BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPOND REDUCTION SCREW

    MDR report key: 2602481 · Received May 31, 2012

    Report

    Report Number
    3005977257-2012-00007
    Event Type
    Other
    Date Received
    May 31, 2012
    Date of Event
    March 12, 2012
    Report Date
    May 31, 2012
    Manufacturer
    SPINEFRONTIER, INC.
    Product Code
    MRW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON DID NOT PLACE SCREW DEEP ENOUGH AND THEN TRIED REMOVING IT BY BACKING IT OUT USING A TOOL NOT INTENDED FOR THAT USE. THIS RESULTED IN BENDING OF THIS INSTRUMENT WHICH PREVENTED REMOVAL OF THE SCREW. SURGEON THEN TRIED USING A LOCKING DRIVER ASSEMBLY INSTRUMENT TO REMOVE THE SCREW WHICH RESULTED IN THE TIP OF THE DRIVER BREAKING. BROKEN TIP WAS REMOVED AND SURGEON WAS UNABLE TO SUCCESSFULLY REMOVE THE SCREW. NO HARM WAS DONE TO THE PT AND NO FOLLOW-UP TREATMENT WAS NECESSARY.

    Description of Event or Problem · 1

    SURGEON PUT IN AN 8.0X50MM RESPOND (REDUCTION SCREW) IN THE PT AND THEN REALIZED THAT HE DIDN'T GET THE SCREW PLACEMENT IN DEEP ENOUGH. SURGEON WAS UNABLE TO REMOVE THE SCREW AFTER SEVERAL ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPOND REDUCTION SCREW RESPOND REDUCTION SCREW MRW SPINEFRONTIER, INC. 8 DEGREE 50MM

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR