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

Model Number	SD980.014
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
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
A day after the surgery the surgeon had do revision surgery using the same plate to correct bad occlusion (open bite and overjet).

• Brand Name: TRUMATCH CMF
• Common Device Name: 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: 21392749
• Report Number: 3003998208-2025-00001
• Device Sequence Number: 8471340
• Product Code: JEY
• UDI-Device Identifier: 05420060380143
• UDI-Public: 05420060380143
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

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: SD980.014
• Device Catalogue Number: SD980.014
• Device Lot Number: ME24KEPUGE
• 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: 01/27/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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: 29 YR
• Patient Sex: Female