MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHICS - BASIC BIMAXILLARY SURGICAL KIT

Model Number	SD980.003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was designed and manufactured according to specifications.Additional investigation is still ongoing.
Event or Problem Description
The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative it appeared the occlusion did not match the planned outcome, while during surgery no occlusion discrepancies were detected.The patient needs revision surgery, surgery not yet planned.
Additional Manufacturer Narrative
Final report: guides were designed according to specifications but were not placed according to the plan during the surgery.
Event or Problem Description
The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative it appeared the occlusion did not match the planned outcome, while during surgery no occlusion discrepancies were detected.The patient had revision surgery.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH ORTHOGNATHICS - BASIC BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 8554420
• Report Number: 3003998208-2019-00018
• Device Sequence Number: 19444028
• Product Code: JEY
• UDI-Device Identifier: 05420060380037
• UDI-Public: 05420060380037
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SD980.003
• Device Catalogue Number: SD980.003
• Device Lot Number: ME19VIZLOD
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention