MAUDE Adverse Event Report: MATERIALISE USA, LLC. TRUMATCH CMF; TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT

Model Number	SD980.001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Surgery was completed as usual but post-operation was not as expected.The patient has a class 2 occlusion instead of planned class 1 occlusion.Redo surgery needed to correct occlusion.
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Additional Manufacturer Narrative
The investigation concluded that the devices did not malfunction and there was no deterioration in the characteristics of the performance, and as such the devices met specifications.The exact reason for reported issue could not be established.
Event or Problem Description
Surgery was completed as usual but post-op was not as expected.The patient has a class 2 occlusion instead of planned class 1 occlusion.Redo surgery needed to correct occlusion.

• Brand Name: TRUMATCH CMF
• Common Device Name: TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE USA, LLC.; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC.; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 22461588
• Report Number: 3005718816-2025-00003
• Device Sequence Number: 8560084
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: MU25UGAVIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male