BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3112254 · Received May 14, 2013

    Report

    Report Number
    1030489-2013-01698
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    December 29, 2017
    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
    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 THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP2/ACS WAS USED. AS PER OP-NOTES,¿ AFTER THE DISKECTOMY WAS PERFORMED THE WOUND WAS IRRIGATED COPIOUSLY ONCE AGAIN AND BONE GRAFT WAS PLACED. I PLACED ONE SPONGE OF BMP UP ANTERIORLY, THEN I PACKED GROUNDED UP BONE GRAFT FROM THE LAMINECTOMY BONE UP FROM ANTERIORLY AND PACKED IT IN. I PLACED TWO STRUCTURAL GRAFTS; THEY WERE NUVASIVE TRIAD GRAFTS MEASURING 10 MM IN HEIGHT. THEY WERE PLACED, ONE ON THE RIGHT AND ONE ON THE LEFT, THEN ADDITIONAL BONE GRAFT WAS PACKED IN BETWEEN THE GRAFTS.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212596 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other