BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNIVERSAL TOTAL WRIST

    MDR report key: 760682 · Received September 12, 2006

    Report

    Report Number
    2028840-2006-00018
    Event Type
    Other
    Date Received
    September 12, 2006
    Date of Event
    August 29, 2006
    Report Date
    September 11, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON AUG 24, 2006, KINETIKOS MED, INC. WAS INFORMED OF THE PLANNED EXPLANT AND REPLACEMENT OF A UNI2 CARPAL POLY AND PLATE, ON FIVE DAYS LATER, ON A FEMALE PT ONE YEAR FOLLOWING DETECTION BY X-RAY OF A BROKEN CARPAL STEM (PT WAS ASYMPTOMATIC). THE EXPLANTED COMPONENTS WERE NOT RETURNED TO KINETIKOS MEDICAL, INC. FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL TOTAL WRIST ORTHOPEDIC WRIST IMPLANT HRS KINETIKOS MEDICAL, INC. 26-5000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other