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

Model Number SD980.108

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Difficulty Chewing (4522)

Event Date 12/10/2020

Event Type  Injury  

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 Description

Mandible implant wore through patient's skin and was partially removed.Remainder of implant planned to be removed.

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
• Type of Device: 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
• MDR Text Key: 298023641
• Report Number: 3003998208-2022-00018
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060381089
• UDI-Public: 05420060381089
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male