blue mountain - qualgenix · internal fixation appliances are load-sharing devices that are used to...

Anterior cervical arthrodesis

Blue Mountain surgical techniqueQualgenix


surgical technique

Blue Mountain

Qualgenix



Summary

1

Introduction

Pre operative planning

Approach

Installing the Caspar distractor

Disk resection

Selecting Plate Length

Installation

2

3-4

5

6

7

8

9-12

Removal

Implant / Instrument references

13

16-17




surgical technique

Blue Mountain

Qualgenix

Summary

1

Introduction

Pre operative planning

Approach


Disk resection

Selecting Plate Length

Installation

2

3-4

5

6

7

8

9-12

Removal

Implant / Instrument references

13

16-17

2

Introduction

Thank you for choosing the Qualgenix Blue Mountainplate system for your operation of cervical spinearthrodesis.

Blue Mountain range • Ideal for procedures on one to four levels. • Ten plate lengths of between 29 and 93 mm. • 4.0 mm screws • 4.5 mm screws for revision

The Qualgenix Blue Mountain Cervical Plate is intended for anterior screw �xation at the vertebral bodies of the cervical spine (C2-C7). The Qualgenix Blue Mountain Cervical Plate is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as de�ned by neck pain in discogenic origin of the disc con�rmed by patient history and radiographic studies with degeneration of the disc), spinal stenosis, spondylolisthesis, deformity (de�ned as kyphosis, lordosis, and scoliosis), trauma (including fractures), tumors, pseudoarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine. The device is intended for anterior cervical intervertebral body fusions only.

Instruction For Use delivered with Blue Mountain Implants.

INDICATIONS:

3

Pre Operative Planning

• Active systemic infection or an infection localized to the site of the proposed implantation. • Severe osteoporosis may prevent adequate fixation of screws and thus preclude the use of this or any other spinal instrumentation system. • Patients who have been shown to be safely and predictably treated without internal fixation. • Open wounds.

Relative ContraindicationsRelative contraindications include any entity or condition that totally precludes the possibility of fusion (e.g., cancer, kidney dialysis or osteopenia), obesity, certain degenerative diseases, and foreign body sensitivity. Warnings and CautionsThese warnings do not include all possible adverse surgical e�ects, but are particular to metallic internal �xation devices. Explain general surgical risks to the patient before surgery.

Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of �xation, nonunion, vertebral fracture, neurological injury, and vascular or visceral injury.

• CORRECT IMPLANT SELECTION IS VITAL. Selecting the proper implant size, shape, and design increases the potential for satisfactory �xation While proper selection can help minimize risks, the size and shape of human bones present implant size, shape, and strength limitations. Metallic internal �xation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. • IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices that 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 among other conditions will dictate implant longevity. Notches, scratches or implant bending during the surgery may also contribute to early failure. Fully inform patients of the implant failure risks. • 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 �lms. 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, wires, etc.,that come into contact with other metal objects, must be made from like or compatible materials. • This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

PATIENT SELECTION: The following factors can be extremely important to the eventual success of the procedure:

• 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. • Senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the device use, leading to implant failure or other complications. • Certain degenerative diseases. In some cases, degenerative disease progression may be so advanced at implantation that it may substantially decrease the device’s expected useful life. For such cases, orthopedic devices can only be considered a delaying technique or temporary remedy. • Foreign body sensitivity. No pre-operative 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. • Smoking. Patients who smoke have been observed to experience higher rates of pseudoarthrosis following surgical procedures where bone graft is used. Additionally, smoking has been shown to cause di�use 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.

GENERAL CONTRAINDICATIONS:

4


WARNING: If bony fusion does not occur within an expected period of time, the screws may break due to the high and sustained loading of these devices. This has been noted in patients with pseudoarthrosis, delayed or non-union and can result in the need to revise the device(s).

WARNING: These devices are not approved for screw attachment or �xation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

CAUTIONS:

• Only experienced spinal surgeons with specific training in the use of this cervical plate spinal system should implant cervical plate spinal systems, because this is a technically demanding procedure presenting a risk of serious injury to the patient.

• SURGICAL IMPLANTS MUST NEVER BE REUSED. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.

• CORRECT IMPLANT HANDLING IS VITAL. Only contour metal implants with proper equipment. Avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface �nish and internal stresses that may become the focal point for eventual breakage. Do not use the implant if damage is suspected. Excessive torque applied to the screws when seating the plate may cause bone failure resulting in stripped threads and/or compromised screw purchase.

• BENDING THE CONSTRUCT. Titanium alloy components should never be bent sharply or reverse bent. If a construct is over-contoured contour a new construct correctly rather than reverse bending the over-contoured construct.

• IMPLANT REMOVAL AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur:

• Corrosion, with localized tissue reaction or pain; • Implant migration resulting in injury; • Risk of additional injury from postoperative trauma; • Bending, loosening, and/or breakage, which could make removal impractical or difficult; • Pain, discomfort, or abnormal sensations due to device presence; • Possible increased risk of infection; • Bone loss due to stress shielding. 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 or deformity. If the patient is older and has a low activity level, the surgeon may choose not to remove implant thus eliminating the risks involved in a second surgery.

• 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. Inform the patient about the implant limitations, and to limit physical activities, especially lifting and twisting motions and participating in any type of sports. Tell the patient 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.

Approach

Patient positionThe operating table should be inclined in order to lower the blood pressure.

The patient should be in a supine position with head held slightly tilted to the left and arms extended along the body.

5

6


Distraction Intervertebral decompression isachieved using the ratchet on theCaspar distractor.

Installing the pinsDeploy the Caspar pins using theholder for temporary pin.

When both pins are in place, distractioncan be performed.

+Pin for Caspar distractor

108D12S1 length 12mm 109D14S1 length 14mm

Caspar distractor and pins 058DCC1 108D12S1

109D14S1

Holder for temporary pin 118HTP1

7

Disk resectionResection of the damaged disk material using a curette, a pituitaryforceps or a Kerrison (not supplied standard in the instrument set).

Disk resection

After the disc is removed, the FDA-cleared cage is packed with autograft for fusion.

Example: cervical arthrodesis with an FDA-cleared interbody cage

8

SIZERSIMPLANTS

Sizers of exactly the same dimensions as the implants are used to determine thesize of the definitive implant.

BM2P24 24 1.8 12.5

BM2P29 29 1.8 9.8

BM2P34 34 1.8 9.8

BM2P41 41 1.8 9.8

BM2P46 46 1.8 9.8

BM2P50 50 1.8 9.8

BM2P58 58 1.8 10.8

BM2P66 66 1.8 10.8

BM2P75 75 1.8 10.8

BM2P93 93 1.8 10.8

134D24CP1

135D29CP1

136D34CP1

137D41CP1

138D46CP1

139D50CP1

140D58CP1

141D66CP1

142D75CP1

143D93CP1

LengthReference ReferenceThickness Width

Caliper 156DCAL2

Holder for cervical plate116HPC1

The Caliper is an alternative to thesizer method: the spread gives thesize of the implant to be used.

Select the right-sized plate.

All m

easu

rem

ents

are

in m

illim

eter

. (m

m)

Thickness

WidthLength

Sizers

Selecting the plate length

Plate length direct reading

Preparation of the implant

Once the right-sized plate has beenidentified, it can be bowed using theplate bender.

OK

Bowing the plate

Only use the plate bender on the shaft of the plate otherwise you risk damaging the locking system.

Plate bender115BP1

Bowed plate

Straight plate

Blue Mountain surgical techniqueQualgenix 9

Plate setting

With the temporary pins in place, holes

for the distal screws can be drilled.

Use the sharp tip to pierce the anteriorcortex of the vertebra.

Sharp Tip

111PSTC1

The plate can be held in position with just two pins at opposite corners. Deploy the temporary pins using the pin holder.

The holder is used to install the cervicalplate on the vertebra

Holder for cervical plate 116HPC1

Installing the temporary pins

Installing the definitive implant

1011

Preparing screw holes

The color of the stop corresponds to the drilling depth.

Two di�erent drill bits correspond tothe two di�erent screw diameters. • 2.4 mm drill for screws Ø 4.0 mm • 2.9 mm drill for screws Ø 4.5 mm

Taps of two di�erent diameterscorrespond to the di�erent diameters ofthe cervical screws.

Tap for cervical screws112P40CT1 for 4.0mm screws113P45CT1 for 4.5mm screws

Lg 12 150H12S1

Lg 14 151H14S1

Lg 16 152H16S1

Lg 18 153H18S1

Lg 20 154H20S1

Range of stops for drill

Drill guide, cervical plate

119HCG2

Drilling

Tapping

for screw 4.0 mm

Drill guide with stop

! Stop for drill are pushed on theguide with a

rotatory motion

CDépartement du Rhône/Jean Jacques Guttin.

Blue mountain o�ers two screwsdiameter: 4.0mm and 4.5mm.Select the suitable screw diameter.

4.5

4.0

drill bit 2.4 120P24D1


A drill guide permits to control thedirection of drilling. Various stops willset the length of drill that penetratesthe bone cortex. Use the stop thatcorresponds to the expected lengthof drilling. Stops for drill are pushed on the guidewith a rotatory motion.

Installing distal screws

Selection

Screwdriver, retaining, hex 2.5 mm, cervical

114SCP2

Blue Mountain screws are designed with self drilling and self tapping threadingprofile. Select a screw of the correct diameter and length. However drill bits andtaps are delivered standard with the instrument set. We recommend the use ofdrills and taps to maximize bone purchase during screw insertion.

12 1214 1416 161820 20

18

4.0 4.54.0 4.54.0 4.54.04.0 4.5

4.5

Diam.A Length ( L)

Distal screw

An index on the screw rack permits to check the diameter and length of screws.

L

A

Screws diameter 4mm are generally indicated for first intention surgery.

Screws diameter 4.5 mm are generally indicated for first revision surgery.

As the locking is driven by the screw into the Blue Mountain plate specific profile, Qualgenix recommends surgeons to use the longest possible screws, according to patient vertebral measurements.

Diam.A Length ( L)

Due to its ultra low profile head and position within plate thickness, most of the screw length should penetrate into the bone. The index L shows what length should be inserted into the bone.

Distal screw

12

removal of screw

Selection

If you need to remove an implant, the following technique is recommended.

Attach the handle to the screwdriver shaft, then engage the assembled driver into the drive recess of the screw to be removed. Rotate the driver counterclockwise to �rst loosen the screw from plate.

Note: If multiple screws need to be removed, it is recommended to �rst loosen all screws before any of the screws are removed from the implant. Loosening all screws before removal ensures that implant will be properly secured during removal.

Note: Torque limiting should not be used with driver to remove screws.

13


14

The screwdriver catches the screw from implant rack up to implantation site.Introduce the first distal screw into the hole.

Screw in until the head first comesinto contact with the plate. Do not lock the screw.

ScrewingVissage

Leave the screw head above the platelevel as shown on the picture.

Repeat the piercing, drilling andscrewing operations for the secondhole. Do not lock this second screw into the plate.

Remove one of the temporary pinsand repeat the piercing, drilling and screwing operations for the third hole. Do not lock this third screw into the plate. Repeat for the fourth hole, again without locking.

All four screws are now in place, butthey are not yet locked.

The heads of the screws are stickingout from the surface of the plate.

Before screw locking, check the length andlocation of the screws by radiology or imageintensification (C-arm).

Before locking

!

Once the positions of the plate and the screws have been checked with X-ray control, proceed with screws lockingas follows.

After locking, the heads of the screws

are below the level of the plate.


114SCP2

Before locking, the heads of the screws are above the level

of the plate.

Locking procedure

"CLICK"

Stage 1

increasing resistance is perceived

Stage 2

a «click» is heard or felt in thehand when the head of the screw

disappears into the plate

Stage 3

turn the screw through one more half-turn.

The screw is locked in.

Continue screwing in gently, until:

Then... Then...

Do not overtighten the screw, as it may damage the threading in

bone (as with any kind of bone screw)

Due to the high level of surrounding noise in the operating room, the click sond may not be heard. The screw shall anyway be locked in the plate whenever its head sits below the level of the plate.

15

Locking distal screwsImplant References

16

All measurements are in millimeter (mm)

BM2P24

BM2P46

BM2P75

BM2P29

BM2P93

BM2P34

BM2P58

BM2P66

BM2P41

BM2P50

24 12.5

9.8

9.8

10.8

10.8

10.8

10.8

10.8

10.8

10.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

29

34

58

41

66

46

75

50

93

Cervical plate Thickn

ess

Length

Width Ref

erence

BM1CPS12

12

14

14

16

16

1820

1820

4.0

4.5

4.0

4.5

4.0

4.5

4.04.0

4.54.5

43

Diam.A Diam.ALength LengthReference ReferenceCervical distal screw

Cervical distal screw

Screw for cage fixation

BM1S4012

BM1S4512

BM1S4014

BM1S4514

BM1S4016

BM1S4516

BM1S4018 BM1S4020

BM1S4518 BM1S4520

Implants rack M1BM01

12

12

14

14

16

1618

18

4.0

4.5

4.0

4.5

4.0

4.54.5

4.0

Cervical central screw


BM1SC4012

BM1SC4512

BM1SC4014

BM1SC4514

BM1SC4016

BM1SC4516 BM1SC4518

BM1SC4018

Nb ver

t. fixed

Central

screw

Cage fix

. screw

2

2

2

3

3

3

4

4

5

5

0434

L

ØA

L

ØA

L

ØA

W

T

L

Implant References

17


MA

DE

IN F

RA

NC

E 100%

115BP1

Temporary pin, cervical

Caspar distractor with pins


Holder for temporary pin

Caspar pins

Extractor

Tap for cervical screws

Sharp tip, cervical

Screwdriver, retaininghex 2.5mm, cervical

Sizer, cervical plate

Instruments container Rack instruments

143D93CP1 93mm

Measuring caliper, cervical plate

Stop for drill guide

134D24CP1 24mm

135D29CP1 29mm

136D34CP1 34mm

137D41CP1 41mm

138D46CP1 46mm

139D50CP1 50mm

140D58CP1 58mm

141D66CP1 66mm

142D75CP1 75mm

150H12S1

151H14S1

152H16S1

153H18S1

154H20S1

ø 4.0mm

20mm

12mm

ø 4.5mm

18mm

16mm

14mm

12mm

14mm

058DCC1

108D12S1109D14S1

117HCTP1

156DCAL2

116HPC1Drill for cervical screws ø 2.4mm

ø 2.9mm120P24D1121P29D1

155HTR2

118HTP1

112P40CT1113P45CT1

111PSTC1

114SCP2

119HCG2

C1BM01 M1BM02

Length

Drilling length

Reference

Holder for cervical plate

Plate bender

NOTES:

QualgenixQualgenix LLC

1 Jack's Hill Road (Unit 3E)Oxford, CT 06478

www.Qualgenix.com




• Active systemic infection or an infection localized to the site of the proposed implantation. • Severe osteoporosis may prevent adequate fixation of screws and thus preclude the use of this or any other spinal instrumentation system. • Patients who have been shown to be safely and predictably treated without internal fixation. • Open wounds.

Relative ContraindicationsRelative contraindications include any entity or condition that totally precludes the possibility of fusion (e.g., cancer, kidney dialysis or osteopenia), obesity, certain degenerative diseases, and foreign body sensitivity. Warnings and CautionsThese warnings do not include all possible adverse surgical effects, but are particular to metallic internal fixation devices. Explain general surgical risks to the patient before surgery.

Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, nonunion, vertebral fracture, neurological injury, and vascular or visceral injury.

• CORRECT IMPLANT SELECTION IS VITAL. Selecting the proper implant size, shape, and design increases the potential for satisfactory fixation While proper selection can help minimize risks, the size and shape of human bones present implant size, shape, and strength limitations. Metallic internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. • IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NONUNION. Internal fixation appliances are load-sharing devices that 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 among other conditions will dictate implant longevity. Notches, scratches or implant bending during the surgery may also contribute to early failure. Fully inform patients of the implant failure risks. • 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, wires, etc.,that come into contact with other metal objects, must be made from like or compatible materials. • This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

PATIENT SELECTION: The following factors can be extremely important to the eventual success of the procedure:

• 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. • Senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the device use, leading to implant failure or other complications. • Certain degenerative diseases. In some cases, degenerative disease progression may be so advanced at implantation that it may substantially decrease the device’s expected useful life. For such cases, orthopedic devices can only be considered a delaying technique or temporary remedy. • Foreign body sensitivity. No pre-operative 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. • Smoking. Patients who smoke have been observed to experience higher rates of pseudoarthrosis 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.

GENERAL CONTRAINDICATIONS:




WARNING: If bony fusion does not occur within an expected period of time, the screws may break due to the high and sustained loading of these devices. This has been noted in patients with pseudoarthrosis, delayed or non-union and can result in the need to revise the device(s).

WARNING: These devices are not approved for screw attachment or �xation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

CAUTIONS:

• Only experienced spinal surgeons with specific training in the use of this cervical plate spinal system should implant cervical plate spinal systems, because this is a technically demanding procedure presenting a risk of serious injury to the patient.

• SURGICAL IMPLANTS MUST NEVER BE REUSED. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage.

• CORRECT IMPLANT HANDLING IS VITAL. Only contour metal implants with proper equipment. Avoid any notching, scratching or reverse bending of the devices when contouring. Alterations will produce defects in surface �nish and internal stresses that may become the focal point for eventual breakage. Do not use the implant if damage is suspected. Excessive torque applied to the screws when seating the plate may cause bone failure resulting in stripped threads and/or compromised screw purchase.

• BENDING THE CONSTRUCT. Titanium alloy components should never be bent sharply or reverse bent. If a construct is over-contoured contour a new construct correctly rather than reverse bending the over-contoured construct.

• IMPLANT REMOVAL AFTER HEALING. If the device is not removed after the completion of its intended use, any of the following complications may occur:

• Corrosion, with localized tissue reaction or pain; • Implant migration resulting in injury; • Risk of additional injury from postoperative trauma; • Bending, loosening, and/or breakage, which could make removal impractical or difficult; • Pain, discomfort, or abnormal sensations due to device presence; • Possible increased risk of infection; • Bone loss due to stress shielding. 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 or deformity. If the patient is older and has a low activity level, the surgeon may choose not to remove implant thus eliminating the risks involved in a second surgery.

• 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. Inform the patient about the implant limitations, and to limit physical activities, especially lifting and twisting motions and participating in any type of sports. Tell the patient 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.



Approach

Patient positionThe operating table should be inclined in order to lower the blood pressure.

The patient should be in a supine position with head held slightly tilted to the left and arms extended along the body.

5



6


Distraction Intervertebral decompression isachieved using the ratchet on theCaspar distractor.

Installing the pinsDeploy the Caspar pins using theholder for temporary pin.

When both pins are in place, distractioncan be performed.

+Pin for Caspar distractor

108D12S1 length 12mm 109D14S1 length 14mm

Caspar distractor and pins 058DCC1 108D12S1

109D14S1

Holder for temporary pin 118HTP1



7

Disk resectionResection of the damaged disk material using a curette, a pituitaryforceps or a Kerrison (not supplied standard in the instrument set).

Disk resection

After the disc is removed, the FDA-cleared cage is packed with autograft for fusion.

Example: cervical arthrodesis with an FDA-cleared interbody cage



SIZERSIMPLANTS

Sizers of exactly the same dimensions as the implants are used to determine thesize of the definitive implant.

BM2P24 24 1.8 12.5

BM2P29 29 1.8 9.8

BM2P34 34 1.8 9.8

BM2P41 41 1.8 9.8

BM2P46 46 1.8 9.8

BM2P50 50 1.8 9.8

BM2P58 58 1.8 10.8

BM2P66 66 1.8 10.8

BM2P75 75 1.8 10.8

BM2P93 93 1.8 10.8

134D24CP1

135D29CP1

136D34CP1

137D41CP1

138D46CP1

139D50CP1

140D58CP1

141D66CP1

142D75CP1

143D93CP1

LengthReference ReferenceThickness Width

Caliper 156DCAL2

Holder for cervical plate116HPC1

The Caliper is an alternative to thesizer method: the spread gives thesize of the implant to be used.

Select the right-sized plate.

All m

easu

rem

ents

are

in m

illim

eter

. (m

m)

Thickness

WidthLength

Sizers

Selecting the plate length

Plate length direct reading



Preparation of the implant

Once the right-sized plate has beenidentified, it can be bowed using theplate bender.

OK

Bowing the plate

Only use the plate bender on the shaft of the plate otherwise you risk damaging the locking system.

Plate bender115BP1

Bowed plate

Straight plate




Plate setting

With the temporary pins in place, holes

for the distal screws can be drilled.

Use the sharp tip to pierce the anteriorcortex of the vertebra.

Sharp Tip

111PSTC1

The plate can be held in position with just two pins at opposite corners. Deploy the temporary pins using the pin holder.

The holder is used to install the cervicalplate on the vertebra

Holder for cervical plate 116HPC1

Installing the temporary pins

Installing the definitive implant

10



Preparing screw holes

The color of the stop corresponds to the drilling depth.

Two di�erent drill bits correspond tothe two di�erent screw diameters. • 2.4 mm drill for screws Ø 4.0 mm • 2.9 mm drill for screws Ø 4.5 mm

Taps of two di�erent diameterscorrespond to the di�erent diameters ofthe cervical screws.

Tap for cervical screws112P40CT1 for 4.0mm screws113P45CT1 for 4.5mm screws

Lg 12 150H12S1

Lg 14 151H14S1

Lg 16 152H16S1

Lg 18 153H18S1

Lg 20 154H20S1

Range of stops for drill


119HCG2

Drilling

Tapping

for screw 4.0 mm

Drill guide with stop

! Stop for drill are pushed on theguide with a

rotatory motion

CDépartement du Rhône/Jean Jacques Guttin.

Blue mountain o�ers two screwsdiameter: 4.0mm and 4.5mm.Select the suitable screw diameter.

4.5

4.0



A drill guide permits to control thedirection of drilling. Various stops willset the length of drill that penetratesthe bone cortex. Use the stop thatcorresponds to the expected lengthof drilling. Stops for drill are pushed on the guidewith a rotatory motion.




Selection


114SCP2

Blue Mountain screws are designed with self drilling and self tapping threadingprofile. Select a screw of the correct diameter and length. However drill bits andtaps are delivered standard with the instrument set. We recommend the use ofdrills and taps to maximize bone purchase during screw insertion.

12 1214 1416 161820 20

18

4.0 4.54.0 4.54.0 4.54.04.0 4.5

4.5

Diam.A Length ( L)

Distal screw

An index on the screw rack permits to check the diameter and length of screws.

L

A

Screws diameter 4mm are generally indicated for first intention surgery.

Screws diameter 4.5 mm are generally indicated for first revision surgery.

As the locking is driven by the screw into the Blue Mountain plate specific profile, Qualgenix recommends surgeons to use the longest possible screws, according to patient vertebral measurements.

Diam.A Length ( L)

Due to its ultra low profile head and position within plate thickness, most of the screw length should penetrate into the bone. The index L shows what length should be inserted into the bone.

Distal screw

12



removal of screw

Selection

If you need to remove an implant, the following technique is recommended.

Attach the handle to the screwdriver shaft, then engage the assembled driver into the drive recess of the screw to be removed. Rotate the driver counterclockwise to �rst loosen the screw from plate.

Note: If multiple screws need to be removed, it is recommended to �rst loosen all screws before any of the screws are removed from the implant. Loosening all screws before removal ensures that implant will be properly secured during removal.

Note: Torque limiting should not be used with driver to remove screws.

13




14

The screwdriver catches the screw from implant rack up to implantation site.Introduce the first distal screw into the hole.

Screw in until the head first comesinto contact with the plate. Do not lock the screw.

ScrewingVissage

Leave the screw head above the platelevel as shown on the picture.

Repeat the piercing, drilling andscrewing operations for the secondhole. Do not lock this second screw into the plate.

Remove one of the temporary pinsand repeat the piercing, drilling and screwing operations for the third hole. Do not lock this third screw into the plate. Repeat for the fourth hole, again without locking.

All four screws are now in place, butthey are not yet locked.

The heads of the screws are stickingout from the surface of the plate.

Before screw locking, check the length andlocation of the screws by radiology or imageintensification (C-arm).

Before locking

!



Once the positions of the plate and the screws have been checked with X-ray control, proceed with screws lockingas follows.

After locking, the heads of the screws

are below the level of the plate.


114SCP2

Before locking, the heads of the screws are above the level

of the plate.

Locking procedure

"CLICK"

Stage 1

increasing resistance is perceived

Stage 2

a «click» is heard or felt in thehand when the head of the screw

disappears into the plate

Stage 3

turn the screw through one more half-turn.

The screw is locked in.

Continue screwing in gently, until:

Then... Then...

Do not overtighten the screw, as it may damage the threading in

bone (as with any kind of bone screw)

Due to the high level of surrounding noise in the operating room, the click sond may not be heard. The screw shall anyway be locked in the plate whenever its head sits below the level of the plate.

15

Locking distal screws



Implant References

16


BM2P24

BM2P46

BM2P75

BM2P29

BM2P93

BM2P34

BM2P58

BM2P66

BM2P41

BM2P50

24 12.5

9.8

9.8

10.8

10.8

10.8

10.8

10.8

10.8

10.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

1.8

29

34

58

41

66

46

75

50

93

Cervical plate Thickn

ess

Length

Width Ref

erence

BM1CPS12

12

14

14

16

16

1820

1820

4.0

4.5

4.0

4.5

4.0

4.5

4.04.0

4.54.5

43

Diam.A Diam.ALength LengthReference ReferenceCervical distal screw

Cervical distal screw

Screw for cage fixation

BM1S4012

BM1S4512

BM1S4014

BM1S4514

BM1S4016

BM1S4516

BM1S4018 BM1S4020

BM1S4518 BM1S4520

Implants rack M1BM01

12

12

14

14

16

1618

18

4.0

4.5

4.0

4.5

4.0

4.54.5

4.0



BM1SC4012

BM1SC4512

BM1SC4014

BM1SC4514

BM1SC4016

BM1SC4516 BM1SC4518

BM1SC4018

Nb ver

t. fixed

Central

screw

Cage fix

. screw

2

2

2

3

3

3

4

4

5

5

0434

L

ØA

L

ØA

L

ØA

W

T

L



Implant References

17


MA

DE

IN F

RA

NC

E 100%

115BP1

Temporary pin, cervical

Caspar distractor with pins


Holder for temporary pin

Caspar pins

Extractor

Tap for cervical screws

Sharp tip, cervical

Screwdriver, retaininghex 2.5mm, cervical

Sizer, cervical plate

Instruments container Rack instruments

143D93CP1 93mm

Measuring caliper, cervical plate

Stop for drill guide

134D24CP1 24mm

135D29CP1 29mm

136D34CP1 34mm

137D41CP1 41mm

138D46CP1 46mm

139D50CP1 50mm

140D58CP1 58mm

141D66CP1 66mm

142D75CP1 75mm

150H12S1

151H14S1

152H16S1

153H18S1

154H20S1

ø 4.0mm

20mm

12mm

ø 4.5mm

18mm

16mm

14mm

12mm

14mm

058DCC1

108D12S1109D14S1

117HCTP1

156DCAL2

116HPC1Drill for cervical screws ø 2.4mm

ø 2.9mm120P24D1121P29D1

155HTR2

118HTP1

112P40CT1113P45CT1

111PSTC1

114SCP2

119HCG2

C1BM01 M1BM02

Length

Drilling length

Reference

Holder for cervical plate

Plate bender



NOTES:



QualgenixQualgenix LLC

1 Jack's Hill Road (Unit 3E)Oxford, CT 06478

www.Qualgenix.com

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