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

Model Number	SD980.021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The plate was reported broken and additional surgical intervention is planned to remove the device.
Additional Manufacturer Narrative
Investigation concluded that devices met specifications.It is concluded that breakage of the plate is caused by use of the plate without a bone graft causing excessive and prolonged stresses on the plate which is not intended.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, LARGE
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 0032163966
• MDR Report Key: 21323517
• Report Number: 3005718816-2025-00002
• Device Sequence Number: 18266268
• Product Code: JEY
• UDI-Device Identifier: 05420060380211
• UDI-Public: 05420060380211
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 01/07/2025

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: SD980.021
• Device Catalogue Number: SD980.021
• Device Lot Number: MU23AQOBIT
• 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: 01/07/2025
• Initial Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/24/2024
• 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: 54 YR
• Patient Sex: Male