BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4195839 · Received October 23, 2014

    Report

    Report Number
    1030489-2014-04109
    Event Type
    Injury
    Date Received
    October 23, 2014
    Report Date
    September 24, 2014
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    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 # 8699090, 510K # K981676 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 SPINAL SURGICAL PROCEDURE AT L3-5. SOMETIME POST-OP, A REVISION SURGERY WAS PERFORMED DUE TO ADJACENT SEGMENT DISORDER. THE REVISION SURGERY WAS INITIALLY INTENDED TO EXTEND THE FUSION TO L1 USING DOMINOES. HOWEVER, ROD BREAKAGE WAS FOUND DURING THE SURGERY AT THE RIGHT L4/5, AND THE PROCEDURE WAS EVENTUALLY CHANGED TO ROD EXCHANGE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676970 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR SCREWS