BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATOR #0

    MDR report key: 9702437 · Received February 12, 2020

    Report

    Report Number
    0001032347-2020-00100
    Event Type
    Malfunction
    Date Received
    February 12, 2020
    Report Date
    April 3, 2020
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    EMJ
    UDI-DI
    00841036028190
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONFIRMED. THE ELEVATOR #0 (09-0258 LOT NUMBER: 032613C13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION SHOWED SIGNS OF USE AS THERE WAS MINOR SCRATCHING ON THE BODY OF THE ELEVATOR AND THE TIP HAD FRACTURED OFF. THE NON-CONFORMANCE DATABASE WAS REVIEWED FOR THIS PRODUCT; NO NON-CONFORMANCES WERE FOUND. FOR THIS PART (09-0258) AND THE PREVIOUS ONE YEAR (FROM THE NOTIFICATION DATE) REGARDING THE ELEVATOR FRACTURING, (B)(4).

    Description of Event or Problem · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). THE PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSTRUMENT FRACTURED DURING SURGERY. THE FRACTURED PIECE OF THE INSTRUMENT WAS REMOVED FROM THE PATIENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162437 ELEVATOR #0 ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION N/A 032613C13 00841036028190

    Patients

    Seq Age Sex Outcome Treatment
    1