BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2182918 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00963
    Event Type
    Injury
    Date Received
    July 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: HOWARD ET AL. POSTERIOR ILIAC CREST PAIN AFTER POSTEROLATERAL FUSION WITH OR WITHOUT ILIAC CREST GRAFT HARVEST. THE SPINE JOURNAL 2011; 11: 534-537. (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 IN A LITERATURE PUBLICATION THAT 59 PATIENTS UNDERWENT INSTRUMENTED POSTEROLATERAL FUSION DONE AT ONE TO TWO LEVELS FROM L1 TO S1. POSTOPERATIVELY, THE PATIENTS WERE EXAMINED FOR TENDERNESS OVER THE SURGICAL SITE AS WELL AS THE LEFT AND RIGHT POSTERIOR ILIAC CREST. PATIENTS WERE ASKED TO RATE THE INTENSITY OF THE PAIN ON A SCALE OF 1 TO 10 WITH 0 BEING NO PAIN AND 10 BEING THE WORST PAIN. FOUR PATIENTS REPORTED PAIN OVER THE LEFT POSTERIOR ILIAC CREST.

    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 USA, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other