BEUDAMED
    FDA Adverse Event Other Summary report: N

    KINETIC GREAT TOE IMPLANT

    MDR report key: 586622 · Received March 29, 2005

    Report

    Report Number
    2028840-2005-00003
    Event Type
    Other
    Date Received
    March 29, 2005
    Date of Event
    February 4, 2004
    Report Date
    March 29, 2005
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    KWD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2005, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A KINETIC GREAT TOE (KGT) IMPLANT FROM A PATIENT OWING TO PAIN AND DISCOMFORT. THE EXPLANTED COMPONENTS WERE REQUESTED REPRETEDLY OVER THE FOLLOWING 3 WEEK PERIOD AND WERE ULTIMATELY RETURNED TO KMI FOR EVALUATION. THE EXPLANTING SURGEON WAS CONTACTED BY PHONE FOR DETAILS. THE PATIENT'S M/P TOE JOINT WAS SUBSEQUENTLY FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETIC GREAT TOE IMPLANT ORTHOPEDIC IMPLANT, TOE KWD KINETIKOS MEDICAL, INC. 01-2006,02-2016 K07383,8241-6

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other