BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1893133 · Received October 29, 2010

    Report

    Report Number
    1030489-2010-01415
    Event Type
    Injury
    Date Received
    October 29, 2010
    Report Date
    October 1, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MFR FOR EVAL, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NON-UNION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL SURGERY WHICH INCLUDED A FORAMINOTOMY AND A PLATE WAS IMPLANTED. THE PT REPORTED THAT FUSION IS NOT OCCURRING AND THAT THE PT MAY HAVE AN ALLERGY TO THE METAL IN THE IMPLANT. THE PT IS RUNNING A LOW GRADE FEVER AND HAS AN ALLERGY TO TITANIUM AND COPPER. NO REVISION SURGERY HAS BEEN SCHEDULED. NO OTHER PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM PLATE KWQ MEDTRONIC SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other