BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT OR RHBMP2

    MDR report key: 2820913 · Received October 31, 2012

    Report

    Report Number
    MW5027438
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    March 12, 2008
    Report Date
    October 3, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BACK SURGERY WHERE THE SURGEON USED A PRODUCT CALLED MEDTRONIC INFUSE. AFTER SOME TIME, I DEVELOPED OVERGROWN BONE, EXPERIENCED SIGNIFICANT PAIN AND SUFFERED OTHER SERIOUS INJURIES. DATES OF USE: (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INFUSE BONE GRAFT OR RHBMP2 MEDTRONIC INFUSE NEK MEDTRONIC, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention| S