BEUDAMED
    FDA Adverse Event Death Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4213622 · Received October 30, 2014

    Report

    Report Number
    1030489-2014-04172
    Event Type
    Death
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. (B)(4). LOCATION : HOSPITAL. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 5441113, 510K # K091974 WAS CLEARED IN THE UNITED STATES. 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695081 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death SCREWS, RODS