BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE SPINE MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2903816 · Received January 4, 2013

    Report

    Report Number
    MW5028459
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    March 20, 2006
    Report Date
    December 29, 2012
    Manufacturer
    LIFE SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CERVICAL FUSION SURGERY, ENTIRE LEFT SIDE WHERE THE IMPLANT IS INSTALLED, HURTS ME SO. IT IS SORE, IT BURNS, IT'S NUMB, AND STIFF WITH PAIN ALL DAY (24-7). I MEAN MY ENTIRE LEFT SIDE FROM MY HEAD TO MY LEFT FOOT HURTS. I CAN NOT LIFT, PUSH OR PULL ANYTHING. I HAVE SUFFERED WITH THIS FOR SIX LONG YEARS. I HAVE DIFFICULTY SWALLOWING, BREATHING AND SPEAKING. I HAVE LOTS OF SWELLING AND INFLAMMATION, I HAVE BECOME DISABLED FROM THE IMPLANT SURGERY AND I NEED THE IMPLANT REMOVED. I WANT TO WORK AGAIN, I AM YOUNG. DR. (B)(6) HAS BEEN TOLD OF MY CONDITION SINCE 2006. HE HAS NOT DONE THE APPROPRIATE MEDICAL CARE FOR ME. I NEED HELP. MEDICAL ATTENTION. DATES OF USE: IMPLANT INSTALLED IN (B)(6) 2006. DIAGNOSIS OR REASON FOR USE: RIGHT NECK AND SHOULDER PAIN. DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4241 LIFE SPINE MODIFICATION TO LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE KWQ LIFE SPINE 510(K) K062831
    4347 OSMOSYS BONE FUSION MQV MEDICREA USA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R| S MUSCULOSKELETAL TRANSPLANT FOUNDATION| SERIAL # (B)(4)