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

Model Number	SD980.021
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	11/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003998208-2021-00002
• Device Sequence Number: 19813471
• Product Code: JEY
• UDI-Device Identifier: 05420060380211
• UDI-Public: 05420060380211
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: SD980.021
• Device Catalogue Number: SD980.021
• Device Lot Number: ME20HUQTAN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other