BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEFEE PLATE IMPLANT

    MDR report key: 11211 · Received February 2, 1994

    Report

    Report Number
    MW1000583
    Event Type
    Injury
    Date Received
    February 2, 1994
    Manufacturer
    UNKNOWN
    Product Code
    KWQ
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BONE PLATE WAS IMPLANTED AS A SPINAL IMPLANT (NOT FDA APPROVED FOR SPINAL IMPLANT). RPTR HAS NUMBNESS IN LOWER LEFT FOOT, SORENESS/INCREASED PAIN IN LOWER BACK AND LEGS; PLATE CAUSING SPINAL COLUMN TO STRAIGHTEN. FAILED SURGERY TO REMOVE PLATES 11/1/92. DR WAS UNABLE TO REMOVE BECAUSE OF BONE GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEFEE PLATE IMPLANT Implant KWQ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Not Applicable| O