BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SYSTEM

    MDR report key: 272949 · Received March 24, 2000

    Report

    Report Number
    MW4002728
    Event Type
    Injury
    Date Received
    March 24, 2000
    Date of Event
    September 13, 1999
    Report Date
    March 20, 2000
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED DURING A SPINAL FUSION SURGERY AND SUBSEQUENTLY REMOVED DUE TO A DEFECT IN THE PRODUCT, I.E., SLIPPAGE DUE TO LOOSENING SCREWS. THE HARDWARE WAS RETURNED TO THE MFR FOR INVESTIGATION BY THEIR LABS, RATHER THAN THE PATHOLOGY DEPT OF HOSP. RPTR HAS BEEN TRYING UNSUCCESSFULLY FOR SIX MONTHS TO GET A REPORT ON THE ROD FROM THE MFR, AS PROMISED. IT IS RPTR'S UNDERSTANDING THAT IF THERE IS A SITUATION SUCH AS THIS, THE MFR MUST REPORT IT TO THE FDA. RPTR WOULD LIKE TO KNOW IF THE MFR SUBMITTED A REPORT AND TO GET A COPY OF ANY FILE. RPTR IS NOW IN CONSTANT PAIN FROM ANOTHER ROD THAT HADN'T BEEN REMOVED BUT IS NOW ALSO LOOSE. IT HAS BEEN RECOMMENDED TO RPTR THAT IT TOO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SYSTEM SPINAL FUSION HARDWARE KWP DANEK MEDICAL, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention