BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163426 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02215
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    January 26, 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 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, ¿SPINOLOGY CAGE OF THE APPROPRIATE SIZE WAS SELECTED FOR THE L4-5 AND L5-S1 DISC SPACE. THESE WERE PLACED ON THE CAGE INSERTION DEVICE AND THE #8 WOLF TUBES ON THE RIGHT SIDE WERE EXCHANGED FOR THE SPINOLOGY TUBES, THESE WERE ATTACHED TO THE TABLE MOUNT. THE CAGE WAS PLACED INTO THE L4-5 DISC SPACE. PRIOR TO PLACING THE CAGE, ILIAC CREST BONE AND LOCAL AUTOGRAFT BONE MIXED WITH BMP WERE PLACED INTO THE ANTERIOR MOST ASPECT OF THE DISC SPACE IN ORDER TO AID IN THE FUSION. THIS WAS DONE THROUGH THE OPPOSITE PORTAL THE CAGE WAS THEN PLACED ON THE CAGE INSERTION DEVICE INTO THE DISC SPACE. IT WAS FILLED IN THE USUAL FASHION USING ALLOGRAFT CHIP BONE.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264696 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