EXODONTIA ELEVR #46R SERRATED
Received Dec 30, 2025
Report 0001032347-2025-00485 · MDR key 23922662
Device
Generic name
Elevator, Surgical, Dental
Manufacturer
Biomet MicrofixationCatalog number
09-0252
Lot number
B15
Product problems
- Fracture
- Fracture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE HAS NOT BEEN 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 THE ELEVATOR FRACTURED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: B5, D4, D9, G3, H1, H2, H4, AND H11. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. COMPLAINT CAN BE CONFIRMED THROUGH THE RETURNED PRODUCT ANALYSIS. FOR BOTH INSTRUMENTS THE COMPLAINTS ARE CONFIRMED. A VISUAL INSPECTION WAS CONDUCTED ON THE 09-0252 ELEVATOR LOT B15. THE INSTRUMENT SHOW SIGNS OF MULTIPLE USES WITH VERY HEAVY MARKING AND SCRATCHING ON THE INSTRUMENT SURFACE. THE TIP OF THE ELEVATOR HAS FRACTURED. THE FRACTURED TIP WAS NOT RETURNED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE TIP TO FRACTURE. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS PRODUCT HAS APPROXIMATE FIELD AGES OF 10 YEARS, WITH AN UNKNOWN NUMBER OF USES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.