BEUDAMED
    FDA Adverse Event Summary report: N

    SPINAL IMPLANT

    MDR report key: 20271 · Received March 14, 1995

    Report

    Report Number
    MW1005440
    Date Received
    March 14, 1995
    Date of Event
    June 1, 1992
    Report Date
    February 25, 1995
    Manufacturer
    UNKNOWN
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSTANT LOWER BACK PAIN, LOSS OF FEELING IN RIGHT LEG, LOWER BACK WEAKNESS (PAIN BECOMES ACUTE IF STANDING LONGER THAN 30 MINUTES). CAN FEEL AND HEAR POPPING IN AREA OF IMPLANT. CANNOT "SLEEP IN", PAIN AWAKENS RPTR IF LYING DOWN TOO LONG.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR