BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1951189 · Received January 6, 2011

    Report

    Report Number
    1030489-2011-00009
    Event Type
    Injury
    Date Received
    January 6, 2011
    Report Date
    December 9, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: PATIL S. CLINICAL AND RADIOLOGICAL OUTOMES OF AXIAL LUMBAR INTERBODY FUSION. DOI: 10.3928/01477447-20 101021-05. (B)(4) - PSEUDOARTHROSIS. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE THAT THAT PATIENT UNDERWENT AN AXIAL LUMBAR INTERBODY FUSION. SOMETIME POST-OP THE PATIENT HAD PSE UDOARTHROSIS AT L5-S1 AND UNDERWENT A REVISION SURGERY WITH PEDICLE SCREWS AND ILIAC BOLTS. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention