BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIPTIGHT

    MDR report key: 3933948 · Received July 2, 2014

    Report

    Report Number
    3933948
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 8, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BIOMET, INC.
    Product Code
    MBI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN PLACED THE DEVICE WITH NO NOTED PROBLEMS. PATIENT CLAIMS THAT ONE WEEK AFTER THE SURGERY THE WIRE WAS DISCONNECTED AND THE TOE RETURNED TO ITS PRE-OPERATIVE POSTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385530 ZIPTIGHT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE MBI BIOMET, INC. * 385840

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR