MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH TI IMPLANT - MANDIBLE - LARGE

Model Number SD980.109

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2022

Event Type  Injury  

Event Description

Materialise was informed on (b)(6) 2023 that implant in the patient is broken somewhere on the canine level.

Manufacturer Narrative

Investigation ongoing; rc unknown.

Manufacturer Narrative

Investigation concluded that the device met specifications and did not malfunction.No clear root cause could be established for the implant breaking issue.However the graft did not regenerate as expected and the patient did not follow advised soft diet until the bone is stable, and these factors could have contributed to the breakage.

Event Description

Materialise was informed on (b)(6) 2023 that implant in the patient is broken somewhere on the canine level.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH TI IMPLANT - MANDIBLE - LARGE
• 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, vlaaams-brabant 3001 ; BE 3001
• MDR Report Key: 16553658
• MDR Text Key: 311403599
• Report Number: 3003998208-2023-00006
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 02/16/2023

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
• Device Operator: Health Professional
• Device Model Number: SD980.109
• Device Catalogue Number: SD980.109
• Device Lot Number: ME22NUNCUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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: 19 YR
• Patient Sex: Male