BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO STIMULATOR

    MDR report key: 3027481 · Received March 22, 2013

    Report

    Report Number
    MW5029515
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    August 1, 2008
    Report Date
    March 22, 2013
    Manufacturer
    DJO LLC
    Product Code
    LOF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, I WAS GIVEN A DJO BONE GROWTH STIMULATOR AT THE HOSP BEFORE I CHECKED OUT. MY FIRST CERVICAL FUSION WAS 1 YEAR PREVIOUS THAT DID NOT "TAKE". IN 2009, I HAD A 3RD CERVICAL TYPE FUSION THAT WAS DONE IN THE BACK OF MY NECK, WHICH I WAS TOLD IT WAS KIND OF A BARBWIRE PROCEDURE. IN 2010, I HAD AN X-RAY WHICH SHOWED A SMALL BONE SPUR GROWING FROM THE VERTEBRAE ABOVE MY PLATE, WHICH WAS A SHOCK TO ME. WITH THE CHRONIC PAIN, I STILL HAVE EXPERIENCED TO THIS DAY. A YEAR LATER, THE X-RAY SHOWED THE BONE SPUR WHICH GREW ALMOST TOUCHING MY PLATE. IN 2012, MY X-RAY SHOWED THAT IT STARTED TO CHANGE SHAPE. YESTERDAY (B)(6) 2013, I FOUND OUT THAT MY SHOULDER WAS GROWING A BONE SPUR UNDER THE ACCRONIUM. IN 2008, I HAD A LEFT ROTATOR CUFF SURGERY, WHICH MY A/C JOINT WAS CUT, I AM NOW LOOKING AT ANOTHER SURGERY WHICH WILL INCLUDE MY LEFT SHOULDER AND MY NECK TO REMOVE THE BONE SPUR. I WORE THE DJO STIMULATER 8-10 HRS A DAY, THE LONGER TIME WAS BETTER WHICH I WAS TOLD. DUE TO THAT I HAVE BONE SPURS IN MY SHOULDER AND MY NECK. I HAVE CHRONIC PAIN SINCE I HAD MY 1ST SURGERY. I AM (B)(6), A MOM OF 5 KIDS, I HAVE A SPECIAL NEEDS DAUGHTER ALSO. THIS STIMULATOR HAS RUINED MY LIFE. NOT FOR NOW, BUT FOR LIFE. DATE OF USE: (B)(6) 2007 - (B)(6) 2009.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR ON (B)(6) 2013: WHEN SPEAKING WITH THE INITIAL REPORTER (AS LISTED ON THE REPORT), OUR QUALITY EMPLOYEE INITIATING THE REVIEW WAS ABLE TO DETERMINE THIS EVENT DID NOT INVOLVE A DJO, LLC DEVICE. PER THE INITIAL REPORTER THE DEVICE WAS AN "ORTHOFIX CERVICAL STIMULATOR". SHE WAS ABLE TO PROVIDE US WITH A SERIAL NUMBER: (B)(4). (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120408 DJO STIMULATOR BONE GROWTH STIMULATOR LOF DJO LLC TRIAL PATIENT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| S