BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUNTER TORQUE

    MDR report key: 2496115 · Received March 8, 2012

    Report

    Report Number
    2032593-2012-00009
    Event Type
    Malfunction
    Date Received
    March 8, 2012
    Date of Event
    February 3, 2012
    Report Date
    March 8, 2012
    Manufacturer
    SEASPINE, INC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE SURGEON WAS USING THE COUNTER TORQUE FOR FINAL LOCKING OF THE SET SCREWS THE LOCKING DRIVER BEGAN TO STRIP OUT. THE SURGEON THEN REPOSITIONED THE COUNTER TORQUE AND TRIED TO LOCK DOWN THE SET SCREWS AGAIN AND THEN THE COUNTER TORQUE BROKE AT THE END THAT WAS SITTING OVER THE SET SCREW. THERE WAS NO DELAY IN SURGERY, THE SURGEON USED A 4MM MANUAL DRIVER TO FREEHAND TIGHTEN THE SET SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COUNTER TORQUE MALIBU LXH SEASPINE, INC K16371C

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR