BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDDLE SCREW EXTENDER SLEEVE

    MDR report key: 1023465 · Received April 2, 2008

    Report

    Report Number
    1649384-2008-00172
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 7, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT THE EXTENDER SLEEVES WERE BEING TESTED AND THE SLEEVE WOULD NOT HOLD THE SCREWS PROPERLY. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST. THERE WAS NO REPORT OF CONTACT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDDLE SCREW EXTENDER SLEEVE PATHFINDER LXH ABBOTT SPINE, INC. 39BB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA