BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1830995 · Received September 7, 2010

    Report

    Report Number
    1030489-2010-01141
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    March 14, 2005
    Report Date
    August 16, 2010
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: SHIELDS ET AL. ADVERSE EFFECTS ASSOCIATED WITH HIGH-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 USE IN ANTERIOR CERVICAL SPINE FUSION. SPINE. 2006; 31: NUMBER 5, PP 542-547. DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WITHOUT ADD'L DEVICE INFO, A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE. WE ARE, THEREFORE, UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPLICATIONS WERE OBSERVED IN PTS WHO HAD ANTERIOR CERVICAL FUSION PROCEDURES AUGMENTED WITH HIGH-DOSE RHBMP-2 AND AN ABSORBABLE COLLAGEN SPONGE. THE SURGICAL PROCEDURE WAS PERFORMED USING A MODIFIED SURGICAL TECHNIQUE. AT THE COMPLETION OF THE DECOMPRESSION IN THE ANTERIOR CERVICAL VERTEBRECTOMY AND FUSION, THE FORAMINA WERE OPENED BILATERALLY, A CAGE WAS APPROPRIATELY SIZED, CUT, CONTOURED, AND PACKED WITH A COMBINATION OF LOCAL BONE AND RHBMP-2. ADD'L RHBMP-2, GREATER THAN 2.1MG/LEVEL, WAS PACKED ANTERIOR AND LATERAL TO THE CAGE. A CERVICAL PLATE WAS THEN PLACED. RADIOGRAPHS CONFIRMED APPROPRIATE POSITIONING OF THE PLATE AND CAGE. LESS THAN FOUR DAYS POSTOPERATIVELY, PT WHO HAD UNDERGONE A 2-LEVEL VERTEBRECTOMY DEVELOPED A HEMATOMA THAT REQUIRED SURGICAL EVACUATION. NO DETAILS OR OUTCOMES WERE MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention