BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2714280 · Received August 24, 2012

    Report

    Report Number
    1030489-2012-01497
    Event Type
    Injury
    Date Received
    August 24, 2012
    Report Date
    July 27, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PMA # P000058 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE USING RHBMP-2/ACS, AN INTERBODY CAGE AND SCREWS. SEVERAL MONTHS POST-OPERATIVELY, THE PATIENT WAS EXPERIENCING PAIN. RADIOGRAPHS DEMONSTRATED OSTEOLYSIS. A REVISION SURGERY WAS SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INTERBODY CAGE AND SCREWS