SYNPOR HD FACIAL SHAPE SYSTEM For the augmentation or reconstruction of the craniomaxillofacial skeleton SURGICAL TECHNIQUE
Table of Contents Introduction SynPOR HD Facial Shape System 2 Indications and Contraindications 4 Preoperative Considerations Evaluation and Planning 5 Material 5 Handling 5 Preparation 5 Surgical Technique (Chin) Approaches 6 Sizing and Shaping 7 Implantation 9 Stabilization 10 Surgical Technique (Malar) Approaches 11 Sizing and Shaping 12 Implantation 14 Stabilization 15 Product Information 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. SynPOR HD Facial Shape System Technique Guide DePuy Synthes
SynPOR HD Facial Shape System. For the augmentation or reconstruction of the craniomaxillofacial skeleton. Introduction SynPOR HD Facial Shape Implants are designed for augmenting the contours of the craniofacial skeleton. Each implant is anatomically shaped to minimize the need for intraoperative contouring. 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 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 skeleton while avoiding impingement of the infraorbital nerve Two styles (shell and enhancer) are offered in a range of sizes to address patient needs Malar implant, left side, viewed from above 2 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
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 SynPOR HD Facial Shape System Technique Guide DePuy Synthes 3
Indications and Contraindications Indications Synthes 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 Contraindications Synthes 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. 4 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
Preoperative Considerations Evaluation and planning Successful 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. Material SynPOR 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 smoothsurface implants. 2 Handling SynPOR 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 exposure 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 SynPOR HD Facial Shape System Technique Guide DePuy Synthes 5
Surgical Technique: Chin 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 accurate 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. 6 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
2 Sizing and shaping Instrument 03.540.004 Cutting Board Chin sizer, round Chin sizer, square 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). Optional Sizers 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 sterilized 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. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 7
Surgical Technique: Chin Optional: Contouring SynPOR 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. 8 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
3 Implantation 1 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. 2 Registration tab 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 conform 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 instances, there will be a gap between the medial aspects of the implant halves (Figure 3). 3 Medial gap SynPOR HD Facial Shape System Technique Guide DePuy Synthes 9
Surgical Technique: Chin 4 Stabilization Instrument 03.540.003 Implant Positioning 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 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 thermally generated necrosis of the bone and an oversized hole to be drilled. The detriments of an oversized 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. 10 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
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 centimeter beyond the area for augmentation. The large pocket allows 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. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 11
Surgical Technique: Malar 2 Sizing and shaping Instrument 03.540.004 Cutting Board Malar Sizer, Enhancer 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. Malar Sizer, Shell Rinse the implant thoroughly in sterile saline to remove any particle debris after contouring (cutting or burring). Optional Sizers 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 sterilized 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. 12 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
Optional: Contouring SynPOR 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. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 13
Surgical Technique: Malar 3 Implantation Instrument Lateral tab 03.540.003 Implant Positioning 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. Medial tab 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. 14 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
4 Stabilization Instrument 03.540.003 Implant Positioning 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. 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 just anterior 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 oversized 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 Facial Shape System Technique Guide DePuy Synthes 15
Implants SynPOR HD Implants Must be ordered separately, not part of set (01.540.100) A C 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 B A 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 C B 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 A C B 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 A C B 16 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
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 Facial Shape System Technique Guide DePuy Synthes 17
Instruments SynPOR HD Sizer, chin, round 03.540.100 4 mm 03.540.101 6 mm 03.540.102 9 mm SynPOR HD Sizer, chin, square 03.540.110 4 mm 03.540.111 6 mm 03.540.112 9 mm SynPOR HD Sizer, malar enhancer 03.550.100 Right, 3 mm 03.550.101 Left, 3 mm 03.550.102 Right, 4 mm 03.550.103 Left, 4 mm 03.550.104 Right, 5 mm 03.550.105 Left, 5 mm SynPOR HD Sizer, malar shell 03.550.110 Right, 3 mm 03.550.111 Left, 3 mm 03.550.112 Right, 4 mm 03.550.113 Left, 4 mm 03.550.114 Right, 5 mm 03.550.115 Left, 5 mm 03.540.003 Implant Positioning Instrument 18 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
03.540.004 Cutting Board 03.507.005 2.4 mm Drill Guide 347.98 Plate Holding Forceps 311.006 Screwdriver Handle with hex coupling, medium 1.1 mm Drill Bit, 65 mm, J-latch 03.540.010 12 mm stop 03.540.012 25 mm stop 03.503.202 MatrixMIDFACE Screwdriver Blades, hex coupling, self-retaining, 76 mm SynPOR HD Facial Shape System Technique Guide DePuy Synthes 19
SynPOR HD Facial Shape System Set (01.540.100) Trays and Modules 60.540.001 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 Markers 60.540.007 Label Sheet for SynPOR HD Facial Shape System Screw Length Markers, for self-drilling screws (1/pkg.) 304.106W 6 mm 304.108W 8 mm Screw Length Markers, for self-tapping screws (10/pkg.) 304.110 10 mm 304.112 12 mm 304.114 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. Instruments SynPOR HD Sizer, chin, round 03.540.100 4 mm 03.540.101 6 mm 03.540.102 9 mm SynPOR HD Sizer, chin, square 03.540.110 4 mm 03.540.111 6 mm 03.540.112 9 mm SynPOR HD Sizer, malar enhancer 03.550.100 Right, 3 mm 03.550.101 Left, 3 mm 03.550.102 Right, 4 mm 03.550.103 Left, 4 mm 03.550.104 Right, 5 mm 03.550.105 Left, 5 mm 04.540.001 SynPOR HD Titanium Chin Connector 20 DePuy Synthes SynPOR HD Facial Shape System Technique Guide
Instruments SynPOR HD Sizer, malar shell 03.550.110 Right, 3 mm 03.550.111 Left, 3 mm 03.550.112 Right, 4 mm 03.550.113 Left, 4 mm 03.550.114 Right, 5 mm 03.550.115 Left, 5 mm 03.540.003 Implant Positioning Instrument 03.540.004 Cutting Board 03.507.005 2.4 mm Drill Guide 347.98 Plate Holding Forceps 311.006 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. MatrixMIDFACE Screwdriver Blades, hex coupling 03.503.201 Self-retaining, 52 mm 03.503.203 Self-retaining, 96 mm 03.503.205 with Spring Holding Sleeve, short 03.503.206 with Spring Holding Sleeve, long Module Lid 60.540.006 Fixation Module Lid for SynPOR HD Facial Shape System Screw Length Markers, for self-tapping screws (10/pkg.) 304.106 6 mm 304.108 8 mm 304.116 16 mm 304.118 18 mm Hot Water Bath System (530.509) consists of: 530.510 Water Bath Heater 530.512 Water Bath Tray 530.514 Water Bath Sterility Cover 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 References 1. 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 Reconstruction of the Internal Orbit. Journal of Oral and Maxillofacial Surgery, 62: 1280 1297. Instruments Screwdriver Handle with hex coupling 311.005 Small 311.007 Large 1.1 mm Drill Bit, 65 mm, mini quick coupling 03.540.011 12 mm stop 03.540.013 25 mm stop * MatrixMIDFACE Screws are 1.55 mm diameter. MatrixMIDFACE Emergency Screws are 1.85 mm diameter. SynPOR HD Facial Shape System Technique Guide DePuy Synthes 21
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. DePuy Synthes CMF 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 www.depuysynthes.com Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 DePuy Synthes CMF, a division of DOI 2013. All rights reserved. J10813-B 3/13