BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2960828 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00466
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 16, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8699120, 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 TOTAL EN BLOC SPONDYLECTOMY AT T3-8. IT WAS REPORTED THAT WHILE DOING SIT-UPS DURING PE AT SCHOOL THE PATIENT HEARD A CRACKING SOUND. IT WAS FOUND OUT THAT THE ROD BROKE AT THE T7 SCREW. A REVISION SURGERY WAS PERFORMED 10 MONTHS POST-OP, THE RODS WERE REMOVED AND REPLACED WITH DIFFERENT RODS. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65539 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0123167W

    Patients

    Seq Age Sex Outcome Treatment
    1 00018 YR Required Intervention BONE SCREW