BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2182922 · Received July 28, 2011

    Report

    Report Number
    1030489-2011-00962
    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
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: HELGESON ET AL. ADJACENT VERTEBRAL BODY OSTEOLYSIS WITH BONE MORPHOGENETIC PROTEIN USE IN TRANSFORAMINAL LUMBAR INTERBODY FUSION. THE SPINE JOURNAL 2011; 11:507-510. (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 THE PATIENT UNDERWENT AN L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH RHBMP-2/ACS AND AN INTERBODY DEVICE. POST-OPERATIVELY, THE PATIENT DEVELOPED OSTEOLYSIS SEEN ON AXIAL, SAGITTAL, AND CORONAL COMPUTER TOMOGRAPHY SCANS PERFORMED AT 5 MONTHS. ADDITIONALLY, THERE WAS NO EVIDENCE OF BRIDGING BONE OR INTERBODY FUSION AT THIS TIME. AT THE MOST RECENT FOLLOW-UP, THERE WAS EVIDENCE OF POSTEROLATERAL FUSION. THE PATIENT REMAINS ASYMPTOMATIC.

    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 00048 YR