MAUDE Adverse Event Report: Biomet Microfixation TMJ SM LFT FOSSA COMP; Joint, Temporomandibular, Implant

Catalog Number	24-6563
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent a tmj procedure and was subsequently revised approximately 2 years and 8 months post-implantation for an unknown reason.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: 50mm lft narrow ti mand, cat#: 01-6551ti, lot#: 068160d.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: TMJ SM LFT FOSSA COMP
• Common Device Name: Joint, Temporomandibular, Implant
• Manufacturer (Section D): Biomet Microfixation; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): Biomet Microfixation; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50565917
• Report Number: 0001032347-2026-00264
• Device Sequence Number: 10533135
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)280131(10)161870D
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: Lay User/Patient
• Device Catalogue Number: 24-6563
• Device Lot Number: 161870D
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: see h11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown