BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3535735 · Received December 24, 2013

    Report

    Report Number
    1030489-2013-05175
    Event Type
    Injury
    Date Received
    December 24, 2013
    Date of Event
    September 1, 2013
    Report Date
    December 2, 2013
    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 #1475001080, 510K # K091974 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 LUMBAR FUSION AT L3-5. IT WAS REPORTED THAT THE RODS WERE FOUND BROKEN APPROXIMATELY 1 MONTH POST-OP. THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 2 MONTHS POST-OP. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674470 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0169864W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention