BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING SCREW ASSEMBLY

    MDR report key: 2480492 · Received February 22, 2012

    Report

    Report Number
    3008657535-2012-00016
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Report Date
    February 22, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    MNI
    PMA / PMN Number
    K070962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY SHOWED NO ANOMALIES. ROOT CAUSE ANALYSIS IS NOT POSSIBLE DUE TO PARTS NOT RETURNED. 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 THE BRIDLE OF THE LOCKING CAP BROKE OVER THE OPEN INCISION DURING THE SURGERY. THERE WAS NO HARM TO THE PT TO REPORT. THE POST OPERATIVE X-RAY WAS NEGATIVE FOR FOREIGN BODIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW ASSEMBLY CORAL MNI THEKEN SPINE, LLC W16026

    Patients

    Seq Age Sex Outcome Treatment
    1