BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3645585 · Received February 25, 2014

    Report

    Report Number
    1030489-2014-00569
    Event Type
    Injury
    Date Received
    February 25, 2014
    Date of Event
    February 6, 2014
    Report Date
    February 6, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    Adverse Event
    Yes
    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 # 5440030, 510K # K102555 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 POSTERIOR SPINAL SURGICAL PROCEDURE AT L3-4 WITH L3 SPONDYLOSIS. APPROXIMATELY 14 MONTHS POST-OP IT WAS REPORTED THAT PATIENT WAS HOSPITALIZED FOR A PREOPERATIVELY SCHEDULED REMOVAL SURGERY. IT WAS FOUND ON FILMS THAT THE ROD DISPLACED DUE TO SET SCREWS NOT BEING TIGHTENED PROPERLY WHICH IS EVIDENT BECAUSE OF THE BREAK OFF SCREWS NOT BEING BROKEN OFF. THE PATIENT UNDERWENT A REVISION SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115331 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H12K1660

    Patients

    Seq Age Sex Outcome Treatment
    1 00016 YR Required Intervention RODS