BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1841317 · Received September 13, 2010

    Report

    Report Number
    1030489-2010-01181
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    February 17, 2006
    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
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: SMUCKER, ET AL. INCREASED SWELLING COMPLICATIONS ASSOCIATED WITH OFF-LABEL USAGE OF RHBMP-2 IN THE ANTERIOR CERVICAL SPINE. SPINE. 2006; VOLUME 31, NUMBER 24: PP 2813-2819. A REVIEW OF THE DEVICE HISTORY RECORDS CANNOT BE PERFORMED WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS, IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    SWELLING COMPLICATIONS WERE REPORTED IN A RETROSPECTIVE STUDY OF PTS WHO UNDERWENT ANTERIOR CERVICAL FUSION USING RHBMP-2. FUSION WAS PERFORMED THROUGH A STANDARD SURGICAL APPROACH USING RHBMP-2 AT A CONCENTRATION OF 1.5MG/ML, HOWEVER THE ACTUAL DOSE OF RHBMP-2 APPLIED COULD NOT BE DETERMINED. IN THIS PT, IT IS NOT KNOWN IF RHBMP-2 WAS PLACED IN A CORTICAL RING ALLOGRAFT OR INTERBODY SPACER, AND/OR AROUND THE GRAFT ITSELF IN THE DISC SPACE. THE SWELLING COMPLICATION OCCURRED IN A DELAYED FASHION AFTER A SEEMINGLY UNEVENTFUL SURGERY, EXTUBATION, AND INITIAL POSTOPERATIVE COURSE. SEVEN DAYS POST OPERATIVELY, THIS PT WHO UNDERWENT AN INITIAL 3-LEVEL ANTERIOR CERVICAL FUSION WAS TAKEN BACK TO SURGERY FOR EXPLORATION AND DRAINAGE OF A SWOLLEN ANTERIOR NECK. ALTHOUGH THE PT HAD SUBJECTIVE COMPLAINTS OF DYSPNEA AND THERE WAS THE CONCERN ABOUT THE POSSIBILITY OF AIRWAY COMPROMISE IF SURGICAL MANAGEMENT WERE NOT PERFORMED, AN ACUTELY COMPROMISED AIRWAY WAS NOT DEMONSTRATED. INTRAOPERATIVELY, NO ACUTE HEMATOMA OR LARGE FLUID COLLECTION WAS NOTED. INSTEAD, THE SWELLING WAS DIFFUSE WITHIN THE SOFT TISSUE WITHOUT ANY DRAINABLE FLUID COLLECTION. THE PT RECOVERED UNEVENTFULLY.

    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