BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE OPEN POLY SCREW 4.5 MM X 25 MM

    MDR report key: 1133461 · Received August 22, 2008

    Report

    Report Number
    1649384-2008-00452
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DID NOT OCCUR IN SURGERY. REQUEST HAS BEEN MADE FOR THE RETURN OF THE PRODUCT. REQUEST HAS BEEN MADE TO OBTAIN THE PRODUCT. EVALUATION PENDING UPON THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT UPON RECEIPT OF SHIPMENT, THE SCREW WAS FOUND DISASSEMBLED. THE MALFUNCTION, DISASSEMBLED, OF A SIMILAR DEVICE HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE OPEN POLY SCREW 4.5 MM X 25 MM NEXLINK KWP ABBOTT SPINE 48JZ

    Patients

    Seq Age Sex Outcome Treatment
    1