BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 2671686 · Received July 26, 2012

    Report

    Report Number
    1030489-2012-01272
    Event Type
    Injury
    Date Received
    July 26, 2012
    Report Date
    June 29, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL FUSION PROCEDURE USING RHBMP-2. THE PATIENT HAS HAD ELEVATED CRP LEVELS AND INFLAMMATION SINCE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other