BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3092493 · Received May 3, 2013

    Report

    Report Number
    1030489-2013-01536
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    March 11, 2018
    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 APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. 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 A SPINAL SURGERY USING BMP. IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP-2/ACS WAS USED. AS PER OPERATIVE NOTES ¿TWO RODS WERE CONTOURED, LOCKED INTO PLACE. DECOMPRESSION WAS PERFORMED AND THEN AUTOGRAFT ALONG WITH BONE MORPHOGENIC PROTEIN AND DECORTICATED THROUGHOUT AND PLACED BONE IN THE POSTERIOR LATERAL GUTTERS ON THE RIGHT AND LEFT SIDE. SET SCREWS WERE SHEARED OFF. CLOSURE OF MULTIPLE LAYERS WITH ETHIBOND AND VICRYL AND A SMALL HEMOVAC DRAIN.¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194612 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