BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1961953 · Received January 15, 2011

    Report

    Report Number
    1030489-2011-00050
    Event Type
    Injury
    Date Received
    January 15, 2011
    Report Date
    December 18, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ARGINTAR E, ET AL. "BONE MORPHOGENETIC PROTEINS IN ORTHOPAEDIC TRAUMA SURGERY." INJURY (2010). (B)(4): (NON-UNION). A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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

    POST-OPERATIVE COMPLICATIONS WERE NOTED DURING CLINICAL AND RADIOGRAPHIC REVIEW OF HUMERAL NON-UNION FRACTURES TREATED WITH BONE MORPHOGENETIC PROTEINS AND FIXATION REVISION. FOUR PATIENTS DID NOT ACHIEVE UNION. FACTORS ASSOCIATED WITH FAILURE OF UNION WITH WERE LARGE BONY DEFECTS (GREATER THAN 4 CM) AND POOR SOFT-TISSUE VASCULARITY SURROUNDING THE NONUNION SITE. NO ADDITIONAL DETAILS WERE PROVIDED.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1