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

Model Number SD980.109

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Migration (4003)

Patient Problem Wound Dehiscence (1154)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.

Event Description

Mandible implant was wearing through the patients soft tissue and was explanted.

Manufacturer Narrative

Suboptimal patient condition after previous surgery with standard implant and bad soft tissue condition of the patient are the root causes of the implant wearing through the patients soft tissue.H3: device was discarded at hospital.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED IMPLANT FOR MANDIBLE, LARGE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 11192717
• MDR Text Key: 227487882
• Report Number: 3003998208-2021-00003
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060381096
• UDI-Public: 05420060381096
• Combination Product (y/n): N
• PMA/PMN Number: K173039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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: MU20OXATEC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR