BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX, INC

    MDR report key: 949369 · Received November 13, 2007

    Report

    Report Number
    MW5004437
    Event Type
    Injury
    Date Received
    November 13, 2007
    Date of Event
    May 9, 2006
    Report Date
    November 13, 2007
    Manufacturer
    ARTHREX, INC
    Product Code
    HTN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2006, I WAS OPERATED ON FOR A BROKEN ANKLE. ONE OF THE MEDICAL DEVICES USED, IN ADDITION TO STEEL PLATES AND SCREWS WAS THE "MIMI TIGHTROPE." THE FIBER WIRE IN THE DEVICE CAUSED A SERIOUS INFECTIONS WHICH RESULTED IN ANOTHER OPERATION TO REMOVE THE DEVICE AND A LENGTHY PERIOD OF RECOVERY, REQUIRING INFUSION OF VANCOMYCIN OVER SIX WEEKS. THE VANCOMYCIN DESTROYED ALL THE GOOD BACTERIA IN MY SYSTEM AND MADE ME SUSCEPTIBLE TO PSORIASIS, WITH WHICH I STILL SUFFER WITH. MY PURPOSE OF REPORTING THIS INCIDENT IS DUE TO THE FACT THAT ACCORDING TO MY SURGEON, THERE WERE "TWO OR THREE" OTHER PATIENTS THAT ALSO HAD INFECTIONS. IT IS MY UNDERSTANDING THAT SUCH MEDICAL PROBLEMS ARE TO BE REPORTED. IN CHECKING THE VARIOUS SITES, I FIND NO MENTION OF PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX, INC MINI TIGHTROPE HTN ARTHREX, INC AR-8911DS *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| O| R| S