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

Model Number	SD980.108
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the production records highlighted that the implant met specifications.The personalized implant was planned with a screw configuration that took into account screw holes from previous surgeries.The implant was planned relatively close to the teeth neck per request of the surgeon, given the patient condition and taking into account screw holes from a previous surgery, which increases risk for infection.This is the probable cause of exposure of the implant.
Event or Problem Description
On 24th of january 2024 materialise was notified that a personalized mandible implant had exposure (coming out through the soft tissue), the screw became loose which resulted in implant positioning being slightly off in the interior part of the implant.The surgeon has requested a new implant.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH TITANIUM 3D PRINTED IMPLANT FOR MANDIBLE, MEDIUM
• 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: 18766256
• Report Number: 3003998208-2024-00003
• Device Sequence Number: 7627609
• Product Code: JEY
• UDI-Device Identifier: 05420060381089
• UDI-Public: 05420060381089
• 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: 2023
• 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): 01/24/2024

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: SD980.108
• Device Catalogue Number: SD980.108
• Device Lot Number: ME23ICEXUP
• 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: 01/24/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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: 48 YR
• Patient Sex: Male