BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2871915 · Received December 13, 2012

    Report

    Report Number
    1030489-2012-02795
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    March 14, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 UNDERWENT A L5-S1 FUSION USING RHBMP-2/ACS. THE PATIENT'S POST-OPERATIVE PERIOD WAS REPORTEDLY MARKED BY SEVERE PAINFUL AND DEBILITATING COMPLICATIONS. IT IS FURTHER ALLEGED THAT THE PATIENT EXPERIENCED ECTOPIC BONE GROWTH ONTO OR AROUND THE SPINAL CORD AND/OR NERVES WHICH CAUSED DEBILITATING PAIN IN THE LEGS AND BACK, ONGOING CHRONIC PAIN AND OTHER COMPLICATIONS DURING THE POST-OPERATIVE PERIOD. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: ON (B)(6) 2007, PATIENT UNDERWENT FOLLOWING PROCEDURE: 360 DEGREE FUSION THROUGH A POSTERIOR ONLY APPROACH ( TRANSFORAMINAL INTERBODY FUSION) L5-S1, ANTERIOR INTERBODY FUSION CAGE, LOCAL BONE, BONE BANK BONE AND RHBMP-2/ACS L5-S1, POSTERIOR INSTRUMENTATION LEGACY L5-S1 POSTEROLATERAL FUSION, LOCAL BONE, BONE BANK BONE AND RHBMP-2/ACS L5-S1; FOR PRE-OP DIAGNOSIS OF: SPON DYLOLISTHESIS L5-S1. PATIENT WITH BACK AND LEG PAIN UNRESPONSIVE TO CONSERVATIVE THERAPY. AS PER-OP NOTES: "...THE ANTERIOR ASPECT OF DISC SPACE WAS PACKED WITH A COMBINATION OF LOCAL BONE, BONE BANK BONE AND RHBMP-2/ACS AND CAGE WAS PACKED USING MORSCELLIZED BONE. THE CAGE WAS THEN IMPACTED INTO THE DISK SPACE WITH GOOD FIT AND FIXATION... LATERAL GUTTERS PACKED WITH BONE GRAFT AND ADDITIONALLY WITH RHBMP-2/ACS ON THE CONTRALATERAL SIDE TO THIS TRANSFORAMINAL INTERBODY FUSION... THE PATIENT TOLERATED THE PROCEDURE WELL...¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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