BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIPER DISTAL VOLAR RADIUS PLATE IMPLANT

    MDR report key: 669515 · Received January 27, 2006

    Report

    Report Number
    2028840-2006-00002
    Event Type
    Other
    Date Received
    January 27, 2006
    Date of Event
    January 1, 2006
    Report Date
    January 26, 2006
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2006, KINETIKOS MED, INC., WAS INFORMED OF THE PLANNED EXPLANT OF A VIPER DISTAL VOLAR RADIUS PLATE IMPLANT SYSTEM FROM A FEMALE PT OWING TO PAIN. THE SURGERY WAS PERFORMED ON AN UNIDENTIFIED DATE LATER IN THE MONTH. THE EXPLANTED COMPONENTS WERE RETURNED TO KMI FOR EVALUATION IN 2006. NO PRODUCT DEFECTS OR NON-CONFORMITIES WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIPER DISTAL VOLAR RADIUS PLATE IMPLANT ORTHOPEDIC WRIST/ARM IMPLANT HRS KINETIKOS MEDICAL, INC. 28-0064 8790

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other