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

Model Number SD980.109

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fistula (1862)

Event Date 10/13/2022

Event Type  Injury  

Event 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 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.

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
• 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
• 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
• MDR Text Key: 306565929
• Report Number: 3003998208-2023-00001
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060381096
• UDI-Public: 05420060381096
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K173039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: ME22QOJJEQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR
• Patient Sex: Female