PATIENT SPECIFIC PLATES FOR MANDIBLE Custom made plates for trauma and reconstruction Derived from patient CT data Customizable design features Strength with low profile This publication is not intended for distribution in the USA. PRODUCT OVERVIEW INTRODUCTION TRUMATCH® CMF Solutions seamlessly integrate virtual surgical planning, intraoperative patient specific tools and personalized implants to help achieve surgeon’s goals of accuracy, efficiency and patient benefit. The design of the TRUMATCH CMF Patient Specific Plates for Mandible is individually engineered to meet the needs of each patient and surgeon. By selecting plate design f eatures, surgeons can customize the reconstruction plate to create a patient specific solution. The Patient Specific Plates for Mandible are manufactured to the planned patient anatomy, eliminating the time needed for intraoperative adaption and creating a stronger plate* with a lower overall profile. INTENDED USE AND INDICATIONS Intended use Patient Specific Plates for Mandible are intended for oral, maxillofacial surgery. Indications • Trauma • Reconstructive surgery Clinical applications may include • Comminuted fractures • Fractures of edentulous and atrophic mandibles • Unstable and/or infected mandibular fractures • Primary and secondary mandibular reconstruction (used with vascularized or non-vascularized bone graft) • Temporary bridging with delayed secondary reconstruction * Patient Specific Plates for Mandible fatigue testing data shows increased fatigue life of both 2.0 and 2.5 mm profiles in comparison with Matrix MANDIBLE 2.5 mm thick plates. Test data does not indicate clinical performance. Test data on file at Synthes. ** Manufactured by Materialise and distributed by DePuy Synthes. For full description of TRUMATCH CMF Solutions visit www.trumatchcmf.com FEATURES AND BENEFITS Derived from patient CT data Design fits the planned outcome for easy positioning of the grafts at the planned location. Integration with TRUMATCH CMF virtual surgical planning service** for seamless transfer of the surgical plan into the OR, using TRUMATCH CMF patient specific surgical guides** with built-in drill guides that align with the plate holes (optional). Customizable design features Screw hole positions and angulations defined individually to avoid screw interference with nerves, tooth roots, osteotomies, existing or future implants. Screw length prediction and pre-visualization of screw trajectories to ensure a collision free construct. Strength with low profile 2.0 mm and 2.5 mm plate thicknesses for improved fatigue strength* with lower profiles compared to standard reconstruction plates. DESIGN EXAMPLES Reconstruction involving one angle Angle to angle plates Condyle to condyle plates PATIENT SPECIFIC PLATES FOR MANDIBLE DESIGN STEPS Choose plate profile The Patient Specific Plates for Mandible are available in two plate profiles: • 2.0 mm thick • 2.5 mm thick 2.5 mm 8.0 mm 2.0 mm Design plate Plates are designed to meet the planned outcome anatomy, originating from: • Virtual surgical plan • CT scan data • Independent planning, completed using a virtual surgical plan and submitted with an STL file Select screw hole pattern relative to • Planned osteotomy or resection site • Patient anatomy, for example tooth roots and nerves • Existing or future implants, such as plates, screws or dental implants Define additional features • Use with MatrixMANDIBLE Condylar Head Add-on, if needed Define additional features • TRUMATCH CMF patient specific surgical guides** with built-in drill guides that align with the plate holes, for planned cases Surgical Guide ** Max. 15º Define screw hole angulation • Angulations of 0° to 15° • MatrixMANDIBLE conical threaded screw holes WORKFLOW 1 PLACE REQUEST Patient Specific Plates Request for service: Mandible plates Patient Specific Plates Request for service: Mandible Plates Hospital name Additional information: Draw on diagram: 1. Resection lines and bone graft segments 2. Plate position (see Note 4) 3. Screw holes position in native bone and graft (spare holes included) 4. Indicate screw preferences using the screw coding defined in the inset Exact shipping address Screw coding Diameters (mm): 2.0, 2.4, 2.9 Length: Bicortical / Monocortical Type: Locking / Non-locking Example bicortical locking screw: 2.4 BL = 2.4 mm Sales consultant Patient number/name Date of planned surgery (YYYY/MM/DD) The information requested on this page is mandatory. Patient anatomy data provided via: � Synthes ProPlan CMF. Case ID: � Need ProPlan CMF planning session (use form 036.001.287) � STL file of the planned outcome (provided to Synthes) � Plate shall be designed to native anatomy (see Note 1) Plate thickness: � 2.0 mm (see Note 2) Standard configuration desired: � Yes, design plate per standard configuration as defined in Note 3. � No, plate configuration specified in the next section(s). � 2.5 mm Other requests (require web-based design session): 1. Screw angulation. Identify on the diagram above the screw holes that require angulation for improved access and/or increased stability. The exact angulation has to be defined via the web based design session with Synthes. 2. Special requirements (planned dental implants, etc). If dental implants are planned, mark their approximate position on the diagram above For additional information, refer to next page or propose a date for a web-based design session (YYYY/MM/DD) Note: 4. Indicate the relative position of the plate with respect to inferior/posterior border if different than the alignment defined by the standard plate configuration. 10/2012 Important: – Some clinical situations may require extending the resection beyond the planned limits; consider this when defining the number of screws and the position of the screws next to the osteotomy in native bone. – Please follow CT scan protocol provided by Synthes. Upload the data through an internet connection or ship it per mail. Send the request for custom made device form per mail, e-mail or fax. For more information contact your Synthes representative, visit our website or give us a call. Save Synthes GmbH Eimattstrasse 3 4436 Oberdorf Switzerland www.synthesCSS.com Email [email protected] Phone +41 61 965 6166 Fax +41 61 965 6602 version AA Notes: 1. If virtual planning is not desired and the reconstruction plan is done using other options (e.g. gap bridging, mirroring of opposite side with intra-op graft design, etc.), a web-based design session with Synthes may be necessary. This depends on case complexity. The pre-operative CT scan should be made available to Synthes prior to the design session. 2. The 2.0 mm thick plate can be used for reconstruction with vascularized and non-vascularized bone graft 3. Standard plate configuration − Minimum distance between two adjacent holes: 8 mm (unless otherwise indicated on diagram) − Minimum number of screw holes: 4 per native bone and 2 per graft segment (unless additional information provided) − No collision among screws as long as threaded drill guides are used (or cutting guides with built in drill guides where applicable) − Will be aligned with the inferior and posterior border of the mandible and graft segments Subject to modifications Secondary phone number Secondary e-mail address Synthes is a trademark of Synthes, Inc. or its affiliates E-mail address Secondary contact name © Synthes, Inc. or its affiliates Phone number Country 60100672 City and post code 2/2 036.001.564 Surgeon name 2 DESIGN PLATE 1/2 A Request for Service form must be completed to initiate an order for a Patient Specific Plate for Mandible. The Request for Service form can be obtained via: • Download from www.trumatchcmf.com • Your local DePuy Synthes representative. Follow the instructions on the Request for Service form for submitting applicable patient data, including but not limited to, CT or CBCT data. Patient Specific Plates for Mandible are designed based on the information provided in the first step via the Request for Service form. Some cases may require an Interactive Design Session with a DePuy Synthes engineer, depending on the complexity of the case, or the type of products and services requested. The Interactive Design Session is hosted by a DePuy Synthes engineer. During this session, the engineer will coordinate the details for the plate design with the surgeon and provide a first draft proposal. 3 APPROVE CASE REPORT(S) Hole ID 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Length* (mm) 10 12 10 10 10 10 10 10 10 10 10 18 18 10 10 10 10 10 10 10 10 10 12 Part number 03.503.045** 03.503.476 – 03.503.481** SD900.101*** SD900.102*** Planned Screws Diameter (mm) Lock/ Non-lock 2.4 Lock 2.4 Lock 2.4 Lock 2.0 Lock 2.0 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock 2.4 Lock Part number 04.503.640 04.503.642 04.503.640 04.503.610 04.503.610 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.648 04.503.648 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.640 04.503.642 Additional implants/instruments needed Description Drill Sleeve, long, for MatrixMANDIBLE MatrixMANDIBLE Drill bits (∅1.5, 1.8, 2.4mm) for 03.503.045 Patient Specific Guides, Mandible Patient Specific Guide, Fibula Angled hole Yes Yes Yes No No No No No No No No Yes Yes No No No No No No No Yes Yes Yes Qty 1 1 each 2 1 4 MANUFACTURE & SHIP PLATE 1 2 3 23 22 21 4 20 5 6 7 19 19 18 18 17 17 8 9 10 14 11 12 16 15 13 IMPORTANT: Patient specific implants should not be bent in anyway in order to preserve their mechanical integrity and fit *Screw length is approximate. Surgeon will make the sole determination of the final screw length to be used ** Included in MatrixMANDIBLE Transbuccal Instruments sets 01.503.832 and 01.503.841 ***Manufactured by Materialise and distributed by Synthes Patient Specific Plates for Mandible require surgeon’s approval in order to proceed with manufacture and shipment: • For cases using virtual surgical planning**, an initial Case Report with the planned outcome is provided, prior to proceeding with the plate design. The initial Case Report must be approved via e-mail reply by the surgeon(s) planning the case. • Final approval of the Patient Specific Plates for Mandible and virtual surgical planning** Case Reports may be provided by returning the signed Case Report(s) via fax or e-mail. The Patient Specific Plates for Mandible Case Report contains information about the planned screws, if provided by the surgeon. After the Order for Custom Made Device form has been received, DePuy Synthes starts manufacturing the implant. A non-sterile or sterile implant is shipped to the surgeon. ORDERING PROCESS Start Synthes is a trademark of Synthes, Inc. or its affiliates Feedback to customer OK Quote to customer Redesign3 Yes No Order placed3 Case closed / on hold © Synthes, Inc. or its affiliates No Yes Delivery 60100943 Manufacture Manufacture & Shipment 8 working days Images for approval 1 2 3 Excluding re-design loops Only if case was planned with ProPlan CMF Plate and Surgical Guides (where applicable) Ö036.001.575öAAaä Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf www.depuysynthes.com This publication is not intended for distribution in the USA. All technique guides are available as PDF files at www.synthes.com/lit 12/2013 Design approved3 Approval Depends on customer/ Follow-up Images for approval Subject to modifications Design Design3 version AB Not OK 036.001.575 Verification of request Ordering 4 working days1 Request: RFS, CT/CBCT scan, ProPlan CMF Case number2, STL file