BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2003910 · Received March 1, 2011

    Report

    Report Number
    1030489-2011-00214
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: KEPLER, CHRISTOPHER K. ET AL. DELAYED PLEURAL EFFUSION AFTER ANTERIOR THORACIC SPINAL FUSION USING BONE MORPHOGENETIC PROTEIN-2. SPINE (PHILA PA 1976). 2011 JAN 25. BMP-2 - DETAILS NOT PROVIDED INTERBODY CAGE - DETAILS NOT PROVIDED. (B)(4). MULTIPLE PRODUCTS 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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 IN A LITERATURE ARTICLE THAT THE PATIENT UNDERWENT MINIMALLY INVASIVE THORACOTOMY AND THORACIC INTERBODY FUSION USING CAGES FILLED WITH BMP-2 SOMETIME BETWEEN (B)(6) 2007 AND (B)(6) 2009. THE PATIENT EXPERIENCED CHEST FULLNESS WITH SIGNIFICANT PLEURAL EFFUSION WHICH DELAYED THE PATIENT'S DISCHARGE HOME. THE CHEST FULLNESS IMPROVED DURING HOSPITALIZATION. THE PLEURAL EFFUSION RESOLVED WITHIN 5 MONTHS AND WAS CONFIRMED BY CHEST RADIOGRAPH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R