MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI

Model Number	ME23GUNKUN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The surgeon has reported that a patient was developing a granuloma on the mandible post-operatively after the use of materialise personalized plate.
Event or Problem Description
The surgeon has reported that a patient was developing a granuloma on the mandible post-operatively after the use of materialise personalized plate.
Additional Manufacturer Narrative
The investigation concluded that the device met specifications.The exact reason why a granuloma appeared on patient's mandible could not be established.

• Brand Name: TRUMATCH
• Common Device Name: TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• 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: 20351659
• Report Number: 3003998208-2024-00018
• Device Sequence Number: 12758228
• Product Code: JEY
• UDI-Device Identifier: 05420060380167
• UDI-Public: 05420060380167
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/02/2024

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: ME23GUNKUN
• Device Catalogue Number: ME23GUNKUN
• Device Lot Number: SD980.016
• 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: 02/09/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2025
• 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: 19 YR
• Patient Sex: Male