BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2982762 · Received February 28, 2013

    Report

    Report Number
    1030489-2013-00645
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 REVISION OF AN ORIGINAL CONSTRUCT OF L3-S1 TO EXTEND UP ONE LEVEL TO L2. IT WAS REPORTED THAT THE SET SCREW BACKED OUT SOMETIME POST-OP. THE PATIENT UNDERWENT A REVISION IN WHICH ALL HARDWARE WAS REMOVED AND A NEW CONSTRUCT WAS IMPLANTED AT T10-L3. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85626 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention