BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3294812 · Received August 19, 2013

    Report

    Report Number
    1030489-2013-03589
    Event Type
    Injury
    Date Received
    August 19, 2013
    Date of Event
    April 30, 2013
    Report Date
    July 21, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 # 869-021, 510K # K040962 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 T5-9. IT WAS REPORTED THAT SOMETIME POST-OP IT WAS FOUND THAT THE RIGHT T8 SCREW WAS FRACTURED AS WELL AS THE ROD. RECURRENCE OF TUMOR AT T8 WHICH CAUSED THE PATIENT PARALYSIS AND PAIN WAS REPORTED. A REVISION SURGERY WAS PERFORMED TO ADD ¿TES¿ AT T7, 8 <(>&<)> 9 AND SCREWS AT T10 <(>&<)> 11. TWO LP CROSSLINKS WERE ADDED TO THE CONSTRUCT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400892 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention