MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - 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	Implant Pain (4561)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Mandibular implant has loosened and needs to be fixated again.
Additional Manufacturer Narrative
Device met specifications, screws not manufactured by materialise.Root cause is identified as the patient condition.Device still implanted.
Additional Manufacturer Narrative
Device met specifications, screws not manufactured by materialise.Root cause is identified as the patient condition.Surgeon believes the patient has an undiagnosed bone disease which is leading to impaired bone healing.Replacement surgery is planned for october 2022 (d6b).
Event or Problem Description
Both mandibular implants have loosened and will need to be replaced by new implants.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - 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: 14099138
• Report Number: 3003998208-2022-00008
• Device Sequence Number: 12355021
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/24/2022

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: SD980.108
• Device Catalogue Number: SD980.108
• Device Lot Number: ME21HORMOH
• 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: 03/24/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2022
• 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: 48 YR
• Patient Sex: Female