BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3111047 · Received May 14, 2013

    Report

    Report Number
    1030489-2013-01682
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 SCOLIOSIS CORRECTION SURGICAL PROCEDURE AT T3-ILIAC USING COMPETITOR'S WIRES AT T3-12 AND RODS AND SCREWS AT L1-ILIAC. APPROXIMATELY 3 YEARS POST-OP THE PATIENT UNDERWENT A REVISION SURGERY BECAUSE THE ROD WAS CAUSING A BUMP IN THE BACK AFTER ALL THE COMPETITORS WIRES BROKE. THE SURGEON CUT THE ROD(S) AND REMOVED THORACIC PART. IN ADDITION, DECUBITUS CAUSED BY THE RIGHT ILIAC SCREW AND CONNECTOR WAS CONFIRMED; SO THAT, THE SCREW AND THE CONNECTOR WERE ALSO REMOVED. THE SURGEON COMMENTED THAT THE PATIENT MIGHT HAVE INFECTION AND THE IMPLANTS DID NOT HAVE ANY PROBLEMS. AN ADDITIONAL REVISION SURGERY TO EXTEND THE FIXATION IS UNDER CONSIDERATION AFTER THE PATIENT RECOVERS FROM INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211750 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Required Intervention