BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL IMPLANT

    MDR report key: 20101 · Received March 2, 1995

    Report

    Report Number
    MW1005308
    Event Type
    Injury
    Date Received
    March 2, 1995
    Date of Event
    December 21, 1991
    Report Date
    February 10, 1995
    Manufacturer
    UNKNOWN
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 3/3/94 HAD SPINAL FUSION WITH HARDWARE TO SPINE. WHILE IN HOSP, GOT STAPH INFECTION. STAYED IN HOSP UNTIL FIRST WEEK OF APRIL. TAKEN BACK TO SURGERY 3 TIMES. AFTER GOING HOME FOR ABOUT 5 DAYS, READMITTED TO HOSP WITH SEVERE PAIN IN ALL JOINTS AND INABILITY TO MOVE IN BED OR EVEN TURN OVER WITHOUT SOMEONE TURNING HER. ALSO SEVERE SPASMS IN LEGS. SHE WAS ON 16 WEEKS OF IV ADMINISTERING TO HERSELF 3 TIMES A DAY WITH NURSES COMING 3 TIMES A WEEK AND LAB WORK DRAWN ONCE A WEEK. IN 10/94 WENT BACK TO DOCTOR. HE STATED HARDWARE WAS LOOSE AND NEEDED TO COME OUT. ALSO STATED FUSION WAS NOT TAKING AND SHE HAD A CRACK ON THE LEFT SIDE OF THE SPINE AREA. INFECTIOUS DISEASE DOCTOR TOLD DOCTOR THE HARDWARE NEEDED TO COME OUT. HE TOLD PT THAT EVEN WITH ALL THE PROBLEMS, SHE HAD A 95% CHANCE OF NEVER HAVING ANY MORE PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Congenital Anomaly| H| R| S