BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3163390 · Received June 11, 2013

    Report

    Report Number
    1030489-2013-02212
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    November 21, 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 L5-S1 FUSION WHERE RHBMP-2 WAS MIXED WITH AUTOGRAFT AND IMPLANTED WITH MULTIPLE INTERBODY CAGES VIA A POSTERIOR APPROACH. 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) 2007, THE PATIENT PRESENTED WITH LUMBAR HERNIATED DISK, POSTLUMBAR LAMINECTOMY SYNDROME, LUMBAR RADICULITIS AND LUMBAR SPINAL STENOSIS. THE PATIENT UNDERWENT: L5-S1 POSTERIOR LUMBAR INTERBODY ARTHRODESIS, PLACEMENT OF INTERBODY FUSION DEVICE AT L5-S1 USING A CARBON FIBER CAGE, PLACEMENT OF AUTOLOGOUS BONE GRAFT HARVESTED FROM THE LAMINECTOMY FOR THE INTERBODY FUSION, PLACEMENT OF BMP-SOAKED COLLAGEN SPONGES (RHBMP-2) WITHIN THE INTERBODY FUSION DEVICE AT L5-S1. AS PER OP NOTES, ¿ BILATERAL CARBON FIBER CAGES FILLED WITH RHBMP-2 WAS THEN PLACED AT L5-S1. MORSELIZED AUTOGRAFT OBTAINED FROM LAMINECTOMY ALONG WITH A SMALL PIECE OF RHBMP-2 WAS ALSO PLACED ANTERIOR TO THE DEVICES. THE DEVICES WERE COUNTERSUNK TO 3 MM AND THE LATERAL FLUOROSCOPIC IMAGE CONFIRMED SATISFACTORY POSITIONING OF THE INTERBODY DEVICES AT L5-S1¿ NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264680 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 00043 YR Required Intervention