BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2962552 · Received February 14, 2013

    Report

    Report Number
    1030489-2013-00506
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    May 9, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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 THE PATIENT UNDERWENT AN UNSPECIFIED SURGERY USING RHBMP-2/ACS. POST-OP THE PATIENT DEVELOPED "SIGNIFICANT PAIN AND MAJOR PROBLEMS INCLUDING PAIN AND MENTAL ANGUISH. I'M WORRIED THINGS WILL GET WORSE."

    Description of Event or Problem · 1

    THE PATIENT WAS PRESENTED WITH FOLLOWING PRE-OP DIAGNOSIS: DEGENERATIVE DISC DISEASE, NEUROFORAMINAL STENOSIS. THE PATIENT UNDERWENT TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY AT L4-L5 IN WHICH RH-BMP2/ACS WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65933 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111064AAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other