BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CURVED LENKE PROBE

    MDR report key: 2447007 · Received January 30, 2012

    Report

    Report Number
    3008657535-2012-00008
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVAL. A REVIEW OF THE DEVICE HISTORY SHOWED NO ANOMALIES. ROOT CAUSE ANALYSIS IS NOT POSSIBLE SINCE THERE IS NO PRODUCT RETURN. BASED ON THE REPORTED INFO AND THE INVESTIGATION RESULTS PROVIDED. INTEGRA CONSIDERS THIS COMPLAINT CLOSED. FUTURE INCIDENTS OF THIS NATURE WILL BE DOCUMENTED FOR RECURRENCE AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY, THE TIP BROKE OFF WHEN THE SURGEON WAS LEVERING THE PROBE. A SPARE PROBE WAS USED AND THE SURGERY WAS COMPLETED. THE REPORTER HAS NO OTHER INFO TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED CURVED LENKE PROBE CORAL KWP THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1