BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 2232610 · Received September 2, 2011

    Report

    Report Number
    1030489-2011-01130
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 22, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 ON A MEDWATCH FORM THAT A NEUROSURGERY PATIENT WAS SEEN FOR AN ANNUAL FOLLOWUP FOR AN L3-L5 POSTERIOR FUSION WITH VERTEBRAL BODY REPLACEMENTS. SUBSEQUENT X-RAY NOTED THAT THERE IS A CRACK IN ONE OF THE BOTTOM SCREWS AT THE POSTERIOR ASPECT OF THE PEDICLE. THIS WAS A NEW FINDING COMPARED TO PREVIOUS XRAYS. THE IMPLANT IS IN GOOD POSITION; REPORTEDLY, THERE IS NO NEED FOR REMOVAL AT THIS TIME. MOST RECENT XRAYS CONFIM PROPER ALIGNMENT HAS BEEN MAINTAINED AND SCREW POSITION UNCHANGED. PATIENT REPORTED PAIN CORRESPONDING TO WEATHER CHANGES SINCE LEARNING OF THE BROKEN SCREW. NO PAIN REPORTED PRIOR TO THE DISCOVERY. TREATMENT PROVIDED: PHYSICAL THERAPY FOR PROBABLE ACUTE SACROILIAC DYSFUNCTION OR SACROILIAC INFLAMMATORY PROCESS OR ARTHRITIS. 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 MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR ROD, VB REPLACEMENT