BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3192768 · Received June 27, 2013

    Report

    Report Number
    1030489-2013-02559
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    February 17, 2017
    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. 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

    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

    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 AN L3-L5 FUSION USING RHBMP-2/ACS. THE PATIENT WAS DIAGNOSED WITH INJURIES INCLUDING BUT NOT LIMITED TO, ECTOPIC BONE GROWTH, AN INFLAMMATORY REACTION TO RHBMP-2/ACS, CHRONIC PAIN, AND ADDITIONAL SURGERIES. THE PATIENT HAS REQUIRED EXTENSIVE MEDICAL TREATMENT. REPORTEDLY, THE PATIENT HAS NEVER RECOVERED FROM HER SURGERY INVOLVING RHBMP-2/ACS, AND SHE CONTINUES TO HAVE DAILY SEVERE DISABLING PAIN THAT PREVENTS HER FROM PERFORMING MANY BASIC ACTIVITIES OF DAILY LIVING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON: (B)(6) 2005: PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SEVERE STENOSIS AT L3-L4 AND L4-L5. PATIENT UNDERWENT L3-L5 POSTEROLATERAL SPINAL FUSION. L3-L5 POSTERIOR INSTRUMENTATION 5.5 TITANIUM. RIGHT ILIAC CREST GRAFT SUPPLEMENTED WITH RHBMP-2 AND LOCAL BONE GRAFT. EMG STIMULATION. AS PER OP-NOTES, "ONCE THE SIMPULSING WAS DONE BONE GRAFT BOTH FROM THE GRAFT SITE AND ALSO FROM THE LOCAL BONE WAS PLACED IN THE LATERAL GUTTERS ON EITHER SIDE OF THE BMP ROLL THAT WAS PLACED FROM L3 TO L5. NEXT A SMALL PIECE OF BMP SPONGE WAS PLACED IN THE FACET JOINTS AT L3-4 AND L4-L5 FOLLOWED BY IMPACTION OF CANCELLOUS BONE. PATIENT WAS IN GOOD CONDITION WITH NO COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293803 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M114005AAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention