BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOGGLELOC FIXATION DEVICE WITH DOUBLE ZIPLOOP TECHNOLOGY

    MDR report key: 2132682 · Received June 13, 2011

    Report

    Report Number
    MW5021000
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    April 26, 2011
    Report Date
    June 13, 2011
    Manufacturer
    BIOMET SPORTS MEDICINE
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMET SPORTS MEDICINE INFORMED US THAT THEY REPORTED AN EVENT TO MEDWATCH. THE PT HAD A REVISION PROCEDURE DUE TO SYMPTOMS RETURNING. DISCOVERED TOP BUTTON ON DEVICE WAS LOOSE AND ONLY ONE ZIPLOOP PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOGGLELOC FIXATION DEVICE WITH DOUBLE ZIPLOOP TECHNOLOGY NONE MBI BIOMET SPORTS MEDICINE 904835 61300

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR