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

Model Number	SD980.016
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	11/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient is developing a granuloma on mandible right side, two months post surgery using materialise personalized plates.
Additional Manufacturer Narrative
Investigation ongoing; rc unknown.
Additional Manufacturer Narrative
The investigation concluded that the device did not malfunction and there was no deterioration in the characteristics of the performance of the device.Investigation showed that the device met specifications.The surgeon confirmed that a possible cause for granuloma could be a reaction of the body to the plate itself as a foreign object.The sterilization protocol used by the hospital could not be confirmed so it can't be excluded that it could have contributed to the issue as well as a possible post-operative care issues.The exact reason why a granuloma appeared on patient's mandible right side could not be established.
Event or Problem Description
A patient is developing a granuloma on mandible right side, two months post surgery using materialise personalized plates.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - 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: 18650209
• Report Number: 3003998208-2024-00004
• Device Sequence Number: 12559549
• 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: 2023
• 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): 01/29/2024

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: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: ME23GEFVIK
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: 22 YR
• Patient Sex: Female