BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4876230 · Received June 29, 2015

    Report

    Report Number
    1030489-2015-01320
    Event Type
    Injury
    Date Received
    June 29, 2015
    Report Date
    June 2, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2007 THE PATIENT UNDERWENT A FUSION PROCEDURE IN WHICH RHBMP-2/ACS, VITOSS FOAM STRIP, DORAL GRAFT MATRIX FROM INTEGRA LIFE SCIENCES CORPORATION, RADIOPAQUE BONE CEMENT FROM STRYKER, FCAN 30 FROM LIFENET, TISSUE FROM MUSCULOSKELETAL TRANSPLANT FOUNDATION, AND SCREWS, SET SCREWS, RODS AND CROSSLINKS FROM BLACKSTONE MEDICAL WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417680 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M115008AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other