BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3202297 · Received June 28, 2013

    Report

    Report Number
    MW5030711
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    December 15, 2009
    Report Date
    June 28, 2013
    Manufacturer
    STRYKER
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER STATES THAT AFTER SURGERY, SHE PT BEGAN EXPERIENCING EXCRUCIATING PAIN. AS TIME WENT ON THIS PAIN ONLY BECAME WORST. NOW SHE CAN BARELY WALK. SHE ALSO SUFFERS FOR BLADDER PROBLEMS AND BACK PAIN TOO. THIS DEVICE HAS CAUSED HER SERIOUS NERVE DAMAGE AND SINCE HER SURGERY SHE HAS NEVER FELT BETTER. NOW SHE CANNOT WORK AND EVEN THOUGH SHE HAS APPLIED FOR DISABILITY, IT HAS NOT YET BEEN APPROVE. SHE IS NOW HAVING PROBLEMS WITH HER LIVER AND PANCREAS AND SHE SUSPECTS IT SHOULD BE DUE TO THE SIDE EFFECTS OF THIS DEVICE IN HER BODY. DUE TO THE FACT THAT SHE HAS NO INSURANCE, SHE CANNOT BE SEEN BY A SPECIALIST EVEN THOUGH SHE HAS BEEN REFERRED BY HER PCP. SHE PLEADS WITH THE FDA TO HELP HER AND OTHERS IN THE SAME SITUATION LIKE HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296000 INFUSE BONE GRAFT NONE NEK STRYKER

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR