SYNPOR HD FACIAL SHAPE SYSTEM - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · 6 DePuy Synthes SynPOR HD Facial Shape System Technique

SYNPOR® HDFACIAL SHAPESYSTEMFor the augmentation or reconstruction of the craniomaxillofacial skeleton

SURGICAL TECHNIQUE

Table of Contents

SynPOR HD Facial Shape System Technique Guide DePuy Synthes

Introduction

Preoperative Considerations

Surgical Technique (Chin)

Surgical Technique (Malar)

Product Information

SynPOR HD Facial Shape System 2

Indications and Contraindications 4

Evaluation and Planning 5

Material 5

Handling 5

Preparation 5

Approaches 6

Sizing and Shaping 7

Implantation 9

Stabilization 10

Approaches 11

Sizing and Shaping 12

Implantation 14

Stabilization 15

Implants 16

Instruments 18

SynPOR HD Facial Shape System Set 20

References 21

Some devices listed in this technique guide may not have been licensed in accordance with Canadian Law and may not be available for sale in Canada. Please contact your sales consultant for items approved for sale in Cananda.

2 DePuy Synthes SynPOR HD Facial Shape System Technique Guide

SynPOR HD Facial Shape System. For the augmentation or reconstruction of the craniomaxillofacial skeleton.

SynPOR HD Facial Shape Implants are designed for augment-ing the contours of the craniofacial skeleton. Each implant is anatomically shaped to minimize the need for intraoperative contouring.

Introduction

SynPOR HD Malar Implants are designed for craniofacial reconstruction and augmentation of malar deficiencies. SynPOR HD Malar implants are designed to enhance the malar midface and proximal zygomatic arch. Malar implant design features include:

– Registration tabs located medially and laterally to assist in positioning the implant

– Anatomical design that mimics and conforms to the skele-ton while avoiding impingement of the infraorbital nerve

– Two styles (shell and enhancer) are offered in a range of sizes to address patient needs

Features– Registration tabs assist in symmetric and preferred

implant positioning

– Semiflexible material allows the implant to conform to underlying bone during fixation

– Anatomical designs in multiple sizes to meet clinical needs

– Nonabsorbable, biocompatible material

– Porous structure supports fibrovascular ingrowth

– Refined surface characteristics to facilitate insertion

– Easily trimmed with a scalpel or high speed burr

Malar implant, left side, viewed from above

SynPOR HD Facial Shape System Technique Guide DePuy Synthes 3

SynPOR HD Chin Implants augment the contours of the retrusive or hypoplastic chin. SynPOR HD Chin implants are designed to enhance the chin profile and mandibular border. Chin implant design features include:

– Registration tabs on the inferior border to assist in positioning the implant

– Anatomical design that mimics and conforms to skeleton while avoiding impingement of the mental nerve

– Three-part assembly for easier insertion – Flexible titanium connector to allow adjustments for

better anatomic fit and implant positioning– Two styles (round and square) are offered in a range of

sizes to address patient needs

Indications and Contraindications


IndicationsSynthes SynPOR HD Facial Shape Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.

Specific indications:– Enhancement of the malar and chin– Correction of deficiencies of the malar and chin

ContraindicationsSynthes SynPOR HD implants are not intended for use in:– The presence of active or latent infections– Inadequate coverage of healthy, vascularized tissue– Full load-bearing applications or to lend structural

support to bone– Systemic disorders and/or limitations in blood supply

that may cause slow healing and increase the possibility of infection and/or rejection of the implants.

Please refer to package insert for full list of indications, contraindications, warnings and/or precautions.

Preoperative Considerations


Evaluation and planningSuccessful implantation is technique sensitive and requires careful preoperative planning. Preoperative planning should include an understanding of the patient’s desires and an analysis of both the skeleton and the soft tissue envelope. Radiologic evaluation can also be useful for defining the patient skeletal dimensions.

MaterialSynPOR HD Facial Shape Implants are manufactured from an inert, nonabsorbable high density polyethylene (HDPE), which has a long history of use as a surgical implant.1

The implant’s network of open and interconnecting pores, approximately 50% of pores are greater than 100 μm in size, allows tissue ingrowth and relative host incorporation rather than host encapsulation observed with smooth- surface implants.2

HandlingSynPOR HD Facial Shape Implants are provided sterile, for single-patient use. Do not resterilize.

Do not remove SynPOR HD Facial Shape Implants from the protective packaging until the time of implantation.

Handle the implant with clean, powder-free gloves to prevent contamination.

Warning: Do not place implants on surgical drapes, surgical clothing or any other material that may contaminate the implants with lint or other particulate matter. Implants may be placed in sterile saline to prevent contamination.

Preparation SynPOR HD Facial Shape Implants are designed to be placed directly on the recipient bone. Adequate subperiosteal ex-posure is important to allow visualization of the anatomical landmarks and proper placement of the implant.

Warning: Proper aseptic technique is recommended to prevent contamination of the SynPOR HD Facial Shapes Implants when using intraoral incisions.3


1 Approaches

Chin implants can be placed through intraoral or submental approaches. The area for desired augmentation should be exposed by subperiosteal dissection.

The subperiosteal pocket created should extend up to one centimeter beyond the area for augmentation. The large pocket allows easier insertion of the porous implant to which soft tissues tend to adhere and provides perspective for ac-curate implant placement. Exposing the inferior border of the anterior mandible allows positioning of registration tabs which aid in the symmetrical placement of the implant.

Notes:– Shaded region indicates area of subperiosteal dissection.– Identification of the mental nerve lessens the possibility of

implant impingement on this structure.

Surgical Technique: Chin


Chin sizer, round Chin sizer, square

2 Sizing and shaping

Instrument

03.540.004 Cutting Board

SynPOR HD Facial Shape Implants are available in a variety of sizes and styles to minimize the need for alteration. How-ever, implants can be easily trimmed and contoured with a scalpel or high speed burr to suit the individual needs of the patient.

Rinse the implant thoroughly in sterile saline to remove any particle debris after contouring (cutting or burring).

OptionalSizers are available to help determine the proper implant necessary to achieve the desired facial contour for each patient.

Cautions:– The Implant Positioning Instrument is not recommended

to be used with the sizers.– If implants are cut or burred in-situ, take care to remove

all porous polyethylene particles from the surgical site prior to close.

Warnings:– Implants must never be shaped by use of devices that

produce intense heat such as cauteries, heated knives, or lasers.

– Do not implant sizers as they are not intended to be used for permanent augmentation.

– Do not re-use sizers if they have been cut, modified, or damaged. This prevents them from being properly steril-ized and accurately representing their respective implant.

– Do not burr the implant directly on the cutting board. This can lead to damage of the cutting board and debris contamination of the implant.

Notes: – If the implant is burred, reestablish the open pore

structure by shaving the outer surface with a scalpel.– If the midline of the chin implant is modified, it could

affect the implant’s fit with the titanium chin connector.



Optional: ContouringSynPOR HD Facial Shape Implants can be contoured by submerging in hot sterile saline (over 70°C/160°F) for several minutes until the implant softens. Higher temperatures will improve the ability to contour the implant.

Remove the implants from the hot saline and contour to the desired shape. If there is too much resistance, return the implant to the hot saline.

Allow the implant to cool completely to maintain the achieved shape. Cold, sterile saline can accelerate the cooling process.

Reheat the implant as needed to achieve the final form desired.


3Implantation

Instrument

03.540.003 Implant Positioning Instrument

The chin implants consist of right and left halves connected by a titanium connecting bar. The three-piece design facilitates implant insertion. It also allows adjustability in implant positioning.

Registration tabs positioned at the inferior border of the implant assure that the implant is aligned with the inferior border of the mandible and lessens the possibility of impingement on the mental nerve. Removal of the tabs (which can be done easily with a scalpel or burr) allows more superior positioning of the implant.

It may be helpful to mark the midline of the chin with a drill or marking pen to assist in implant placement. Separate the chin implant at the medial junction for two-part insertion.

The Implant positioning Instrument may be used to facilitate placement of the implant.

Align the lateral aspects of the implant along the inferior border of the mandible using the registration tab as a guide (Figure 1). Reconnect the chin implant halves using the titanium connector and determine medial placement (Figure 2). The connecting bar acts as a hinge to allow the implant to con-form to the anatomy and needs of each mandible. As shown in the illustration, the hinge function allows the inferior border of the implant to mimic the specific inclination of the inferior border of any mandible while allowing variability in vertical positioning of the chin prominence. In most ins-tances, there will be a gap between the medial aspects of the implant halves (Figure 3).

1

2

3

Registration tab

Medial gap



4Stabilization

Instrument


SynPOR HD Facial Shape Implants may be stabilized with screws or sutures. Screw fixation is recommended to achieve the best anatomical fit and planned reconstruction.

Screw fixation immobilizes the positioned implant and eliminates any gaps between the inner surface of the implant and the surface of the facial skeleton. Screws placed in the central portion of the chin implant should avoid the titanium connecting bar. Two screws per implant half are recommended.

The Implant Positioning Instrument may be used to immobilize implants during fixation.

Compress the implant to the facial skeleton before drilling and screw fixation.

Drill with the appropriate drill bit and insert the appropriate length screw.

Tighten screws sufficiently to eliminate the gaps between the implant and the facial skeleton as well as to minimize screw profile. Gaps between the implant and the skeleton will result in an unanticipated increase in projection equiva-lent to the size of the gap. This may limit predictability of the augmentation.

Cautions:– Drill rate should never exceed 1,800 rpm. Higher rates can

result in thermally generated necrosis of the bone and an oversized hole to be drilled. The detriments of an over-sized hole include reduced pullout force, increased risk of screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling.

– Confirm that implant positioning, drill bit length, and screw length allow for adequate clearance of nerves, tooth roots, and other critical structures.

Surgical Technique: Malar

1 Approaches

Depending on the surgeon’s preference, malar implants may be placed through intraoral approaches, eyelid approaches, or combinations thereof. The area for desired augmentation should be exposed by subperiosteal dissection.

The subperiosteal pocket should extend up to one centime-ter beyond the area for augmentation. The large pocket al-lows for easier insertion of the porous implants to which soft tissues tend to adhere and provides perspective for accurate implant placement. The lateral aspect of the infraorbital rim and the superior edge of the zygomatic arch should be freed of soft tissues to allow positioning of the registration tabs.

Notes:– Shaded region indicates area of subperiosteal dissection.– Identification of the infraorbital nerve lessens the

possibility of implant impingement on this structure.



2 Sizing and shaping

Instrument


SynPOR HD Facial Shape Implants are available in a variety of sizes and styles to minimize the need for alteration. However, implants can be easily trimmed and contoured with a scalpel or high speed burr to suit the individual needs of the patient.

Rinse the implant thoroughly in sterile saline to remove any particle debris after contouring (cutting or burring).

OptionalSizers are available to help determine the proper implant necessary to achieve the desired facial contour for each patient.

Cautions:– The Implant Positioning Instrument is not recommended

to be used with the sizers.– If implants are cut or burred in-situ, take care to remove

all porous polyethylene particles from the surgical site prior to close.

Warnings:Implants must never be shaped by use of devices that produce intense heat such as cauteries, heated knives, or lasers.– Do not implant sizers as they are not intended to be used

for permanent augmentation.– Do not re-use sizers if they have been cut, modified, or

damaged. This prevents them from being properly steril-ized and accurately representing their respective implant.

– Do not burr the implant directly on the cutting board. This can lead to damage of the cutting board and debris contamination of the implant.

Note: If the implant is burred, reestablish the open pore structure by shaving the outer surface with a scalpel.


Malar Sizer, Enhancer

Malar Sizer, Shell


Optional: ContouringSynPOR HD Facial Shape Implants can be contoured by submerging in hot sterile saline (over 70°C/160°F) for several minutes until the implant softens. Higher temperatures will improve the ability to contour the implant.

Remove the implants from the hot saline and contour to the desired shape. If there is too much resistance, return the implant to the hot saline.

Allow the implant to cool completely to maintain the achieved shape. Cold, sterile saline can accelerate the cooling process.

Reheat the implant as needed to achieve the final form desired.



3Implantation

Instrument


Malar implants are designed with registration tabs which allow ideal and symmetric placement. The medial tab lies on the lateral aspect of the infraorbital rim and the lateral tab lies on the superior edge of the zygomatic arch. If a different orientation is desired, the registration tabs can be removed easily with a scalpel or burr.

The Implant Positioning Instrument may be used to facilitate placement of the implant.

Align the implant along the infraorbital rim and zygomatic arch using the registration tabs on the implant as a guide to ensure symmetrical placement of the left and right implants.

Lateral tab

Medial tab

4Stabilization

Instrument


SynPOR HD Facial Shape Implants may be stabilized with screws or sutures. Screw fixation is recommended to achieve the best anatomical fit and planned reconstruction.

Screw fixation immobilizes the positioned implant and elimi-nates any gaps between the inner surface of the implant and the surface of the facial skeleton.

The Implant Positioning Instrument may be used to immobilize implants during fixation.

Immobilization and application of the malar implant to the skeleton often requires the placement of 2 screws. One is placed in the malar prominence, another is placed justanterior to the zygomatic arch. When an intraoral approach has been used the lateral extent of a blepharoplasty (crow’s feet) incision provides access to the second (lateral) screw position.

Compress the implant to the facial skeleton before drilling and screw fixation.

Drill with the appropriate drill bit and insert the appropriate length screw.

Tighten screws sufficiently to eliminate the gaps between the implant and the facial skeleton as well as to minimize screw profile. Gaps between the implant and the skeleton will result in an unanticipated increase in projection equivalent to the size of the gap. This may limit predictability of the augmentation.

Cautions: – Drill rate should never exceed 1,800 rpm. Higher rates can

result in thermal generated necrosis of the bone, and an oversized hole to be drilled. The detriments of an over-sized hole Include reduced pullout force, increased risk of screws stripping in bone, and/or suboptimal fixation. Always irrigate during drilling.

– Confirm that implant positioning, drill bit length, and screw length allow for adequate clearance of nerves, tooth roots, and other critical structures.



SynPOR HD ImplantsMust be ordered separately, not part of set (01.540.100)

SynPOR HD Chins, Round, sterile A B C

08.540.100S 60 mm 36 mm 4 mm

08.540.101S 60 mm 39 mm 6 mm

08.540.102S 60 mm 41 mm 9 mm

SynPOR HD Chins, Square, sterile A B C

08.540.110S 60 mm 36 mm 4 mm

08.540.111S 60 mm 39 mm 6 mm

08.540.112S 60 mm 41 mm 9 mm

SynPOR HD Malar Enhancers, sterile A B C

08.550.100S Right 48 mm 21 mm 3 mm

08.550.101S Left 48 mm 21 mm 3 mm

08.550.102S Right 47 mm 21 mm 4 mm

08.550.103S Left 47 mm 21 mm 4 mm

08.550.104S Right 48 mm 21 mm 5 mm

08.550.105S Left 48 mm 21 mm 5 mm

SynPOR HD Malar Shells, sterile A B C

08.550.110S Right 44 mm 22 mm 3 mm

08.550.111S Left 44 mm 22 mm 3 mm

08.550.112S Right 47 mm 23 mm 4 mm

08.550.113S Left 47 mm 23 mm 4 mm

08.550.114S Right 52 mm 23 mm 5 mm

08.550.115S Left 52 mm 23 mm 5 mm

Implants

A

C

B

A

C

B

A

C

B

A

C

B


Titanium Implants*

Titanium MatrixMIDFACE Screws, Self-drilling (5/pkg)04.503.226.05 6 mm 04.503.228.05 8 mm Titanium MatrixMIDFACE Screws, Self-tapping (5/pkg)04.503.210.05 10 mm 04.503.212.05 12 mm 04.503.214.05 14 mm

Titanium MatrixMIDFACE Emergency Screws, Self-tapping (1/pkg)

04.503.236.01 6 mm 04.503.238.01 8 mm 04.503.240.01 10 mm 04.503.242.01 12 mm 04.503.244.01 14 mm

04.540.001 SynPOR HD Titanium Chin Connector

* MatrixMIDFACE Screws are 1.55 mm diameter. MatrixMIDFACE Emergency Screws are 1.85 mm diameter.



SynPOR HD Sizer, chin, round03.540.100 4 mm03.540.101 6 mm03.540.102 9 mm

SynPOR HD Sizer, malar enhancer03.550.100 Right, 3 mm03.550.101 Left, 3 mm03.550.102 Right, 4 mm03.550.103 Left, 4 mm03.550.104 Right, 5 mm03.550.105 Left, 5 mm

SynPOR HD Sizer, malar shell03.550.110 Right, 3 mm03.550.111 Left, 3 mm03.550.112 Right, 4 mm03.550.113 Left, 4 mm03.550.114 Right, 5 mm03.550.115 Left, 5 mm

Instruments

SynPOR HD Sizer, chin, square03.540.110 4 mm03.540.111 6 mm03.540.112 9 mm



347.98 Plate Holding Forceps

1.1 mm Drill Bit, 65 mm, J-latch03.540.010 12 mm stop 03.540.012 25 mm stop

03.503.202 MatrixMIDFACE Screwdriver Blades, hex coupling, self-retaining, 76 mm

03.507.005 2.4 mm Drill Guide

311.006 Screwdriver Handle with hex coupling, medium


SynPOR HD Facial Shape System Set (01.540.100)

Trays and Modules60.540.001 Instrument Tray for SynPOR HD

Facial Shape System 60.540.002 Instrument Tray Lid for SynPOR HD

Facial Shape System 60.540.003 Sizer Insert for SynPOR HD

Facial Shape System 60.540.005 Fixation Module for SynPOR HD

Facial Shape System 60.540.010 Instrument Insert for SynPOR HD

Facial Shape System

Label Sheet and Screw Length Markers60.540.007 Label Sheet for SynPOR HD Facial Shape

System

Screw Length Markers, for self-drilling screws (1/pkg.)

304.106W 6 mm304.108W 8 mm

Screw Length Markers, for self-tapping screws (10/pkg.)

304.110 10 mm304.112 12 mm304.114 14 mm

Implants Titanium MatrixMIDFACE Screws,

Self-drilling (5/pkg)04.503.226.05 6 mm, 2 ea. 04.503.228.05 8 mm, 2 ea. Titanium MatrixMIDFACE Screws,

Self-tapping (5/pkg)04.503.210.05 10 mm, 2 ea. 04.503.212.05 12 mm, 2 ea. 04.503.214.05 14 mm, 2 ea.

Titanium MatrixMIDFACE Emergency Screws, Self-tapping (1/pkg)

04.503.236.01 6 mm, 2 ea. 04.503.238.01 8 mm, 2 ea. 04.503.240.01 10 mm, 2 ea. 04.503.242.01 12 mm, 2 ea. 04.503.244.01 14 mm, 2 ea.

04.540.001 SynPOR HD Titanium Chin Connector

Instruments SynPOR HD Sizer, chin, round03.540.100 4 mm03.540.101 6 mm03.540.102 9 mm

SynPOR HD Sizer, chin, square03.540.110 4 mm03.540.111 6 mm03.540.112 9 mm

SynPOR HD Sizer, malar enhancer03.550.100 Right, 3 mm03.550.101 Left, 3 mm03.550.102 Right, 4 mm03.550.103 Left, 4 mm03.550.104 Right, 5 mm03.550.105 Left, 5 mm


Instruments SynPOR HD Sizer, malar shell03.550.110 Right, 3 mm03.550.111 Left, 3 mm03.550.112 Right, 4 mm03.550.113 Left, 4 mm03.550.114 Right, 5 mm03.550.115 Left, 5 mm

03.540.003 Implant Positioning Instrument03.540.004 Cutting Board03.507.005 2.4 mm Drill Guide 347.98 Plate Holding Forceps311.006 Screwdriver Handle with hex coupling,

medium, 2 ea.

1.1 mm Drill Bit, 65 mm, J-latch, 2 ea.03.540.010 12 mm stop 03.540.012 25 mm stop

03.503.202 MatrixMIDFACE Screwdriver Blades, hex coupling, self-retaining, 76 mm, 2 ea.

Also Available

Titanium Implants*Titanium MatrixMIDFACE Screws, self-tapping (5/pkg.)04.503.206.05 6 mm 04.503.208.05 8 mm 04.503.216.05 16 mm 04.503.218.05 18 mm Titanium MatrixMIDFACE Emergency Screws, self-tapping (5/pkg.)04.503.246.05 16 mm 04.503.248.05 18 mm

InstrumentsScrewdriver Handle with hex coupling311.005 Small311.007 Large

1.1 mm Drill Bit, 65 mm, mini quick coupling03.540.011 12 mm stop03.540.013 25 mm stop

* MatrixMIDFACE Screws are 1.55 mm diameter. MatrixMIDFACE Emergency Screws are 1.85 mm diameter.

MatrixMIDFACE Screwdriver Blades, hex coupling03.503.201 Self-retaining, 52 mm 03.503.203 Self-retaining, 96 mm 03.503.205 with Spring Holding Sleeve, short03.503.206 with Spring Holding Sleeve, long

Module Lid60.540.006 Fixation Module Lid for SynPOR HD

Facial Shape System

Screw Length Markers, for self-tapping screws (10/pkg.)304.106 6 mm304.108 8 mm304.116 16 mm304.118 18 mm

Hot Water Bath System (530.509) consists of:530.510 Water Bath Heater 530.512 Water Bath Tray530.514 Water Bath Sterility Cover

References1. Romano, James J., Nicholas T. Iliff. and Paul N. Manson.

“Use of Medpor Porous Polyethylene Implants in 140 Patients with Facial Fractures.” Journal of Craniofacial Surgery 4.3 (1993): 142–47. Print.

2. Yaremchuk, MJ. (2007). Atlas of facial implants. Saunders Elsevier Inc.

3. Potter, J. and Ellis, E. (2004). Biomaterials for Recon- struction of the Internal Orbit. Journal of Oral and Maxillofacial Surgery, 62: 1280–1297.

DePuy Synthes CMF1302 Wrights Lane EastWest Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322

www.depuysynthes.com

© DePuy Synthes CMF, a division of DOI 2013. All rights reserved. J10813-B 3/13

Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.

WARNING: In the USA, this product has labeling limitations. See package insert for complete information.

CAUTION: USA Law restricts these devices to sale by or on the order of a physician.

Not all products are currently available in all markets.

Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

Documents

SYNPOR HD FACIAL SHAPE SYSTEM - synthes.vo.llnwd.netsynthes.vo.llnwd.net/o16/LLNWMB8/US Mobile/Synthes North America... · 6 DePuy Synthes SynPOR HD Facial Shape System Technique