SynPOR HD Facial Shape System. For the augmentation or …atlasteb.ir/Uploads/9793_Synpor HD fAcial...

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

Technique Guide

This publication is not intended fordistribution in the USA.

Instruments and implants approved by the AO Foundation

Image intensifier control

WarningThis description alone does not provide sufficient background for direct use ofthe product. Instruction by a surgeon experienced in handling these instruments ishighly recommended.

Reprocessing, Care and Maintenance of Synthes InstrumentsFor general guidelines, function control and dismantling of multi-part instruments,please contact your local sales representative or refer to:www.synthes.com/reprocessing

Table of Contents

Introduction

Surgical Technique

Patient Care

Product Information

SynPOR HD Facial Shape System 2

Intended Use, Indications and Contraindications 4

Preoperative Considerations 5

Surgical Technique: Chin 6

Surgical Technique: Malar 11

Post-Operative Care 17

Implants 18

Instruments 21

SynPOR HD Facial Shape System 24

References 25

SynPOR HD Facial Shape System Technique Guide DePuySynthes 1

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

SynPOR HD Facial Shape Implants are designed for augment-ing or reconstructing the contours of the craniofacial skele-ton. Each implant is designed to minimize the need for intra-operative contouring.

Introduction

Features– Registration tabs assist in symmetric and preferred implantpositioning

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

– Pre-shaped designs in multiple sizes to meet clinical needs

– Nonabsorbable, biocompatible material

– Porous structure supports fibrovascular ingrowth

– Smooth surface characteristics

– Can be trimmed with a scalpel or high speed burr

Malar implant, left side, viewed fromabove

2 DePuySynthes SynPOR HD Facial Shape System Technique Guide

SynPOR HD Malar Implants are designed for craniofacialreconstruction and augmentation of malar deficiencies. SynPOR HD Malar Implants are designed to enhance themalar midface and proximal zygomatic arch. Malar implantdesign features include:

– Registration tabs located medially and laterally to assist inpositioning the implant

– Pre-shaped design mimics and conforms to the skeletonwhile avoiding impingement of the infraorbital nerve

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


SynPOR HD Chin Implants augment or reconstruct thecontours of the retrusive or hypo plastic chin. SynPOR HDChin Implants are designed to enhance the chin profile andmandibular border. Chin implant design features include:

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

– Pre-shaped design mimics and conforms to skeleton whileavoiding impingement of the mental nerve

– Three-part assembly facilitating insertion – Chin connector: Flexible titanium connector to allow adjustments for individual fit and implant positioning

– Two styles (round and square) are offered in a range ofsizes to address patient needs

Intended Use, Indications and Contraindications

Intended useSynthes SynPOR HD Facial Shape Implants are intended forthe augmentation or reconstruction of the craniomaxillofacialskeleton.

The MatrixMIDFACE screws included in the SynPOR HD FacialShape System should be used for fixation of the SynPOR HDFacial Shape Implants.

IndicationsSynthes SynPOR HD Facial Shape Implants are indicated forthe augmentation or reconstruction of the craniomaxillofacialskeleton.

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

ContraindicationsSynthes SynPOR HD Facial Shape Implants are not intendedfor use in:– The presence of active or latent infections– Inadequate coverage of healthy, vascularized tissue– Full load-bearing applications or to lend structural supportto bone

– Systemic disorders and/or limitations in blood supply thatmay cause slow healing and increase the possibility of infection and/or rejection of the implants

– Tissue that has been compromised by cancer therapies– Any degenerative disease process that would adversely affect proper placement of the implants

– Procedures in which a non-sterile environment exists,such as sinuses


Preoperative Considerations

Evaluation and planningSuccessful implantation is technique sensitive and requirescareful preoperative planning. Preoperative planning shouldinclude an understanding of the patient’s desires and ananalysis 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 froman 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% greater than 100 µm in size, allows tissue ingrowth and relative host incorporation rather thanhost encapsulation observed with smooth-surface implants.2

HandlingSynPOR HD Facial Shape Implants are provided sterile, forsingle use.

Warning: Implants must not be resterilized by any method.Resterilizing implants may compromise the mechanical prop-erties and sterility cannot be assured.

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

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

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

Preparation SynPOR HD Facial Shape Implants are designed to be placeddirectly on the recipient bone. Adequate subperiosteal expo-sure is important to allow visualization of the anatomicallandmarks and proper placement of the implant.

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


1Approaches

Chin implants can be placed through intraoral or submentalapproaches. The area for desired augmentation should beexposed by subperiosteal dissection.

The subperiosteal pocket created should extend up to onecentimeter beyond the area for augmentation. The largepocket allows easier insertion of the porous implant to whichsoft tissues tend to adhere and provides perspective for accu-rate implant placement. Exposing the inferior border of theanterior mandible allows positioning of registration tabswhich aid in the symmetrical placement of the implant.


Notes:– Shaded region indicates area of subperiosteal dissection.– Identification of the mental nerve lessens the possibility ofimplant impingement on this structure.

Surgical Technique: Chin


Chin sizer, squareChin sizer, round

2 Sizing and shaping

Instrument

03.540.004 Cutting Board

SynPOR HD Facial Shape Implants are available in a variety ofsizes and styles to minimize the need for alteration. However,implants can be easily trimmed and contoured with a scalpel(using the cutting board provided) or with a high speed burr(holding the implant in your hand) to suit the individualneeds of the patient.

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

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

Precaution: The implant positioning instrument is not rec-ommended to be used with the sizers.

Warnings:– Do not cut or burr the implant in situ.– When shaping and contouring the implant, sharp edgesshould be avoided to minimize trauma to the surroundingtissue.

– Implants must never be shaped by use of devices that produce intense heat such as cauteries, heated knives, orlasers.

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

– Do not re-use sizers if they have been cut, modified, ordamaged. 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 debriscontamination of the implant.

– Do not place implants on surgical drapes, surgical clothingor any other material that may contaminate the implantswith lint or other particulate matter. Implants may beplaced in sterile saline to prevent contamination.


Precautions: – If the implant is burred, reestablish the open pore struc-ture 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 chin connector.



Optional: ContouringSynPOR HD Facial Shape Implants can be contoured by sub-merging in hot sterile saline (over 70°C/160°F) for severalminutes until the implant softens. Higher temperatures willimprove the ability to contour the implant.

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

Allow the implant to cool completely to maintain theachieved shape. Cold, sterile saline can accelerate the cool-ing process.

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

1

2

3

Medial gap

Registration tab

3Implantation

Instrument

03.540.003 Implant Positioning Instrument

The chin implants consist of right and left halves connectedby a chin connector. The three-piece design facilitates im-plant insertion. It also allows adjustability in implant position-ing.

Registration tabs positioned at the inferior border of the implant assure that the implant is aligned with the inferiorborder 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 moresuperior positioning of the implant.

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

The implant positioning instrument may be used to facilitateplacement of the implant.

Align the lateral aspects of the implant along the inferiorborder of the mandible using the registration tab as a guide(Figure 1).

Reconnect the chin implant halves using the chin connectorand determine medial placement (Figure 2). The chin connector acts as a hinge to allow the implant to conform tothe anatomy and needs of each mandible. As shown inthe illustration, the hinge function allows the inferior borderof the implant to mimic the specific inclination of the inferiorborder of any mandible while allowing variability in verticalpositioning of the chin prominence. In most instances, therewill be a gap between the medial aspects of the implanthalves (Figure 3).


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

– Drill rate should never exceed 1,800 rpm. Higher rates canresult in thermally generated necrosis of the bone andan oversized hole to be drilled. The detriments of an over-sized hole include reduced pullout force, increased riskof screws stripping in bone, and/or suboptimal fixation.Always irrigate during drilling.

– The implant can break or be damaged due to lack of fixa-tion, excessive activity or trauma.

– Before closing all incisions, take care to remove all porouspolyethylene particles from the surgical site.

4Stabilization

Instrument


SynPOR HD Facial Shape Implants should be stabilized withscrews. Screw fixation is recommended to achieve the bestanatomical fit and planned reconstruction.

Screw fixation immobilizes the positioned implant and eliminates any gaps between the inner surface of the implantand the surface of the facial skeleton. Screws placed in thecentral portion of the chin implant should avoid the titaniumconnecting bar. Two screws per implant half are recom-mended.

The implant positioning instrument may be used to immobi-lize implants during fixation.

Compress the implant to the facial skeleton before drillingand screw fixation.

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

Tighten screws sufficiently to eliminate the gaps between theimplant and the facial skeleton as well as to minimize screwprofile. Gaps between the implant and the skeleton will re-sult in an unanticipated increase in projection equivalent tothe size of the gap. This may limit predictability of the aug-mentation.



1 Approaches

Depending on the surgeon’s preference, malar implants maybe placed through intraoral approaches, eyelid approaches,or combinations thereof. The area for desired augmentationshould 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 softtissues tend to adhere and provides perspective for accurateimplant placement. The lateral aspect of the infraorbital rimand the superior edge of the zygomatic arch should be freedof soft tissues to allow positioning of the registration tabs.


Notes:– Shaded region indicates area of subperiosteal dissection.– Identification of the infraorbital nerve lessens the possibil-ity of implant impingement on this structure.

Surgical Technique: Malar


Malar Shell Sizer

Malar Enhancer Sizer

2 Sizing and shaping

Instruments


03.550.1XX SynPOR HD Malar Sizers

SynPOR HD Facial Shape Implants are available in a variety ofsizes and styles to minimize the need for alteration. However,implants can be easily trimmed and contoured with a scalpel(using the cutting board provided) or with a high speedburr (holding the implant in your hand) to suit the individualneeds of the patient.

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

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

Precaution: The implant positioning instrument is not rec-ommended to be used with the sizers.

Warnings:– Do not cut or burr the implant in situ.– When shaping and contouring the implant, sharp edgesshould be avoided to minimize trauma to the surroundingtissue.

– 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 usedfor permanent augmentation.

– Do not re-use sizers if they have been cut, modified, ordamaged. 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 debriscontamination of the implant.

– Do not place implants on surgical drapes, surgical clothingor any other material that may contaminate the implantswith lint or other particulate matter. Implants may beplaced in sterile saline to prevent contamination.



Precaution: If the implant is burred, reestablish the openpore structure by shaving the outer surface with a scalpel.

Optional: ContouringSynPOR HD Facial Shape Implants can be contoured by sub-merging in hot sterile saline (over 70°C/160°F) for severalminutes until the implant softens. Higher temperatures willimprove the ability to contour the implant.

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

Allow the implant to cool completely to maintain theachieved shape. Cold, sterile saline can accelerate the cool-ing process.

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


Medial tab

Lateral tab

3Implantation

Instrument


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

The implant positioning instrument may be used to facilitateplacement of the implant.

Align the implant along the infraorbital rim and zygomaticarch using the registration tabs on the implant as a guide toensure symmetrical placement of the left and right implants.



4Stabilization

Instruments


311.00X Handles with Hexagonal Coupling

03.503.20X Screwdriver Shaft Matrix MIDFACE, self-holding, with Hexagonal Coupling

SynPOR HD Facial Shape Implants should be stabilized withscrews. Screw fixation is recommended to achieve the bestanatomical fit and planned reconstruction.

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

The implant positioning instrument may be used to immobi-lize implants during fixation.

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

Compress the implant to the facial skeleton before drillingand screw fixation.

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



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

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

– Drill rate should never exceed 1,800 rpm. Higher rates canresult in thermal generated necrosis of the bone, and anoversized hole to be drilled. The detriments of an over-sized hole include reduced pullout force, increased riskof screws stripping in bone, and/or suboptimal fixation.Always irrigate during drilling.

– The implant can break or be damaged due to lack of fixa-tion, excessive activity or trauma.

– Before closing all incisions, take care to remove all porouspolyethylene particles from the surgical site.


Adequate patient instruction is a key factor in determiningthe success of the surgical procedure. Postoperative follow-up and care are very important. The patient must be madeaware that the implants are not as strong as natural tissueand that excessive physical activity or load bearing may causeloosening, migration, deformation, or fracture of the implants.

Post-Operative Care


A

C

B

A

C

B

A

B

C

A

B

C

C

A

B

C

A

B

A

C

B

C

B

A

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

SynPOR HD Chin Implants, 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

Implants


SynPOR HD Chin Implants, 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 Enhancer Implants, sterile A B C

08.550.100S 48 mm 21 mm 3 mm Right

08.550.101S 48 mm 21 mm 3 mm Left

08.550.102S 47 mm 21 mm 4 mm Right

08.550.103S 47 mm 21 mm 4 mm Left

08.550.104S 48 mm 21 mm 5 mm Right

08.550.105S 48 mm 21 mm 5 mm Left

SynPOR HD Malar Shell Implants, sterile A B C

08.550.110S 44 mm 22 mm 3 mm Right

08.550.111S 44 mm 22 mm 3 mm Left

08.550.112S 47 mm 23 mm 4 mm Right

08.550.113S 47 mm 23 mm 4 mm Left

08.550.114S 52 mm 23 mm 5 mm Right

08.550.115S 52 mm 23 mm 5 mm Left

Screws

MatrixMIDFACE Screws � 1.5 mm, self-drilling, Titanium Alloy (TAN), pack of 1 unit in Clip

Length

04.503.226.01C 6 mm

04.503.228.01C 8 mm


MatrixMIDFACE Screws � 1.5 mm, self-tapping, Titanium Alloy (TAN), pack of 1 unit in Clip

Length

04.503.206.01C 6 mm

04.503.208.01C 8 mm

04.503.210.01C 10 mm

04.503.212.01C 12 mm

04.503.214.01C 14 mm

04.503.216.01C 16 mm

04.503.218.01C 18 mm

MatrixMIDFACE Emergency Screws � 1.8 mm, self-tapping, length 6 mm,Titanium Alloy (TAN), pack of 1 unit in Clip

Length

04.503.236.01C 6 mm

04.503.238.01C 8 mm

04.503.240.01C 10 mm

04.503.242.01C 12 mm

04.503.244.01C 14 mm

04.503.246.01C 16 mm

04.503.248.01C 18 mm

04.540.001 Chin Connector

Screw overview

Pack of 1 unit Pack of 4 units Labelling clips(LC)

Self-tapping screws 04.503.2XX.01C 04.503.2XX.04C 04.503.2XXLC

Self-drilling screws 04.503.22X.01C 04.503.22X.04C 04.503.22XLC

Emergency screws 04.503.2XX.01C – 04.503.2XXLC

Implants



SynPOR HD Malar Shell Sizer 03.550.110 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

SynPOR HD Malar Enhancer Sizer 03.550.100 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 Chin Sizer, square03.540.110 4 mm03.540.111 6 mm03.540.112 9 mm

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

Instruments


Handle with Hexagonal Coupling 311.005 small311.006 medium311.007 large

347.98 Holding Forceps for Plates

03.507.005 Drill Guide 2.4


Instruments


Screwdriver Shaft MatrixMIDFACE, self-holding, with Hexagonal Coupling

03.503.201 Short, length 52 mm

03.503.202 Medium, length 76 mm

03.503.203 Long, length 96 mm

Drill Bit � 1.1 mm, for J-Latch Coupling, with Stop

03.503.246 Length 44.5/6 mm

03.503.248 Length 44.5/8 mm

03.540.010 Length 65/12 mm

03.540.012 Length 65/25 mm

Drill Bit � 1.1 mm, for J-Latch Coupling, with Stop, sterile

03.503.246S Length 44.5/6 mm

03.503.248S Length 44.5/8 mm

Drill Bit � 1.1 mm, for Mini Quick Coupling, with Stop

03.503.286 Length 44.5/6 mm

03.503.288 Length 44.5/8 mm

03.540.011 Length 65/12 mm

03.540.013 Length 65/25 mm

Drill Bit � 1.1 mm, for Mini Quick Coupling, with Stop, sterile

03.503.286S Length 44.5/6 mm

03.503.288S Length 44.5/8 mm


Screwdriver Shaft MatrixMIDFACE, with Holding Sleeve,with Hexagonal Coupling

03.503.205 Medium, length 79 mm

03.503.206 Long, length 95 mm

SynPOR HD Facial Shape System

Sets

01.540.100 Screw and Instrument Set for SynPOR HDFacial Shapes

01.540.110 Chin Implants for SynPOR HDFacial Shapes

01.550.120 Malar Implants for SynPOR HDFacial Shapes

Module

68.540.001 Module for SynPOR HD Facial Shapes,for Implants and Instruments, with Lid,without Contents


1. Romano, James J., Nicholas T. Iliff. and Paul N. Manson.“Use of Medpor Porous Polyethylene Implants in 140Patients with Facial Fractures.” Journal of CraniofacialSurgery 4.3 (1993): 142–47. Print.

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

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

References


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Ö036.001.509öABUä

036.001.509 version AB 12/2013

60100852 © Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates

This publication is not intended for distribution in the USA.

All technique guides are available as PDF files at www.synthes.com/lit

Manufacturer:Synthes GmbHEimattstrasse 3CH-4436 Oberdorfwww.synthes.com

SynPOR HD Facial Shape System. For the augmentation or …atlasteb.ir/Uploads/9793_Synpor HD fAcial...

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