BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANE PICK ELEVATOR

    MDR report key: 21155026 · Received January 14, 2025

    Report

    Report Number
    0001032347-2025-00014
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Report Date
    May 9, 2025
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841036028237
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: D4, D9. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10, G3, G6, H2, H3, H4, H6, H10, H11. D10: ELEVATOR #0 CAT# 09-0258 LOT#D15. ELEVATOR #0 CAT# 09-0258 LOT#L12. ELEVATOR #0 CAT# 09-0258 LOT#C13. CRANE PICK ELEVATOR CAT# 09-0262 LOT# 00376350. FOR THE REPORTED TWO 09-0262 LOTS 00376350 NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. ITEM# 09-0262 LOT# 00376350- REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A SUPPLIER DHR REVIEW WAS NOT REQUESTED AS THE INSTRUMENT HAS AN ESTIMATED FIELD AGE OF THREE YEARS OF USE. PRODUCT WAS 100% INSPECTED AND THERE WERE NO VISUAL ANOMALIES. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ITEM# 09-0262 LOT# 00376350- THE REPORTED EVENT IS UNCONFIRMED. 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.

    Description of Event or Problem · 0

    IT IS REPORTED THAT THE ELEVATOR FRACTURED DURING A PROCEDURE.

    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
    1486477 CRANE PICK ELEVATOR ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 00376350 00841036028237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11