PATIENT SPECIFIC PLATES FOR MANDIBLE: CUSTOM MADE PLATES FOR TRAUMA AND RECONSTRUCTION

Transcription

1 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.

2 PRODUCT OVERVIEW INTRODUCTION The design of the Synthes Patient Specific Plates is customized to meet the individual needs of each patient and surgeon. By selecting plate design features, surgeons can customize the reconstruction plate to create a patient specific solution. The Patient Specific Plates 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 Synthes Patient Specific Plates 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 fatigue testing data shows increased fatigue life of both 2.0 and 2.5 mm profiles in comparison with MatrixMANDIBLE 2.5 mm thick plates. Test data does not indicate clinical performance. Test data on file at Synthes. ** Manufactured by Materialise and distributed by Synthes. For full description see Synthes ProPlan CMF at

3 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 ProPlan CMF** services for seamless transfer of the surgical plan into the OR, using 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

4 PATIENT SPECIFIC PLATES FOR MANDIBLE DESIGN STEPS Choose plate profile The Synthes Patient Specific Plates are available in two plate profiles: 2.0 mm thick 2.5 mm thick 2.0 mm 2.5 mm 8.0 mm Design plate Plates are designed to meet the planned outcome anatomy, originating from: ProPlan CMF** virtual plan CT scan data Independent planning, completed using a 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

5 Define additional features Use with MatrixMANDIBLE Condylar Head Add-on, if needed Define additional features Synthes ProPlan CMF 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

6 Surgeon name Synthes GmbH Eimattstrasse Oberdorf Switzerland psi.eu@synthes.com Phone Fax /2 WORKFLOW 1 PLACE REQUEST 2 DESIGN PLATE Patient Specific Plates Patient Specific Plates Request for service: Request for service: Mandible Plates Mandible plates Hospital name Exact shipping address City and post code Phone number Country address 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 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 Secondary contact name Secondary phone number Secondary address 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 ) 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) 2.5 mm Standard configuration desired: Yes, design plate per standard configuration as defined in Note 3. No, plate configuration specified in the next section(s). For additional information, refer to next page or propose a date for a web-based design session (YYYY/MM/DD) 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 1/2 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 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. 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, or fax. For more information contact your Synthes representative, visit our website or give us a call. Save version AA 10/ Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates A Request for Service form must be completed to initiate an order for a Patient Specific Plate. The Request for Service form can be obtained via: Download from Your local 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 are designed based on the information provided in the first step via the Request for Service form. Some cases may require a Synthes Interactive Design Session with a Synthes engineer, depending on the complexity of the case, or the type of products and services requested. The Synthes Interactive Design Session is hosted by a Synthes engineer. During this session, the engineer will coordinate the details for the plate design with the surgeon and provide a first draft proposal.

7 Planned Screws 3 APPROVE CASE REPORT(S) 4 MANUFACTURE & SHIP PLATE Planned Screws Hole ID Length* (mm) Diameter (mm) Lock/ Non-lock Part number Angled hole Lock Yes Lock Yes Lock Yes Lock No Lock No Lock No Lock No Lock No Lock No Lock No Lock No Lock Yes Lock Yes Lock No Lock No Lock No Lock No Lock No Lock No Lock No Lock Yes Lock Yes Lock Yes Additional implants/instruments needed Part number Description Qty ** Drill Sleeve, long, for MatrixMANDIBLE MatrixMANDIBLE Drill bits ( 1.5, 1.8, 2.4mm) for each ** SD *** Patient Specific Guides, Mandible 2 SD *** Patient Specific Guide, Fibula 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 and ***Manufactured by Materialise and distributed by Synthes Patient Specific Plates require surgeon s approval in order to proceed with manufacture and shipment: For cases using ProPlan CMF** 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 reply by the surgeon(s) planning the case. Final approval of the Synthes Patient Specific Plates and ProPlan CMF** Case Reports may be provided by returning the signed Case Report(s) via fax or . After the Order for Custom Made Device form has been received, Synthes starts manufacturing the implant. A non-sterile or sterile implant is shipped to the surgeon. The Patient Specific Plates Case Report contains information about the planned screws, if provided by the surgeon.

8 ORDERING PROCESS Start 4 working days 1 Depends on customer/ Follow-up 8 working days Request: RFS, CT/CBCT scan, ProPlan CMF Case number 2, STL file Verification of request Quote to customer Design 3 Design approved 3 No Order Case closed / placed 3 on hold Manufacture Delivery OK Images for approval Yes Yes Images for approval Not OK No Synthes GmbH Eimattstrasse 3 CH-4436 Oberdorf Feedback to customer Redesign 3 Approval Design Ordering Manufacture & Shipment Ö öAAaä 1 Excluding re-design loops 2 Only if case was planned with ProPlan CMF 3 Plate and Surgical Guides (where applicable) This publication is not intended for distribution in the USA. All technique guides are available as PDF files at 03/ Synthes, Inc. or its affiliates Subject to modifications Synthes is a trademark of Synthes, Inc. or its affiliates version AA