inforMED
InjuryLZD

TMJ SM LFT FOSSA COMP

Received Jul 20, 2026 · Event occurred Jan 5, 2026

Report 0001032347-2026-00214 · MDR key 25874717

Device

Generic name

Joint, Temporomandibular, Implant

Catalog number

24-6563

Lot number

148770D

Product problems

  • Insufficient Device Problem Information

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TEMPOROMANDIBULAR JOINT (TMJ) PROCEDURE AND WAS SUBSEQUENTLY REVISED APPROXIMATELY 3 YEARS POST-IMPLANTATION FOR UNSPECIFIED REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). 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.