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

Model Number	SD980.109
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	10/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
We have received feedback from surgeon about the exposed trumatch cmf implant.The surgeon placed the implant and packed it with particulated bone.At the 2 weeks post-op consultation the healing was going well, but by week 3.5-4 there was a fistulation on the floor of the mouth.Another surgery is planned as a redo surgery for which the patient will be implanted with a standard plate; the patient will be operated on (b)(6) 2022.
Event or Problem Description
We have received feedback from surgeon about the exposed trumatch cmf implant.The surgeon placed the implant and packed it with particulate bone.At the 2 weeks post-op consultation the healing was going well, but by week 3.5-4 there was a fistulation on the floor of the mouth.Another surgery is planned as a redo surgery for which the patient will be implanted with a standard plate; the patient will be operated on (b)(6) 2022.
Additional Manufacturer Narrative
Investigation concluded that the device met all specifications and did not malfunction.No root cause could be established for the fistulation in patient's mouth.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - 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: 16090978
• Report Number: 3003998208-2023-00001
• Device Sequence Number: 6639622
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: ME22QOJJEQ
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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: 85 YR
• Patient Sex: Female