damage, or penetration of any spinal bone and/or bone graft or bone graft harvest site at,

above, and/or below the level of surgery.13. Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.14. Non-union (or pseudarthrosis). Delayed union. Mal-union.15. Cessation of any potential growth of the operated portion of the spine.16. Loss of spinal mobility or function.17. Inability to perform the activities of daily living.18. Bone loss or decrease in bone density, possibly caused by stress shielding.

19. Graft donor site complications including pain, fracture, or wound healing problems.20. Atelectasis, ileus, gastritis, herniated nucleus pulposus, retropulsed graft.21. Hemorrhage, hematoma, seroma, embolism, edema, stroke, excessive bleeding, phlebitis, wound necrosis, wound

dehiscence, or damage to blood vessels.22. Gastrointestinal and/or reproductive system compromise, including sterility and loss of consortium.23. Development of respiratory problems, e.g. pulmonary embolism, bronchitis, pneumonia, etc.24. Change in mental status25. Death.

Note: Additional surgery may be necessary to correct some of these anticipated adverse events.

Warnings and Precautions:A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many ex-tenuating circumstances may compromise the results. The ORION Anterior Cervical Plate System is only a temporary implantused for the correction and stabilization of the spine. This system is also intended to be used to augment the development of aspinal fusion by providing temporary stabilization. This device system is not intended to be the sole means of spinal support.Bone grafting must be part of the spinal fusion procedure in which the ORION Anterior Cervical Plate System is utilized. Use ofthis product without a bone graft or in cases that develop into a non-union will not be successful. This spinal implant cannotwithstand body loads without the support of bone. In this event, bending, loosening, disassembly and/or breakage of the device(s)will eventually occur. Preoperative planning and operating procedures, including knowledge of surgical techniques, proper reduc-tion, and proper selection and placement of the implant are important considerations in the successful utilization of the ORIONAnterior Cervical Plate by the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results.Patients who smoke have been shown to have an increased incidence of non-unions. These patients should be advised of thisfact and warned of this consequence. Obese, malnourished, and/or alcohol and/or other drug abuse patients are also not goodcandidates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also not good candidates forspine fusion.

CAUTION:FOR USE ON OR BY THE ORDER OF A PHYSICIAN ONLY.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

Other preoperative, intraoperative, and postoperative warnings are as follows:

Preoperative:1. Only patients that meet the criteria described in the indications should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.3. Care should be used in the handling and storage of the implant components. The implants should not be scratched or other-

wise damaged. Implants and instruments should be protected during storage especially from corr osive environments.4. The type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate inventory

of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.5. Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment

and should personally assemble the devices to verify that all parts and necessary instruments are present before the surgerybegins. The ORION Anterior Cervical Plate System components are not to be combined with the components from anothermanufacturer. Different metal types should not be used together.

6. All components and instruments should be cleaned and sterilized before use. Additional sterile components should be avail-able in case of an unexpected need.

Intraoperative:1. Any instruction manuals should be carefully followed.2. At all times, extreme caution should be used around the spinal cord and nerve r oots. Damage to nerves will cause loss of

neurological functions.3. When the configuration of the bone cannot be fitted with an available temporary internal fixation device, and contouring is

absolutely necessary, it is recommended that such contouring be gradual and great care be used to avoid notching orscratching the surface of the device(s). The components should not be repeatedly or excessively bent any more than ab-solutely necessary. The components should not be reverse bent at the same location.

4. The implant surfaces should not be scratched or notched, since such actions may reduce the functional strength of theconstruct.

5. Bone grafts must be placed in the area to be fused and the graft must be extended from the upper to the lower vertebrae tobe fused.

6. Bone cement should not be used since this material will make removal of the components difficult or impossible. The heatgenerated from the curing process may also cause neurologic damage and bone necrosis.

7. Before closing the soft tissues, all of the screws should be seated onto the plate. Recheck the tightness of all screws afterfinishing to make sure that none has loosened during the tightening of the other screws. Also secure the locking screw intoplace to cover the portion of the screw heads which are located at the ends of the plate. Failure to do so may result in screw

loosening. Caution: Excessive torque on the threads may cause the threads to strip in the bone, reducing fixation.

Postoperative:The physician's postoperative directions and warnings to the patient and the corresponding patient compliance, are extremelyimportant.1. Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is rec-

ommended or required prior to firm bony union, the patient must be warned that bending, loosening or breakage of the com-ponents are complications which can occur as a result of excessive or early weight-bearing or excessive muscular activity. Therisk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may beincreased if the patient is active, or if the patient is debilitated, demented or otherwise unable to use crutches or other suchweight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.

2. To allow the maximum chances for a successful surgical result: the patient or device should not be exposed to mechanicalvibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit andrestrict physical activities, especially lifting and twisting motions and any type of sport par ticipation. The patient should be ad-vised not to smoke or consume alcohol during the bone graft healing process.

3. The patient should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this per-manent physical restriction in body motion.

4. If a non-union develops or if the components loosen, bend, and/or break, the device(s) should be revised and/or removedimmediately before serious injury occurs. Failure to immobilize a delayed or non-union of bone will result in excessive andrepeated stresses on the implant. By the mechanism of fatigue these stresses can cause eventual bending, loosening, orbreakage of the device(s). It is important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by roentgenographic examination. The patient must be adequately warned of these hazards andclosely supervised to insure cooperation until bony union is confirmed.

5. The ORION Anterior Cervical Plate System implants are temporary internal fixation devices. Internal fixation devices are de-signed to stabilize the operative site during the normal healing process. After the spine is fused, these devices serve no func-tional purpose and should be removed. In most patients removal is indicated because the implants are not intended to transferor support forces developed during normal activities. If the device is not removed following completion of its intended use, oneor more of the following complications may occur: (1) Corrosion, with localized tissue reaction or pain, (2) Migration of implantposition possibly resulting in injury, (3) Risk of additional injury from post-operative trauma, (4) Bending, loosening and/orbreakage, which could make removal impractical or difficult, (5) Pain, discomfort, or abnormal sensations due to the presenceof the device, (6) Possible increased risk of infection, and (7) Bone loss due to stress shielding.

While the surgeon must make the final decision on implant removal, it is the position of the Orthopedic Surgical ManufacturersAssociation that whenever possible and practical for the individual patient, bone fixation devices should be removed once theirservice as an aid to healing is accomplished, particularly in younger and more active patients. Any decision to remove the deviceshould take into consideration the potential risk to the patient of a second surgical procedure and the difficulty of removal. Implanremoval, should be followed by adequate postoperative management to avoid fracture.6. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible. As with all

orthopaedic implants, none of the ORION Anterior Cervical Plate System components should ever be reused under any cir-cumstances.

Packaging:Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should becarefully checked for completeness and all components should be carefully checked for lack of damage prior to use. Damagedpackages or products should not be used, and should be returned to Sofamor Danek.

Cleaning and Decontamination:All instruments and implants must first be cleaned using established hospital methods before sterilization and introduction into asterile surgical field. Additionally, all instruments and implants that have been previously taken into a sterile surgical field must firs

be decontaminated and cleaned using established hospital methods before sterilization and reintroduction into a sterile surgicalfield. Cleaning and decontamination can include the use of neutral cleaners followed by a deionized water rinse.

Note: Certain cleaning solutions such as those containing bleach or formalin may damage some devices and they must not beused.

All products should be treated with care. Improper use or handling may lead to damage and possible improper functioning of thedevice.

Sterilization:Unless noted otherwise on the package labeling, the ORION Anterior Cervical Plate System components are provided non-sterileThese products need to be steam sterilized by the hospital using one of the following methods:

Method: Steam Method: Steam Method: Steam*Cycle: Pre-Vacuum OR Cycle: Gravity OR Cycle: GravityTemperature: 270F (132C) Temperature: 250F (121C) Temperature: 273F (134 C)Exposure Time: 4 minutes Exposure Time: 30 minutes Exposure Time: 18 minutes

* Because of the potential risk of transmission of Creutzfeldt Jakob disease, some Health Care Authorities recommendsterilization according to these parameters, especially of surgical instruments that could come into contact with the centralnervous system. Remove all packaging materials prior to sterilization. Use only sterile products in the operative field.

Product Complaints:Any Health Care Professional (e.g., customer or user of this system of products), who has any complaints or who hasexperienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/or performance,should notify the distributor, Sofamor Danek. Further, if any of the implanted ORION Anterior Cervical Plate System component(sever malfunctions, (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or issuspected of doing so, the distributor should be notified immediately. If any Sofamor Danek product ever malfunctions and mayhave caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephonefax or written correspondence. When filing a complaint, please provide the component(s) name and number, lot number(s), yourname and address, the nature of the complaint and notification of whether a written report from the distributor is requested.

Further Information:Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If furthe

information is needed or required, please contact:

IN USADirector, Customer Service DivisionSofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132

Telephone Numbers: 1-800-876-3133or 901-396-3133

Telefax Numbers: 901-396-0356or 901-332-3920

IN EUROPECustomer Service158, rue de lEglise B. P. 462180 RANG DU FLIERSFRANCE

Telephone Numbers: (33) 3.21.89.50.00(33) 1.49.38.80.00

Telefax Number: (33) 3.21.89.50.09

Sofamor Danek International*13, rue de la Perdrix93290 TREMBLAY EN FRANCE*authorized EC representative

PHYSICIAN NOTE: General information on the use and limitations of these devices may be provided to the patient by detachingat the perforation.

PATIENT INFORMATION: The ORION Anterior Cervical Plate System components are temporary implants* that are intended foranterior interbody screw/plate fixation of the cervical spine during the development of a cervical spinal fusion. The ORION

Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are pre-appended to the plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral bodyof the cervical spine using an anterior approach.

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and con-traindications of spinal instrumentation systems should be well-understood by the surgeon. The system is indicated for use in thetemporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerativedisc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history andradiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5)pseudarthrosis, and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING:This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical,thoracic, or lumbar spine.

The temporary internal fixation devices used in your recent spinal surgery are metallic implants that attach to bone and aid in thehealing of bone grafts. These implants have been shown to be valuable aids to physicians in the treatment of bony fusions.These devices do not have the capabilities of living bone. Intact living bone is self-repairing, flexible, and occasionally breaksand/or degrades. The anatomy of the human body places a size limitation on any artificial fixation device used in surgery. Thismaximum size limitation increases the chances of the mechanical complications of loosening, bending, or breaking of thedevice(s). Any of these complications could result in the need for an additional surgery to remove the device(s) or possibly inserta new one(s). Accordingly, it is very important that you follow your physician's post-operative instructions faithfully. Limit youractivities to those your surgeon recommends. Use crutches, braces, canes and/or other weight-bearing or assist devices as longas recommended by your physician. By following these instructions you can increase your chances of a successful result and re-duce your risk of injury and/or additional surgery.

1998 Sofamor Danek. All rights reserved.

Sofamor, SNCRCS Bobigny B 617 320 486

3/98 0380095

Important Information On TheORIONAnterior Cervical Plate System


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For product availability, labeling limitations, and/or more information on any Medtronic Sofamor Danek products,contact your MEDTRONIC SOFAMOR DANEK USA, INC. Sales Associate,

or call MEDTRONIC SOFAMOR DANEK USA, INC. Customer Service toll free: 800-933-2635.

MEDTRONIC SOFAMOR DANEK USA, INC.1800 Pyramid Place Memphis, TN 38132

(901) 396-3133 (800) 876-3133Customer Service: (800) 933-2635

www.sofamordanek.com

orion anterior st

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