BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3121895 · Received May 21, 2013

    Report

    Report Number
    1030489-2013-01794
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 6, 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)(6). (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

    THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE WITH THE USE OF RHBMP-2. IT WAS REPORTED THAT THE PATIENT ALLEGEDLY SUSTAINED UNSPECIFIED INJURIES RESULTING FROM THE PROCEDURE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    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 ¿PRIOR TO INSERTION OF THE BOOMERANG GRAFT, AUTOGRAFT, WHICH WAS STRIPPED OF SOFT TISSUE WAS INSERTED FOR INTERBODY FUSION ALONG WITH BMP-2 PROTEIN. HALF OF THE ALLOGRAFT BONE AND AUTOGRAFT BONE WAS THEN PLACED IN THE LATERAL GUTTERS OVER THE TRANSVERSE PROCESS OF FACET JUNCTION ALONG WITH OSTEOFIL: NEXT THE DEVICE WAS DISENGAGED AND REMOVED. THE WOUND AGAIN WAS COPIOUSLY IRRIGATED WITH ANTIBIOTIC SALINE PROTECTING THE OSTEOFIL AND BONE GRAFT WITH A SPONGE. THE REST OF THE AUTOGRAFT, AUTOGRAFT BONE, BMP-2 PROTEIN AND OSTEOFIL WERE PLACED IN THE LATERAL GUTTERS FOR FUSION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224690 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