BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4157185 · Received October 9, 2014

    Report

    Report Number
    1030489-2014-03991
    Event Type
    Injury
    Date Received
    October 9, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 10, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: KELLY ET AL. CANCER RISK FROM BONE MORPHOGENETIC PROTEIN EXPOSURE IN SPINAL ARTHRODESIS. J BONE JOINT SURG AM. 201 4;96:1417-22. IMPLANT DATE: 2005 - 2009. (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 MEDICARE PATIENT DATA FROM JANUARY 1, 2005, TO DECEMBER 31, 2010, WERE REVIEWED. PATIENTS HAVING SPINAL ARTHRODESIS FROM 2005 TO 2009 WERE FOLLOWED FROM THE DATE OF SURGERY UNTIL THAT DATE IN 2010. 467,916 MEDICARE PATIENTS WHO HAD SPINAL ARTHRODESIS WERE IDENTIFIED. BMP WAS USED IN 110,808 PATIENTS (23.7%). IN THE BMP GROUP, 6557 PATIENTS (5.9%) DEVELOPED A SEER CANCER COMPARED WITH 23,232 PATIENTS (6.5%) IN THE CONTROL GROUP AFTER SPINAL ARTHRODESIS. THE DIFFERENCE WAS SIGNIFICANT (P <(><<)> 0.001), INDICATING A LOWER RISK IN THE BMP GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635913 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R