BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFEWIRE Y-WIRE

    MDR report key: 4277093 · Received November 19, 2014

    Report

    Report Number
    MW5039227
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 12, 2014
    Manufacturer
    SAFE WIRE, INC.
    Product Code
    HXI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE END OF THE WIRE BROKE OFF FLUSH IN THE S1 VERTEBRA. SURGEON WAS UNABLE TO REMOVE. THE REMAINDER OF THE WIRE WAS RETRIEVED. NO COMPLICATIONS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750314 SAFEWIRE Y-WIRE Y-WIRE HXI SAFE WIRE, INC. FC-140-22-B-2 82117787

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention