BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINPLATE 14MM 31X24MM

    MDR report key: 2443431 · Received January 25, 2012

    Report

    Report Number
    3008657535-2012-00007
    Event Type
    Malfunction
    Date Received
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    THEKEN SPINE, LLC
    Product Code
    OVD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PARTS WERE NOT RETURNED FOR EVALUATION, THEY WERE IMPLANTED IN THE PT AND CAUSED NO HARM. NO NONCONFORMITIES NOTED BASED ON A REVIEW OF THE DEVICE HISTORY RECORD. GIVEN THE DESCRIPTION OF THE EVENT AND THE OBSERVATIONS MADE DURING THE INVESTIGATION, THE ROOT CAUSE CANNOT BE DETERMINED. 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

    THE SURGEON COULD NOT GET THE SPIN PLATE TO FULLY LOCK IN THE ENGAGED POSITION. THE PARTS WERE IMPLANTED IN THE PT AND CAUSED NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINPLATE 14MM 31X24MM VU-APOD OVD THEKEN SPINE, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1