BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2221401 · Received August 24, 2011

    Report

    Report Number
    1030489-2011-01096
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: MURTAGH ET AL. NEW TECHNIQUES IN LUMBAR SPINAL INSTRUMENTATION: WHAT THE RADIOLOGIST NEEDS TO KNOW. RADIOLOGY 2011; VOL 260: NUMBER 2. (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 A PATIENT UNDERWENT DISCECTOMY AND FUSION AT L3-4 TO L5-S1 USING RHBMP-2/ACS. PREOPERATIVE T2-WEIGHTEN IMAGE SHOWS L5-S1 DISK DESICCATION AND A DISK BULGE. POSTOPERATIVE SHORT INVERSION TIME INVERSION-RECOVERY IMAGE SHOWS EXTENSIVE T2 SIGNAL ABNORMALITY IN THE VERTEBRAL BODIES ALONG BOTH SIDES OF THE DISK SPACE. THIS APPEARANCE IS CONSISTENT WITH INFLAMMATION. ADDITIONAL, PREVERTEBRAL SOFT-TISSUE SWELLING AT L5-S1 WAS NOTED. IN THIS PATIENT, THE MR IMAGING FINDINGS WERE ATTRIBUTED TO BMP-INDUCED INFLAMMATORY CHANGES, GIVEN THE RECENT USE OF BMP AND THE ABSENCE OF CLINICAL FINDINGS OF INFECTION-LIKE ALTERATION IN WHITE BLOOD CELL COUNT, ERYTHROCYTE SEDIMENTATION RATE, AND C-REACTIVE PROTEIN LEVEL.

    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. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention