BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE OPEN POLY SCREW 4.5MM X 25MM

    MDR report key: 1202124 · Received October 16, 2008

    Report

    Report Number
    1649384-2008-00528
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 19, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. PROD WAS NOT IMPLANTED. REQUESTS HAVE BEEN MADE FOR THE RETURN OF THE PRODUCT. EVALUATION IS PENDING UPON RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE REPORTED THAT UPON RECEIVING A SHIPMENT AT HIS OFFICE, FIVE NEXLINK SCREW HEADS WERE FOUND DISASSEMBLED. THE SAME MALFUNCTION OF A SIMILAR PRODUCT HAS RESULTED IN AN ADVERSE EVENT IN THE PAST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE OPEN POLY SCREW 4.5MM X 25MM NEXLINK KWP ABBOTT SPINE 38DD

    Patients

    Seq Age Sex Outcome Treatment
    1