BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3920210 · Received July 8, 2014

    Report

    Report Number
    1030489-2014-03128
    Event Type
    Injury
    Date Received
    July 8, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397247 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 Other