BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5317524 · Received December 22, 2015

    Report

    Report Number
    1030489-2015-03551
    Event Type
    Injury
    Date Received
    December 22, 2015
    Report Date
    November 23, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT UNDERWENT 1) L3 LAMINECTOMY, MEDIAL FACETECTOMY, BILATERAL FORAMINOTOMY. 2) L4 LAMINECTOMY, MEDIAL FACETECTOMY, BILATERAL FORAMINOTOMY. 3) L3-4 POSTERIOR LUMBAR INTERBODY FUSION. 4) L3-4 POSTEROLATERAL ARTHRODESIS. 5) L3-S1 INTERNAL FIXATION WITH INNOVASIS SPINAL ROD SYSTEM. 6) REMOVAL OF PREVIOUSLY PLACED SEGMENTAL SPINAL ROD SYSTEM WITH INSPECTION OF POSTEROLATERAL FUSION MASS. 7) RESECTION OF EXTRADURAL MASS ON THE LEFT SIDE AT L3-4. 8) HARVEST OF LOCAL BONE GRAFT. 9) UTILIZATION OF BONE MORPHOGENIC PROTEIN IN POSTEROLATERAL FUSION MASS. 10) UTILIZATION OF THE X-BOX EXPANDABLE INTERBODY FUSION BIOMECHANICAL DECVICE AT L3-4. PREOPERATIVE DIAGNOSIS: L3-4 STENOSIS, EXTRADURAL MASS STATUS POST L4-S1 FUSION IN THE PAST. PEROP NOTES: A LAMINECTOMY WAS PERFORMED AT L3-4 DECOMPRESSING THE NERVE ROOTS AND THECAL SAC WIDELY BILATERALLY. THE VERTEBRAL BODIES WERE COMPRESSED WITH THE INTERBODY FUSION DEVICE BEFORE COPIOUSLY WITH HYDROGEN PEROXIDE AND ANTIBIOTIC SOLUTION. LATERAL MASS ALONG WITH THE BMP WERE PALCED IN THESE AREA. DURAGEN WAS PLACED OVER THE DURA. ON AN UNKNOWN DATE POST-OP PATIENT ALLEGED UNSPECIFIED INJURIES DUE TO USE OF RHBMP-2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844819 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111105AAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other