BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL IMPLANT

    MDR report key: 21333 · Received April 20, 1995

    Report

    Report Number
    MW1005686
    Event Type
    Injury
    Date Received
    April 20, 1995
    Date of Event
    August 13, 1993
    Report Date
    March 25, 1995
    Manufacturer
    SMITH AND NEPHEW RICHARDS
    Product Code
    JDN
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONTINUOUS PAIN AT AND AROUND INCISION SITE. PERIODIC SEVERE SHARP PAINS THAT RADIATE TO LEFT HIP AND BUTTOCKS WITH RADIATING PAIN TO RIGHT LEG, PROTRUSION OF HARDWARE PREVENTING HIM FROM LYING SUPINE WITHOUT PAIN, SEVERE PAIN WITH CHANGES IN TEMPERATURE DUE TO RODS AND SCREWS GETTING HOT OR COLD, DECREASED FLEXIBILITY, DIFFICULT TO STAND OR SIT FOR LONG PERIODS OF TIME WITHOUT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL IMPLANT SPINAL IMPLANT JDN SMITH AND NEPHEW RICHARDS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Disability