BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXODONTIA ELEVR #46R SERRATED

    MDR report key: 22782472 · Received August 12, 2025

    Report

    Report Number
    0001032347-2025-00343
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Report Date
    September 18, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841035028152
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: EXODONTIA ELEVR #46R, SERRATED CAT# 09-0252, LOT# 232758. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H4. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED ELEVATOR. THE RETURNED ELEVATOR SHOWS SIGNS OF MULTIPLE USES INCLUDING HEAVY MARKING AND SCRATCHING ON THE ELEVATOR SURFACE. FURTHER INSPECTION SHOWS THAT THE ELEVATOR HAS FRACTURED AT THE TIP. THE FRACTURED TIP WAS NOT RETURNED. THE COMPLAINT IS CONFIRMED. A DETERMINATION CANNOT BE MADE AS TO WHAT CAUSED THE ELEVATOR TO FRACTURE. A FRACTURE ANALYSIS WAS NOT CONDUCTED AS THE PRODUCT SHOWS SIGNS OF MULTIPLE USES AND WITH A FIELD AGE OF TWO YEARS. REVIEW OF THE DHR IDENTIFIED NO DEVIATIONS OR ANOMALIES A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED, BASED ON PROVIDED PHOTOS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4 : LOT #. D10: LOT #. THE FOLLOWING SECTIONS UPDATED: B4, B5, D4, D9, D10, G3, G6, H2, H4, H11. D10: EXODONTIA ELEVR #46R SERRATED, CAT# 09-0252, LOT# 00384284. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ELEVATOR WAS FRACTURED DURING A PROCEDURE. NO PATIENT HARM OR DELAY WAS REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339804 EXODONTIA ELEVR #46R SERRATED PERIOSTEAL ELEVATOR, REUSABLE EMJ BIOMET MICROFIXATION NI 00384284 00841035028152

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown