BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL OCT SCREW 4.0MM X 10MM

    MDR report key: 2577972 · Received May 11, 2012

    Report

    Report Number
    1649384-2012-00046
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    March 23, 2012
    Report Date
    April 11, 2012
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING NEXLINK OCT SURGERY, FOUR CORTICAL OCCIPITAL SCREWS BROKE. THE BROKEN PORTION OF THE SCREWS REMAINED IN THE PT AND COULD NOT BE REMOVED. THEREFORE, ONLY 2 SCREWS WERE SUCCESSFULLY USED TO TIGHTEN DOWN THE PLATE AND COMPLETE THE CASE. THE PT'S BONE WAS REPORTED TO HAVE BEEN VERY HARD. IT ALSO WAS REPORTED THE SURGICAL TECHNIQUE WAS PROPERLY FOLLOWED. MINI TOOLS, DRILL AND CORTICAL TAP WERE USED. THE DELAY TO THE CASE WAS 16-30 MINUTES AND NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL OCT SCREW 4.0MM X 10MM CORTICAL OCT SCREW 4.0MM X 10MM KWP ABBOTT SPINE, INC. 7005-4010 56MW

    Patients

    Seq Age Sex Outcome Treatment
    1