BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2991337 · Received March 6, 2013

    Report

    Report Number
    1030489-2013-00693
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K031655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    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 THAT THE PATIENT UNDERWENT A POSTERIOR SURGICAL PROCEDURE AT L3-5 SKIPPING L4 DUE TO FRACTURE OF THE L4 VERTEBRAE. A PPROXIMATELY 3-4 YEARS POST-OP THE PATIENT BEGAN FEELING PAIN. AFTER AN MRI IT WAS NOTICED THAT THE SET SCREW WAS DISLODGED. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95526 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention