BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDDLE SCREW EXTENDER SLEEVE

    MDR report key: 1052070 · Received May 21, 2008

    Report

    Report Number
    1649384-2008-00271
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED DURING KIT INSPECTION. PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION IS PENDING, UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING A KIT INSPECTION, IT WAS NOTICED THAT THE EXTENDER SLEEVE DOES NOT ATTACH TO THE SCREW. THE MALFUNCTION HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDDLE SCREW EXTENDER SLEEVE PATHFINDER LXH ABBOTT SPINE 25WK

    Patients

    Seq Age Sex Outcome Treatment
    1