BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPIPHYSIS LIMB SALVAGE SYSTEM

    MDR report key: 1911820 · Received May 21, 2010

    Report

    Report Number
    1911820
    Event Type
    Malfunction
    Date Received
    May 21, 2010
    Date of Event
    May 6, 2010
    Report Date
    May 21, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BONE PROSTHESIS WAS SURGICALLY IMPLANTED FOR EWINGS SARCOMA(BONE CANCER LEG). THIS PARTICULAR DEVICE IS DESIGNED TO "GROW" WITH THE PATIENT. APPARENTLY, IT "GREW" TOO FAST AND THE CHILD WAS IN SEVERE PAIN. FURTHER SURGERY WAS PERFORMED TO DISABLE THE EXPANSION MECHANISM AND SECURE THE REST OF THE DEVICE AT THE RIGHT LENGTH, LEAVING IT IN INTACT. THE PT WILL REQUIRE FURTHER SURGERY AS HE GROWS.====================== HEALTH PROFESSIONAL'S IMPRESSION======================UNCLEAR. THE ORTHOPEDIST SPENT A LONG TIME CONSULTING WITH THE ENGINEERS AT WRIGHT MEDICAL, REVIEWING XRAYS WITH THEM ETC. THIS IS A VERY NEW DEVICE AND WAS CUSTOM MADE. IT IS ALSO THE FIRST TIME EVER A DEVICE OF THIS NATURE HAS BEEN PLACED IN A PATIENT THIS YOUNG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPIPHYSIS LIMB SALVAGE SYSTEM BONE PROTHSESES KRO WRIGHT MEDICAL TECHNOLOGY INC * 1039094

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR