BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM ALLTHREAD TI III ANCHOR

    MDR report key: 1905820 · Received November 22, 2010

    Report

    Report Number
    MW5018259
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BIOMET
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 5.0 ANCHORS (#1 AND #2) BROKE WHILE SURGEON WAS SCREWING THEM IN. THE 6.5 ANCHOR (#3) HANDLE BROKE AT THE AREA WHERE THE PLASTIC HANDLE MEETS THE POLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM ALLTHREAD TI III ANCHOR NONE MBI BIOMET 902612 648480
    2 5.0MM ALLTHREAD TI III ANCHOR NONE MBI BIOMET 902612 314890
    3 6.5 MM ALLTHREAD TI III ANCHOR NONE MBI BIOMET 902613C 680570

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR