BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1140685 · Received August 28, 2008

    Report

    Report Number
    1030489-2008-00462
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Report Date
    July 29, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED; THEREFORE, PRODUCT EVALUATION IS NOT POSSIBLE AT THIS TIME. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A ROD FRACTURE APPROXIMATELY 5 MONTHS POST-OP, BUT WAS NOT SYMPTOMATIC AT THE TIME. PATIENT RECENTLY BEGAN COMPLAINING OF PAIN AND VISITED THE SURGEON FOR X-RAYS/MRI AND TO DISCUSS IMPLANT REMOVAL. THE PATIENT IS REPORTEDLY SCHEDULED TO UNDERGO SURGERY FOR IMPLANT REMOVAL IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON AGILE SPINAL SYSTEM NQP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR