BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3261672 · Received August 2, 2013

    Report

    Report Number
    1030489-2013-03177
    Event Type
    Injury
    Date Received
    August 2, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    K052747
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 MINIMALLY INVASIVE POSTERIOR SURGICAL PROCEDURE TO TREAT A FRACTURE AT T10. 6 LEVELS WERE INSTRUMENTED WITH TWO LEVELS IN BETWEEN WITHOUT INSTRUMENTATION. IT WAS REPORTED THAT THE TOP AND BOTTOM SLEEVES RELEASED FROM THE SCREWS WHILE THREADING THE ROD THROUGH THE SLEEVES. A SMALL INCISION WAS MADE IN ATTEMPT TO GET A BEALE REDUCER ON THE SCREW. THE SURGEON WAS ABLE TO GET SEQUENTIAL REDUCTERS ATTACHED TO FINISH THE SURGERY. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363537 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SCREW