BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC INFUSE BONE GRAFT

    MDR report key: 2920025 · Received January 15, 2013

    Report

    Report Number
    MW5028621
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2007
    Report Date
    January 15, 2012
    Manufacturer
    MEDTRONIC INC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFUSE WAS IMPLANTED DURING SPINAL SURGERY AND PT COMPLAINING ABOUT HAVING SERIOUS INJURY INCLUDING PAIN AND ANGUISH. THE DISC HAS MOVED FROM L1-L5 TO SCIATIC NERVE CAUSING NERVE DAMAGE AND PAIN THAT FEELS LIKE PINS AND NEEDLES GOING FROM HIS RIGHT LEG TO HIS FOOT. NERVE DAMAGE ALSO AFFECTING HIS SEXUAL ACTIVITIES AND HE CAN NO LONGER FUNCTION ON THE SAME LEVEL. PLEASE SEEN ANY INFO RELATING TO RECALL OF DEVICE TO PT BY MAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23286 MEDTRONIC INFUSE BONE GRAFT RHBMP INFUSE BONE GRAFT NEK MEDTRONIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention