BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2001156 · Received February 24, 2011

    Report

    Report Number
    1030489-2011-00197
    Event Type
    Injury
    Date Received
    February 24, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A L4-S1 TLIF USING POSTERIOR FIXATION, AND INTERBODY DEVICE, AND RHBMP-2/ACS. THE PATIENT HAS HEALED THE INCISION WITHOUT INFLAMMATION AND NO GENERALIZED FEVER, BUT HAS DEVELOPED LOW BACK PAIN THAT IS MORE THAN USUAL, BILATERAL GROIN SYMPTOMS, AND BILATERAL PEDAL PARESTHESIAS. IMAGING SHOWS A 1.7 CM CYST EMANATING BEHIND THE INTERBODY DEVICE EXTENDING TO THE RIGHT FORAMEN. NO LAB TESTS HAVE BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention