BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTCER

    MDR report key: 965200 · Received May 11, 2007

    Report

    Report Number
    1649384-2007-00038
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    February 14, 2007
    Report Date
    May 11, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS INVESTIGATED BY REVIEWING THE DEVICE HISTORY RECORDS, THE SHIPPING RECORDS AND PERFORMING A VISUAL INSPECTION OF THE RETURNED PRODUCT. THE RETURNED PRODUCT MET SPECFICATIONS WHEN SHIPPED ON 11/17/2006. AN EXAMINATION OF THE PLATE DETERMINED THE PLATE HAD BEEN TAMPERED WITH, THEREFORE, THE ISSUE IS RELATED TO MIS-HANDLING OF THE PRODUCT. A GLOBAL INVESTIGATION OF THIS ISSUE HAS BEEN PERFORMED. THE INVESTIGATION DETERMINED THAT IF THE PLATE IS TAMPERED WITH OR FORCED BEYOND ITS OPERATING RANGE THERE IS A POSSIBILITY OF FAILURE OF THE RATCHET FEATURE RESULTING IN PLATE DISSOCIATION. CORRECTIVE ACTION IS BEING IMPLEMENTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANTCER PLATE WAS RECEIVED BY A SALES REPRESENTATIVE THAT WOULD NOT ENGAGE. THE PLATE WAS RETURNED FOR ANALYSIS PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTCER 3 LEVEL 59M ANTCER PLATE KWQ ABBOTT SPINE, INC. NA 33WY

    Patients

    Seq Age Sex Outcome Treatment
    1 *