InjuryLZD
45MM LFT STANDARD MAND
Received Jul 20, 2026 · Event occurred Jan 5, 2026
Report 0001032347-2026-00215 · MDR key 25874763
Device
Generic name
Joint, Temporomandibular, Implant
Manufacturer
Biomet MicrofixationCatalog number
24-6546
Lot number
121350D
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
Narrative
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.
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.