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

Model Number SD980.021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Tears (2516)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.

Event Description

Patients skin flap on the mandible was very thin due to tumour proximity.She has now developed a hole in her skin over the left "bulge" of the implant.A skin graph will be placed during a next surgery.

Manufacturer Narrative

The implant's production records have been investigated and no issues were found.B3: correction made as the date of event was not correct.

• Brand Name: TRUMATCH
• Type of Device: MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, LARGE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 11160581
• MDR Text Key: 226558720
• Report Number: 3003998208-2021-00002
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380211
• UDI-Public: 05420060380211
• Combination Product (y/n): N
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: SD980.021
• Device Catalogue Number: SD980.021
• Device Lot Number: ME20HUQTAN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other