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

Model Number	SD980.108
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device met specifications.Removal surgery planned for (b)(6) 2022.Would not provide additional information as it was cut into pieces and parts are not explanted yet.
Event or Problem Description
Mandible implant wore through patient's skin and was partially removed.Remainder of implant planned to be removed.
Additional Manufacturer Narrative
Device met specifications.Removal surgery planned for 12 october 2022.H3: would not provide additional information as it was cut into pieces and parts are not explanted yet.Additional information received on 12 october 2022: removal surgery occurred on (b)(6) 2022, where the surgeon identified that a failed cadaveric graft was the root cause.No issues with the devices.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED IMPLANT FOR MANDIBLE, MEDIUM
• 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: 15238846
• Report Number: 3003998208-2022-00018
• Device Sequence Number: 4899763
• Product Code: JEY
• UDI-Device Identifier: 05420060381089
• UDI-Public: 05420060381089
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173039
• 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): 07/28/2022

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: SD980.108
• Device Catalogue Number: SD980.108
• Device Lot Number: MU20VUXDUG
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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: 63 YR
• Patient Sex: Male