BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JOHNSON AND JOHNSON (DEPUY SPINE, INC)

    MDR report key: 889493 · Received August 2, 2007

    Report

    Report Number
    MW5003284
    Event Type
    Injury
    Date Received
    August 2, 2007
    Date of Event
    June 16, 2005
    Report Date
    June 1, 2007
    Product Code
    MJO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST DEVICE SURGERY, THE WRONG SIZE CHARITE DISC IMPLANT WAS USED AND POSITIONED INCORRECTLY, (2005). THE SECOND REPLACEMENT SURGERY IN 2006 WAS POSITIONED BETTER; HOWEVER, I NEVER FULLY RECOVERED AND CONTINUE TO TAKE SEVERAL PAIN MEDICATIONS. ESSENTIALLY, THE PRODUCT HAS RESULTED IN FAR MORE PAIN THAN I NEVER HAD BEFOREHAND. PRIOR AND AFTER SURGERIES, I HAVE HAD MULTIPLE SPINAL BLOCK INJECTIONS, NONE OF WHICH WORKED. DATE OF USE: SINCE 2005. DIAGNOSIS OR REASON FOR USE: LOW BACK PAIN; DEGENERATED DISC. EVENT REAPPEARED AFTER REINTRODUCTION? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHNSON AND JOHNSON (DEPUY SPINE, INC) CHARITE DISC MJO

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability THERAPY