BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3866250 · Received June 11, 2014

    Report

    Report Number
    1030489-2014-02735
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 14, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    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 # 1556000500, 510K # K111942 WAS CLEARED IN THE UNITED STATES. THE DEVICE WAS NOT RETURNED HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: AP AND LATERAL X-RAYS OF COMPLEX CONSTRUCT LUMBAR AND ACROSS LS JUNCTION IS SHOWN TO INCLUDE ILIAC SCREWS. THESE VERIFY A BROKEN ILIAC SCREW ON THE RIGHT AS WELL AS A BROKEN ROD ON THE LEFT. PLIF SPACERS ARE VERIFIED IN ALL VISIBLE DISC SPACES UP TO L2/3. THE UPPER END OF THE CONSTRUCT CANNOT BE SEEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LUMBAR INTERBODY FUSION AT T10-ILIAC. 9 MONTHS POST-OP IT WAS FOUND THAT THE LEFT ROD WAS BROKEN AT L5. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN ROD AND A SCREW AT THE SACROILIAC JOINT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345872 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0262317W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BONE SCREW, SET SCREW