BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2850406 · Received November 29, 2012

    Report

    Report Number
    1030489-2012-02470
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 4, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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-S1 TO TREAT DEGENERATIVE DISC DISEASE, SUBLUXATION AND STENOSIS. SOMETIME POST-OP, THE PATIENT'S LEG HAD GIVEN OUT AND THE PATIENT "HAD A FEW FALLS." THE PATIENT WAS SEEN FOR FOLLOW UP; OFFICE NOTES INDICATED X-RAY REVEALED THAT THE SCREW AT SI WAS BROKEN. THE DEVICE WAS EXPLANTED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H06F2491

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Required Intervention RODS, SCREWS