BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3170959 · Received June 14, 2013

    Report

    Report Number
    1030489-2013-02295
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NON-MEDICAL PROFESSIONAL THAT THE PATIENT UNDERWENT A PROCEDURE FOR TLIF AT L5-S1 WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND PLACED DIRECTLY INTO THE SPINE. SUBSEQUENTLY, THE PATIENT WAS ALLEGEDLY DIAGNOSED WITH ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED WITH THE PRE-OP DIAGNOSIS: L5-S1 DEGENERATIVE DISC DISEASE AND UNDERWENT RIGHT SIDED TRANSFORAMINAL LUMBAR INTERBODY FUSION WITH LATERAL FUSION INSTRUMENTATION, INTERBODY FUSION WITH ARDIS BONE GRAFT, AUTOGRAFT AND SMALL SPONGE OF BMP. PER OP-NOTES: ¿..WE THEN DISTRACTED THE DISK SPACE UTILIZING THE INCISION JACK TO 12 MM. WE THEN WENT AHEAD AND APPLIED THE PEDICLE SCREWS IN THE PATIENT¿S LEFT IN SITU. WE THEN PACKED THE INTERSPACE WITH AUTO AND ALLOGRAFT, CANCELLOUS BONE AND THEN TAPPED A 9X26X12MM HIGH GRAFT PACKED WITH BONE GRAFT AND RHBMP-2/ ACS. WE THEN PLACED THE TISSEEL PLUG IN THE ANNULOTOMY FOLLOWED BY DROPPING THE PEDICLE SCREWS AND RODS ON THE PATIENT¿ S RODS AND PACKED A SMALL AMOUNT OF LATERAL BONE BILATERALLY. WE THEN COMPRESSED GENTLY BILATERALLY AND LOCKED THE SCREWS WITH THE RESIDUAL LOCKING NUT AND THEN REMOVED THE POST. THE WOUND WAS IRRIGATED AND THEN THE INCISION WAS CLOSED. THE PATIENT TOLERATED THE PROCEDURE WELL. ¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271070 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 00039 YR Required Intervention