BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INFUSE BONE GRAFT

    MDR report key: 5888350 · Received August 17, 2016

    Report

    Report Number
    MW5064182
    Event Type
    Injury
    Date Received
    August 17, 2016
    Date of Event
    October 30, 2008
    Report Date
    July 26, 2016
    Manufacturer
    MEDTRONIC PLC
    Product Code
    NEK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY HANDS HAVE NOT OPERATED (NUMBNESS PROPERLY SINCE SURGERY. THE LEFT SIDE HURT AND WELL AS THE RIGHT SIDE. TROUBLE SWALLOWING. BREATHING WHILE ASLEEP. IT WAS DISCOVERED THAT I HAD SEVERAL BULGING DISC IN MY NECK. THE 1ST SURGERY DID NOT HEAL PROPERLY. I WAS REDONE THE 2ND TIME FROM THE BACK OF MY HEAD DOWN MY NECK. IMMEDIATELY AFTER THE 2ND SURGERY. MY LIFE WAS FOREVER CHANGED. I NEVER HAD AN ACCIDENT NOR FELL. SINCE THESE SURGERIES MY LEFT HAS CHANGED 180 DEGREES. THROUGH DEBILITATING PAIN I DO SOME THING EVERYDAY TO MAKE MY LIFE BETTER. I DO SOMETHING EVERYDAY TO MAKE MY LIFE BETTER. I BEGAN THESE SURGERIES AT (B)(6) LBS AND HAVE LOST OVER 100 POUNDS THROUGH LIFE CHANGES AND HOPING FOR IMPROVEMENT. BUT NO MATTER HOW MUCH WEIGHT I LOSE THE CHRONIC PAIN STILL EXIST AND EVEN GETS WORSE AFTER I EXERCISE BUT IF I DIDN'T. I WAS TOLD THAT I WOULD POSSIBLY BE IMMOBILE AND THAT'S NOT GOING TO HAPPEN! BOTH SURGERIES WERE DONE. AT (B)(6). APPROX 1 WEEK AFTER THE SECOND SURGERY, THE ENTIRE PRACTICE WAS DISMANTLED AND I HAVEN'T SEEN DR. (B)(6) SINCE BUT I DID FIND HIM ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534611 MEDTRONIC INFUSE BONE GRAFT BONE GRAFT NEK MEDTRONIC PLC M110801AAC
    534612 MEDTRONIC INFUSE BONE GRAFT BONE GRAFT NEK MEDTRONIC PLC M110801AAC
    534613 VITOSS BA BIOACTIVE BONE GRAFT SUBSTITUTE MQV MEDTRONIC PLC 0310013
    534614 VITAGEL SURGICAL HEMOSTAT LMF MEDTRONIC PLC A310019

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R| S