BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM POLYAXIAL SCREW-OPEN 6.5 X 55

    MDR report key: 1190826 · Received September 24, 2008

    Report

    Report Number
    1649384-2008-00485
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DID NOT OCCUR IN SURGERY. RESULTS OF DEVICE HISTORY RECORD REVIEW INDICATES PART MET SPECIFICATIONS. VISUAL INSPECTION FOUND THE PART TO BE DISASSEMBLED, AN ENGINEERING INVESTIGATION DETERMINED CAUSE IS RELATED TO THE ASSEMBLY PROCESS.

    Description of Event or Problem · 1

    IN 2008, THE SALES REPRESENTATIVE REPORTED THAT DURING A KIT INSPECTION, IT WAS IDENTIFIED THAT THE SHAFT CAME OFF THE POLYAXIAL HEAD. THE MALFUNCTION OF A SIMILAR PRODUCT HAS RESULTED IN AN ADVERSE EVENT IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM POLYAXIAL SCREW-OPEN 6.5 X 55 INCOMPASS KWQ ABBOTT SPINE 41EX

    Patients

    Seq Age Sex Outcome Treatment
    1