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

Model Number	SD980.021
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Difficulty Chewing (4522); Implant Pain (4561)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Mandible plate broke and needs to be replaced.
Additional Manufacturer Narrative
Investigation ongoing.Initial awareness of broken plate on (b)(6) 2021.Identified as reportable event on (b)(6) 2022.Device still implanted.
Additional Manufacturer Narrative
Device met specification.Surgeon did not place a graft as intended/planned which placed additional forces on the plate.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, LARGE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leueven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 14447353
• Report Number: 3003998208-2022-00011
• Device Sequence Number: 20421655
• Product Code: JEY
• UDI-Device Identifier: 05420060380211
• UDI-Public: 05420060380211
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: SD980.021
• Device Catalogue Number: SD980.021
• Device Lot Number: MU20HAHSEH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 11/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: 27 YR
• Patient Sex: Male