BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #301

    MDR report key: 13096196 · Received December 28, 2021

    Report

    Report Number
    0001032347-2021-00560
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Report Date
    March 10, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 09-0257, LOT # UNK, ELEVATOR #301, ITEM # 09-0257, LOT # UNK, ELEVATOR #301, ITEM # 09-0257, LOT # UNK, ELEVATOR #301, ITEM # 09-0257, LOT # UNK, ELEVATOR #301. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00558, 0001032347-2021-00559, 0001032347-2021-00561, 0001032347-2021-00562

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT WAS FOUND BROKEN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992808 ELEVATOR #301 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown