MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE

Model Number	SD980.014
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
Plate was reported broken and explanted four years post initial implantation.
Event or Problem Description
Plate was reported broken and explanted four years post initial implantation.
Additional Manufacturer Narrative
Investigation concluded that device met specifications.The root cause of the plate breaking is due to a lack of bone healing allowing the plate to be loaded beyond the validated load-bearing time.
Additional Manufacturer Narrative
Section d4: serial number has been deleted as it is not present in the label; udi related data quality updates only.Section g6: type of report changed from follow-up #1 to follow-up 2.
Event or Problem Description
Plate was reported broken and explanted four years post initial implantation.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE
• 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: 18273238
• Report Number: 3003998208-2023-00021
• Device Sequence Number: 14841809
• Product Code: JEY
• UDI-Device Identifier: 05420060380143
• UDI-Public: 05420060380143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2023

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: SD980.014
• Device Catalogue Number: SD980.014
• Device Lot Number: MU19XULPEB
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 11/06/2023; 11/06/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 12/21/2023; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2019
• 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: 65 YR
• Patient Sex: Male