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

Model Number	SD980.016
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hardware was removed from the patient due to his allergy to metal.
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem Description
Hardware was removed from the patient due to his allergy to metal.
Additional Manufacturer Narrative
The investigation concluded that the devices met specifications and did not malfunction.The event is attributed to the patient's allergy.
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
Hardware was removed from the patient due to his allergy to metal.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer (Section G): MATERIALISE USA, LLC; 44650 helm court; plymouth MI 48170
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170
• MDR Report Key: 18373693
• Report Number: 3005718816-2023-00004
• Device Sequence Number: 15395186
• Product Code: JEY
• UDI-Device Identifier: 05420060380167
• UDI-Public: 05420060380167
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/06/2023

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: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: MU23OHOXIF
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 12/06/2023; 12/06/2023
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/18/2024; 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/28/2023
• 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: 30 YR
• Patient Sex: Male