BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW DRIVER SHAFT

    MDR report key: 3243164 · Received July 18, 2013

    Report

    Report Number
    2032593-2013-00047
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    July 8, 2013
    Report Date
    July 18, 2013
    Manufacturer
    SEASPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SCREW DRIVER SHAFT BROKE OFF IN THE SCREW AS THE SCREW WAS EXPLANTED. THERE WAS NO DELAY IN SURGERY OR ADVERSE EFFECT REPORTED "BECAUSE WE WERE TAKING THAT SCREW OUT ANYWAY." A SPARE DEVICE WAS AVAILABLE THAT FUNCTIONED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335361 SCREW DRIVER SHAFT NEWPORT HXX SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1