condylar head add-on system. adjustable system for condylar head...

Condylar Head Add-on System. Adjustable system for condylar head reconstruction.

Surgical Technique

This publication is not intended for distribution in the USA.

Instruments and implants approved by the AO Foundation.

Image intensifier control

This description alone does not provide sufficient background for direct use of DePuy Synthes products. Instruction by a surgeon experienced in handling these products is highly recommended.

Processing, Reprocessing, Care and MaintenanceFor general guidelines, function control and dismantling of multi-part instruments, as well as processing guidelines for implants, please contact your local sales representative or refer to:http://emea.depuysynthes.com/hcp/reprocessing-care-maintenanceFor general information about reprocessing, care and maintenance of Synthes reusable devices, instrument trays and cases, as well as processing of Synthes non-sterile implants, please consult the Important Information leaflet (SE_023827) or refer to: http://emea.depuysynthes.com/hcp/reprocessing-care-maintenance

Introduction Condylar Head Add-on System 2

AO Principles 4

Intended use, Indications, Contraindications, 5 Warnings, General Adverse Events and MRI Information

Surgical Technique 7

Product Information Implants 17

Sets 23

Bibliography 26

Condylar Head Add-on System Surgical Technique DePuy Synthes 1

Table of Contents

2 DePuy Synthes Condylar Head Add-on System Surgical Technique

System Overview

Condylar Head Add-on System. Adjustable system for condylar head reconstruction.

The Synthes Condylar Head Add-on System is designed to provide temporary reconstruction of the mandibular condyle in patients undergoing disarticulation resection of the man-dible as part of ablative tumor surgery.

The Synthes Condylar Head Add-on is attached to a Recon-struction Plate with a fixation plate and two set screws.

Important: The Condylar Head Add-on System must only be used with the MatrixMANDIBLE Reconstruction Plates 2.5 mm or 2.8 mm thick or 2.4 UniLOCK Reconstruction Plates.

Condylar Head Add-on – Maintains temporary function of temporomandibular joint – Oval head for a large contact area – Offset in a medial direction for anatomically correct

positioning of the implant – Highly polished oval head – Symmetrical design allows right or left placement

Fixation plates – Fixation plate for height-adjustment allows optimal

fit of the condylar head in the patient’s glenoid fossa

– Four different positions: 0 mm to 6 mm, in 2 mm increments

– Labeled to identify position height


Used with reconstruction platesThe Condylar Head Add-on System is used with a recon-struction plate. It can be used with either of the following systems: – MatrixMANDIBLE – the condylar head add-on can attach

to either the 2.5 mm thick reconstruction plate or the 2.8 mm thick reconstruction plate

– 2.4 UniLOCK reconstruction plate

Optimal fit in the patient’s glenoid fossaTo achieve optimal fit in the patient’s glenoid fossa, the system includes four fixation plates which allow height adjustment of the condylar head add-on relative to the proximal end of the reconstruction plate (from 0 mm to 6 mm in 2 mm increments).

Set screws – Two screws are used to attach the condylar head add-on

and fixation plate to the reconstruction plate – The MatrixMANDIBLE screw is color-coded light blue and

has a self-holding MatrixMANDIBLE screwdriver blade recess

– The 2.4 UniLOCK screw is color-coded gray for identifica-tion and has a self-holding cruciform screwdriver blade recess


AO Principles

In 1958, the AO formulated four basic principles, which have become the guidelines for internal fixation.1 These principles, as applied to the Condylar Head Add-on System, are:

Anatomic reductionThe height adjustment of the condylar implant allows resto-ration of facial form and anatomic relationships, including the occlusion.

Stable fixationThe condylar implant allows stable fixation when used with a MatrixMANDIBLE Reconstruction Plates 2.5 mm or 2.8 mm thick or 2.4 UniLOCK Reconstruction Plate.

Preservation of blood supplyUse of surgical technique preserves the blood supply to soft tissue and bone, minimizes disruption of soft tissue and pre-serves vascular blood flow for bone healing.

Early, active mobilizationThe Condylar Head Add-on System preserves facial form and symmetry; permits jaw movement, chewing function and speech; and improves quality of life.

1 Müller ME, Allgöwer M, Schneider R, and Willenegger H. Manual of Internal Fixation. 3rd ed. Berlin, Heidelberg, New York: Springer. 1991.


Intended use, Indications, Contraindications, Warnings, General Adverse Events and MRI Information

Intended UseThe Condylar Head Add-on System is intended for tempo-rary reconstruction of the mandibular condyle.

IndicationsThe Condylar Head Add-on System is indicated for tempo-rary reconstruction of the mandibular condyle in patients undergoing ablative surgery requiring the removal of the mandibular condyle.

ContraindicationsThe Condylar Head Add-on System is contraindicated for use as a permanent prosthetic device, for patients with temporo-mandibular joint disorders (TMD), or patients with traumatic injuries to the temporomandibular joint (TMJ). These devices are offered STERILE and NONSTERILE. These devices are intended for single use only.

Warnings: – The use of the Condylar Head Add-on System is not

intended for permanent reconstruction. – When inserting the implant, it is important that the oper-

ative surgeon ensures that a soft tissue interface, such as the natural articulating disc or soft tissue graft resides between the implant head (device) and the bone.

– Direct metal-to-bone contact between the condylar com-ponent of the device and the natural glenoid fossa should be avoided. The procedure is contraindicated if no soft tissue is present.

– Improper placement of the implant due to surgical tech-nique may lead to contralateral joint dysfunction. Care must be taken to ensure that the plate is positioned verti-cally in the fossa. A potential “open bite” deformity may result if this vertical position is altered.

– This device is not intended to be loaded in order to re-establish complete function. Normal bite forces may not be tolerated by the implant.

– These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final deci-sion on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed.

– Instruments and screws may have sharp edges or moving joints that may pinch or tear user’s glove or skin.


Magnetic Resonance environment

Torque, Displacement and Image Artifacts according to ASTM F2213-06, ASTM F2052-06e1 and ASTM F2119-07Non-clinical testing of worst case scenario in a 3 T MRI sys-tem did not reveal any relevant torque or displacement of the construct for an experimentally measured local spatial gradient of the magnetic field of 5.4 T/m. The largest image artifact extended approximately 31 mm from the construct when scanned using the Gradient Echo (GE). Testing was conducted on a 3 T MRI system.

Radio-Frequency-(RF-)induced heating according to ASTM F2182-11aNon-clinical electromagnetic and thermal simulations of worst case scenario lead to temperature rises of 13.7°C (1.5 T) and 6.5°C (3 T) under MRI Conditions using RF Coils (whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes).

Precautions: The above mentioned test relies on non-clini-cal testing. The actual temperature rise in the patient will de-pend on a variety of factors beyond the SAR and time of RF application. Thus, it is recommended to pay particular atten-tion to the following points: – It is recommended to thoroughly monitor patients under-

going MR scanning for perceived temperature and/or pain sensations.

– Patients with impaired thermoregulation or temperature sensation should be excluded from MR scanning proce-dures.

– Generally, it is recommended to use an MRI system with low field strength in the presence of conductive implants. The employed specific absorption rate (SAR) should be reduced as far as possible.

– Using the ventilation system may further contribute to reduce temperature increase in the body.

Intended use, Indications, Contraindications, Warnings, General Adverse Events and MRI Information


Surgical Technique

The following steps are additional to the surgical technique for the MatrixMANDIBLE System (DSEM/CMF/0814/0025) and Compact 2.4 UniLOCK System (DSEM/CMF/0216/0115).

1Determine surgical approach

If possible, place the patient in MMF to maintain the poste-rior ramus height and the occlusion.

Surgeon preference determines the surgical approach.

Note: Most disarticulation resections and condylar head/reconstruction plate placements will occur with transcutaneous access.

2Measure ramus height

Prior to the resection, measure the patient’s ramus height from the tip of the condyle to the bottom of the ramus (angle).


Surgical Technique

3Select and cut and/or contour reconstruction plate

Select the appropriate reconstruction plate to match the planned resection and measured ramus height.

Cut and/or contour the plate to match the patient’s anatomy.

Refer to the MatrixMANDIBLE Surgical Technique (DSEM/ CMF/0814/0025) or Compact 2.4 UniLOCK Surgical Technique (DSEM/CMF/0216/0115) for plate contouring and mandible resection.

The Condylar Head Add-on System will add between 11 mm to 17 mm of height to the vertical (ramus) end of the plate.

Warning: Ensure the plates are free from burrs/sharp edges after cutting.


Note: Use bending screws to prevent plate hole deformation while contouring the plate.

Warning: After resection, the ramus height and the anteroposterior (AP) length must be maintained.

Note: It is recommended that the plate’s ramus section is cut one hole longer than anticipated to ensure proper fit.

Warning: To ensure proper fit of the Condylar Head Add-on on the reconstruction plate, the last three holes in the region of the mandibular ramus should not be bent or restricted.


Surgical Technique

4Position reconstruction plate

From an anterior approach, clamp the plate to the mandible using two plate holding forceps.

Precaution: It is essential to hold and stabilize the plate using the plate holding forceps, as its weight can disrupt vertical position, potentially causing an “open bite” deformity.


5Position condylar head add-on

Instruments for MatrixMANDIBLE Reconstruction Plates

03.503.070 Screwdriver Shaft MatrixMANDIBLE, short, self-holding, for Hexagonal Coupling

or 03.503.071 Screwdriver Shaft MatrixMANDIBLE,

medium, self-holding, for Hexagonal Coupling

or03.503.072 Screwdriver Shaft MatrixMANDIBLE, long,

self-holding, for Hexagonal Coupling

Instrument for 2.4 UniLOCK Reconstruction Plate

314.447 Screwdriver Shaft 2.4, cruciform, self-holding, for Quick Coupling

Before securing the plate, place the patient in temporary MMF to maintain posterior ramus height.

Place the neutral fixation plate (position 0 mm) onto the condylar head, and fasten to the lateral aspect of the recon-struction plate using the screwdriver blade and two set screws.

Note: Secure set screws to the assembly until snug. Verify that no play exists in the assembly. Do not over-tighten.

Position the assembled condylar head add-on in the fossa ensuring that there is enough room for the natural articular disc or a soft tissue graft.

0 mm position

2 mm position

4 mm position

6 mm position


If additional ramus height is required to properly seat the condylar head into the fossa, up to 6 mm of height can be added by using different fixation plates (2 mm, 4 mm or 6 mm).

If the ramus height is excessive, one or more holes can be cut from the ramus section of the reconstruction plate and the fixation plates can be used to adjust the height of the condylar head.

For example, cutting one hole section (8 mm long) from the reconstruction plate, then using the 6 mm fixation plate with the condylar head will yield a net reduction of 2 mm in ramus height.

Surgical Technique


6Secure Reconstruction Plate to distal fragment

Instruments for MatrixMANDIBLE Reconstruction Plates

03.503.044 Drill Sleeve 1.8, short, with thread, for MatrixMANDIBLE

03.503.046 Drill Sleeve 2.4, short, with thread, for MatrixMANDIBLE

03.503.070 Screwdriver Shaft MatrixMANDIBLE, short, self-holding, for Hexagonal Coupling

or 03.503.071 Screwdriver Shaft MatrixMANDIBLE,

medium, self-holding, for Hexagonal Coupling

or03.503.072 Screwdriver Shaft MatrixMANDIBLE, long,

self-holding, for Hexagonal Coupling

03.503.461 Drill Bit B 1.8 mm, length 90 mm, for J-Latch Coupling*, for 03.503.044

03.503.471 Drill Bit B 2.4 mm, length 90 mm, for J-Latch Coupling*, for 03.503.046

Instruments for 2.4 UniLOCK Reconstruction Plate

310.520 Drill Bit B 1.8 mm, length 125 mm, 2-flute, for Quick Coupling

310.540 Drill Bit B 2.4 mm, length 125 mm, 2-flute, for Quick Coupling

314.447 Screwdriver Shaft 2.4, cruciform, self-holding, for Quick Coupling

397.441 Drill Sleeve 1.8, with thread, for UniLOCK Reconstruction Plates


* Drill bits with mini quick coupling also available.


Precautions: – Drill speed rate should never exceed 1,800 rpm, particu-

larly in dense, hard bone. Higher drill speed rates can re-sult in: – thermal necrosis of the bone, – soft tissue burns, – an oversized hole, which can lead to reduced pullout

force, increased ease of the screws stripping in bone, suboptimal fixation, and/or the need for emergency screws.

– Always irrigate during drilling to avoid thermal damage to the bone.

– Irrigate and apply suction for removal of debris potentially generated during implantation or removal.

– Avoid drilling over nerve or tooth roots. – Take care while drilling as to not damage, entrap, or tear a

patient’s soft tissue or damage critical structures. – Be sure to keep drill clear of loose surgical materials. – Handle devices with care and dispose worn bone cutting

instruments in an approved sharps container.

Surgical Technique


Before securing the plate, ensure that the patient is in temporary MMF.

Once the plate and the Condylar Head Add-on implant are positioned properly, use at least four screws to secure the plate to the mandible.

For 2.4 mm screws, use the 1.8 mm drill bit and 1.8 mm threaded drill guide. For 2.9 mm screws (or 3.0 mm when us-ing 2.4 UniLOCK plates), use the 2.4 mm drill bit and 2.4 mm threaded drill guide.

Refer to the Surgical Technique of MatrixMANDIBLE (DSEM/CMF/0814/0025) / Compact 2.4 UniLOCK (DSEM/CMF/0216/ 0115) for detailed plate application.

Note: In osteoporotic bone, MatrixMANDIBLE 2.9 mm LOCK screws / UniLOCK 3.0 mm locking screws are recommended.


Surgical Technique

7Check the fit of the condylar head in the glenoid fossa

Remove the patient from MMF and check to ensure that the condylar head articulates properly in the fossa.


Implants

04.449.000/ Condylar Head Add-on 04.449.000S

04.449.010/ Fixation Plate for Condylar Head Add-on,04.449.010S Position 0 mm




04.497.000/ Set Screw for Condylar Head Add-on04.497.000S (for use with 2.4 UniLOCK plates)

04.497.001/ MatrixMANDIBLE Set Screw for Condylar04.497.001S Head Add-on (for use with MatrixMANDI-

BLE Reconstruction Plates)


Implants

The following plates can be used with the Condylar Head Add-on System

MatrixMANDIBLE Reconstruction Plates

04.503.739/ MatrixMANDIBLE Reconstruction Plate,04.503.739S angled, left, 7+23 holes, thickness

2.5 mm, Pure Titanium

04.503.740/ MatrixMANDIBLE Reconstruction Plate,04.503.740S angled, right, 7+23 holes, thickness

2.5 mm, Pure Titanium

04.503.741/ MatrixMANDIBLE Reconstruction Plate,04.503.741S double-angled, small, thickness 2.5 mm,

Pure Titanium, sterile

04.503.742/ MatrixMANDIBLE Reconstruction Plate,04.503.742S double-angled, medium, thickness

2.5 mm, Pure Titanium, sterile

04.503.743/ MatrixMANDIBLE Reconstruction Plate,04.503.743S double-angled, large, thickness 2.5 mm,

Pure Titanium, sterile


04.503.772/ MatrixMANDIBLE Reconstruction Plate, 04.503.772S angled, left, 7+23 holes,

thickness 2.8 mm, Pure Titanium

04.503.773/ MatrixMANDIBLE Reconstruction Plate,04.503.773S angled, right, 7+23 holes,

thickness 2.8 mm, Pure Titanium


Implants

2.4 mm cortex, 2.4 mm and/or 2.9 mm MatrixMANDIBLE LOCK screws used to secure the MatrixMANDIBLE Reconstruction Plates to the mandible

04.503.435.01C– MatrixMANDIBLE Screws B 2.4 mm,04.503.448.01C self-tapping, Titanium Alloy (TAN),04.503.435.04C– length 5 to 18 mm04.503.448.04C

04.503.638.01C– MatrixMANDIBLE LOCK Screws 04.503.648.01C B 2.4 mm, self-tapping, 04.503.638.04C– Titanium Alloy (TAN), length 8 to 18 mm04.503.648.04C

04.503.465.01C– MatrixMANDIBLE Emergency Screws 04.503.478.01C B 2.7 mm, self-tapping, Titanium Alloy (TAN), length 5 to18 mm

04.503.668.01C– MatrixMANDIBLE LOCK Screws 04.503.678.01C B 2.9 mm, self-tapping, 04.503.668.04C– Titanium Alloy (TAN), length 8 to 18 mm04.503.678.04C


449.628/ UniLOCK Reconstruction Plate 2.4, angled,449.628S right, 13+5 holes, length 110/40 mm,

Pure Titanium

449.629/ UniLOCK Reconstruction Plate 2.4, angled,449.629S left, 13+5 holes, length 110/40 mm,

Pure Titanium

449.636/ UniLOCK Reconstruction Plate 2.4,449.636S double-angled, 4+20+4 holes,

length 33/162/33 mm, Pure Titanium





2.4 UniLOCK Reconstruction Plates

449.626/ UniLOCK Reconstruction Plate 2.4, angled,449.626S left, 21+6 holes, length 170/50 mm,

Pure Titanium

449.627/ UniLOCK Reconstruction Plate 2.4, angled,449.627S right, 21+6 holes, length 170/50 mm,

Pure Titanium


2.4 mm cortex, 2.4 mm and/or 3.0 mm UniLOCK screws used to secure the 2.4 UniLOCK Reconstruction Plates to the mandible

401.506– MF Cortex Screws B 2.4 mm, self-tapping, 401.540 Pure Titanium, gold, length 6 to 40 mm

401.558– Emergency Screws B 2.7 mm, self-tapping,401.568 Pure Titanium, blue, length 8 to 18 mm

497.668– UniLOCK Screws B 2.4 mm, self-tapping,497.682 Pure Titanium, violet, length 8 to 22 mm

497.690– UniLOCK Screws B 3.0 mm, self-tapping, 497.697 Pure Titanium, turquoise, length 8 to 22 mm

Implants


Sets

Insert for Implants for Condylar Head Add-on System, for use with MatrixMANDIBLE Reconstruction Plates and 2.4 UniLOCK Plates (61.449.000.01)

Fits in the auxiliary bin of the MatrixMANDIBLE Compact Recon (Art. No. 61.503.840) and Compact 2.4 UniLOCK (DSEM/CMF/0216/0115).

Required sets

For 2.5 mm thick (blue) or 2.8 mm thick (gold)MatrixMANDIBLE Reconstruction Plates

01.503.831 Instrument Set for MatrixMANDIBLE Recon

01.503.834 MatrixMANDIBLE Recon Plates

01.503.836 MatrixMANDIBLE Recon Screwsor 01.503.831 Instrument Set for MatrixMANDIBLE Recon

01.503.840 MatrixMANDIBLE Compact Recon

For 2.4 UniLOCK Reconstruction Plates

01.504.034 Compact 2.4 UniLOCK

01.502.093 Standard Instruments Compact 2.4 Mandible


Sets

Set for use with 2.4 UniLOCK Reconstruction Plates (01.449.000)

61.449.000 Module for Condylar Head Add-on System

Implants Quantity

04.449.000 Condylar Head Add-on 4

04.449.010 Fixation Plate for Condylar 3 Head Add-on, Position 0 mm




04.497.000 Set Screw for Condylar Head 10 Add-on

449.626 UniLOCK Reconstruction 1 Plate 2.4, angled, left, 21+6 holes, length 170/50 mm, Pure Titanium

449.627 UniLOCK Reconstruction 1 Plate 2.4, angled, right, 21+6 holes, length 170/50 mm, Pure Titanium


Instruments Quantity

310.520 Drill Bit B 1.8 mm, length 125 mm, 1 2-flute, for Quick Coupling

310.540 Drill Bit B 2.4 mm, length 125 mm, 1 2-flute, for Quick Coupling

311.230 Tap for Cortex Screws 1 B 2.4 mm,length 100/45 mm

314. 447 Screwdriver Shaft 2.4, cruciform, 2 self-holding, for Quick Coupling

397.441 Drill Sleeve 1.8, with thread, 1 for UniLOCK Reconstruction Plates

329.409 Bending Template, angled, 1 21+6 holes, for UniLOCK Reconstruction Plate 2.4

497.689 Bending Screw for UniLOCK 8 Reconstruction Plates, Pure Titanium

Additionally available

311.243 Tap for UniLOCK Screws 3.0 mm, length 100/45 mm


Additional instruments Additionally needed instruments for plate cutting and bend-ing are included in the Standard Instruments Compact 2.4 Mandible set (Art. No. 01.502.093).


Bibliography

AO/ASIF. Bridging of a Defect of the Mandible: UniLOCK Plate 2.4. Video. Art. No. 21040

Carlson ER. Disarticulation resections of the mandible: a prospective review of 16 cases. J Oral Maxillofac Surg 2002; 60: 176–181

Driemel O, Buch RS, Dammer R, Reicheneder C, Reichert TE, Pistner H. Metallische Halbendoprothesen zum Ersatz des Kiefergelenkkopfes [Metallic condylar head prostheses to replace the temporomandibular joint]. Mund Kiefer Gesichts-chir 2005; 9 (2): 71–79

Driemel O, Carlson ER, Müller-Richter U, Moralis A, Lienhard S, Wagener S, Reichert TE. Neu entwickeltes Kiefergelenk-kopfimplantat zur temporären Kondylus-Rekonstruktion in der ablativen Tumorchirurgie [New condylar head system for temporary condylar reconstruction in ablative tumour surgery]. Mund Kiefer Gesichtschir 2007; 11 (4): 193–199

Prein J (editor). Manual of Internal Fixation in the Cranio- Facial Skeleton. Berlin: Springer. 1998.

Rutherford AS, Ellis E 3rd. Use of a locking reconstruction bone plate/screw system for mandibular surgery. J Oral Max-illofac Surg 1998; 56: 1261–1265

Schmocker R. Universelle Rekonstruktionsplatte URP 2.4. Swiss Dent 1996; 17 (4).

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Synthes GmbHEimattstrasse 34436 OberdorfSwitzerlandTel: +41 61 965 61 11Fax: +41 61 965 66 00www.depuysynthes.com

Not all products are currently available in all markets.

This publication is not intended for distribution in the USA.

All surgical techniques are available as PDF files at www.depuysynthes.com/ifu ©

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condylar head add-on system. adjustable system for condylar head...

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