BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL IMPLANT

    MDR report key: 20269 · Received March 14, 1995

    Report

    Report Number
    MW1005438
    Event Type
    Injury
    Date Received
    March 14, 1995
    Date of Event
    January 7, 1992
    Report Date
    February 27, 1995
    Manufacturer
    UNKNOWN
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 7/91 RPTR FELL. IN 9/91 DIAGNOSED WITH SPONDYLOLYSIS AND SPONDYLOSIS OF L-4, L-5, L5-S1, AND WAS SENT FOR BRACE FITTING. AFTER A FEW WEEKS, SURGERY DATE SET FOR 1/92. RPTR ASKED WHAT DR WAS GOING TO DO. THE SURGEON SAID "WE WILL STABILIZE THE AREA WITH FUSION." HE GAVE RPTR COPIES AND PICTURES OF DEVICES. RPTR ASKED IF THEY WERE NECESSARY. HE SAID "I'LL USE YOUR BONE FROM HIP AND THE REST WE'LL DECIDE IN SURGERY." AFTER SURGERY, WHEN RPTR STILL HAD PAIN, SHE SAW HER SURGEON UNTIL HER INSURANCE RAN OUT. THEN WHILE ON MEDICAID HE SAID "THIS WAS ALL I CAN DO FOR YOU; GO SEE DR THIS, DR THAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL IMPLANT SPINAL IMPLANT JDN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability