BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ASSEMBLY

    MDR report key: 2479226 · Received February 24, 2012

    Report

    Report Number
    3008657535-2012-00018
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    KWP
    PMA / PMN Number
    K070638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY SHOWED NO ANOMALIES. FROM THE PHYSICAL EVIDENCE THE LOCKING SCREW WAS USED TO PERSUADE THE ROD INTO PLACE CAUSING THE THREAD DAMAGE TO THE SCREW. THE LOCKING SCREW IS NOT TO BE USED TO PERSUADE THE ROD INTO PLACE. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED INTEGRA CONSIDERS THIS COMPLAINT INVESTIGATION CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED AS THE SURGEON WAS ENGAGING THE LOCKING CAP THE THREADING SHEARED OFF. THE SURGEON USED ANOTHER LOCKING CAP TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW ASSEMBLY ATOLL KWP THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1