MAUDE Adverse Event Report: MATERIALISE USA, LLC TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI

Model Number	SD980.016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Malunion of Bone (4529)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon has reported that mandible hardware is being removed due to post-op complications.
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The surgeon has reported that mandible hardware is being removed due to post-op complications.
Additional Manufacturer Narrative
The investigation concluded that the device met the specifications.Investigation showed that the patient has specific mandible anatomy which could complicate the healing process.Additional information was requested to understand the reasons for the nonunion of bones, but not obtained after several attempts.Thus, the exact root cause remained unknown.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MA 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MA 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MA 48170
• MDR Report Key: 21125421
• Report Number: 3005718816-2025-00001
• Device Sequence Number: 7677413
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: MU24TUZBOP
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2024
• 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 Age: 19 YR
• Patient Sex: Female