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

Model Number	SD980.109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient rejected mandible implant which had to be removed.Implant rejection was caused by patient condition according to surgeon.
Additional Manufacturer Narrative
Implant rejection caused by patient condition according to surgeon.Root cause has already been determined.Return of implant would not lead to additional information.

• Brand Name: TRUMATCH
• Common Device Name: TITANIUM 3D PRINTED IMPLANT FOR 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, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 15326021
• Report Number: 3003998208-2022-00019
• Device Sequence Number: 20423400
• Product Code: JEY
• UDI-Device Identifier: 05420060381096
• UDI-Public: 05420060381096
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K173039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2022

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: SD980.109
• Device Catalogue Number: SD980.109
• Device Lot Number: ME21AXUQUC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male