BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1831041 · Received September 7, 2010

    Report

    Report Number
    1030489-2010-01136
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    October 7, 2005
    Report Date
    August 16, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (PSEUDARTHROSIS) - (B)(4). LITERATURE CITATION: PRADHAN ET AL. GRAFT RESORPTION WITH THE USE OF BONE MORPHOGENETIC PROTEIN: LESSONS FROM ANTERIOR LUMBAR INTERBODY FUSION USING FEMORAL RING ALLOGRAFTS AND RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2. SPINE. 2006; VOLUME 31: NUMBER 31: NUMBER 10, PP E277-E28. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADD'L DEVICE INFO. NEITHER THE DEVICE NOR IMAGING FILMS WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RADIOGRAPHS SHOWED EVIDENCE OF NONUNION. THE PATIENT WITH SINGLE-LEVEL DEGENERATIVE DISEASE AND LOW BACK PAIN FOR AT LEAST SIX MONTHS HAD NOT RESPONDED TO CONSERVATIVE MANAGEMENT. AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WAS PERFORMED USING A STAND-ALONE FEMORAL RING ALLOGRAPH (FRA) PACKED WITH RHBMP-2 SOAKED ABSORBABLE COLLAGEN SPONGES. THE FRA WAS PLACED INTO THE INTERVERTEBRAL SPACE. BETWEEN NINE AND TWELVE MONTHS POST SURGERY, RADIOGRAPHS ON THIS PT REVEALED NONUNION AT L5-S1. EVIDENCE OF NONUNION WAS ALSO CONFIRMED DURING SUBSEQUENT SURGICAL EXPLORATION AND SALVAGE POSTERIOR FUSION. NO OTHER DETAILS WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization