BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1830994 · Received September 7, 2010

    Report

    Report Number
    1030489-2010-01146
    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
    Product Problem
    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 USED IN ANTERIOR CERVICAL SPINE FUSION. SPINE. 2006; 31: NUMBER 5, PP 542-547. H6: 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 UNDERGONE ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AUGMENTED WITH HIGH DOSE RHBMP-2. THE SURGICAL PROCEDURE WAS PERFORMED USING A MODIFIED SURGICAL TECHNIQUE. DECOMPRESSION AND DECORTICATION WERE CARRIED OUT AND THE CAGE WAS FILLED WITH RHBMP-2. ADD'L RHBMP-2 WAS ALSO PLACED LATERAL AND ANTERIOR TO THE GRAFT WITHIN THE DISC SPACE - UP TO 2.1 MG/LEVEL WAS USED. AN ANTERIOR CERVICAL PLATE WAS THEN PLACED. INTRAOPERATIVE RADIOGRAPH CONFIRMED PROPER ALIGNMENT AND FIXATION OF THE BONE GRAFT AND PLATE. IT WAS REPORTED THAT ONE PT WHO HAD UNDERGONE A 2-LEVEL NONCONTIGUOUS ACDF DEVELOPED A HEMATOMA. A DRAIN WAS PLACED - SURGICAL EVACUATION WAS NOT REQUIRED. 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 UNK Required Intervention