BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY POSTERIOR SPINAL SYSTEM

    MDR report key: 3963127 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03320
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 30, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 814-178T, 510K # K951164 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBER INTERBODY FUSION AND POSTERIOR SPINAL FUSION AT THE THORACIC SPINE TO THE ILIAC. DURING A REVISION TO CORRECT A MIGRATED HOOK IT WAS FOUND THAT THE CONNECTOR WAS BROKEN. THE PROBLEM WAS CORRECTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440951 LIBERTY POSTERIOR SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W05E2202

    Patients

    Seq Age Sex Outcome Treatment
    1