MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH CMF; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED IMPLANT FOR MANDIBLE, SMALL

Model Number	SD980.107
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Event or Problem Description
Surgery went fine.Malocclusion and scans showed that mandible plate broke on both sides.According to the surgeon root cause is that patient is grinding at night and stressed the plate.Revision surgery planned for (b)(6) 2025.
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 went fine.Malocclusion and scans showed that mandible plate broke on both sides.According to the surgeon root cause is that patient is grinding at night and stressed the plate.Revision surgery is planned.

• Brand Name: TRUMATCH CMF
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED IMPLANT FOR MANDIBLE, SMALL
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 21918593
• Report Number: 3003998208-2025-00002
• Device Sequence Number: 8720159
• Product Code: JEY
• UDI-Device Identifier: 05420060381072
• UDI-Public: 05420060381072
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173039
• 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): 04/10/2025

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: SD980.107
• Device Catalogue Number: SD980.107
• Device Lot Number: MU25FICHIQ
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2025
• 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 Age: 59 YR
• Patient Sex: Female