BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1914215 · Received December 3, 2010

    Report

    Report Number
    1030489-2010-01536
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    June 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K043151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE CATALOG# 7191740, AND CATALOG# 7191650. NEITHER THE DEVICE NOR APPLICABLE TEST RESULTS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED SPINAL FUSION PROCEDURE USING POSTERIOR FIXATION. APPROXIMATELY FIVE MONTHS POST-OP, THE PATIENT IS REPORTING AN INCREASED ASTHMA LEVEL SINCE THE SURGERY. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL THAT THE PATIENT IS NOW ASYMPTOMATIC, AND HAS NOT REPORTED ANY DIFFICULTIES WITH ASTHMA OR ANY OTHER SYMPTOMS POST-OP. IT HAS BEEN REPORTED THAT THIS PATIENT HAD AN L4-S1 ARTHRODESIS WITH TLIF PERFORMED APPROXIMATELY A YEAR PRIOR TO THE REPORTED SURGERY. THIS SURGERY WAS FOLLOWED BY AND INFECTION REQUIRING WOUND REVISION, AND THEN ANOTHER SURGERY TO REPLACE THE HARDWARE AND FLUSH THE SITE AGAIN. THE IDENTITY OF THE DEVICES USED IN THESE THREE PRIOR SURGERIES IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Other