BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 657774 · Received December 23, 2005

    Report

    Report Number
    2028840-2005-00011
    Event Type
    Other
    Date Received
    December 23, 2005
    Date of Event
    December 6, 2005
    Report Date
    December 21, 2005
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HWC
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN DEC 2005, KINETIKOS MEDICAL, INC., WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA ORTHOPEDIC IMPLANT TO ADDRESS PAIN REPORTED BY THE PT FIVE (5) MONTHS FOLLOWING THE ORIGINAL IMPLANT DATE. THE DEVICE WAS NOT RETURNED TO KMI FOR EVALUATION. AN INVESTIGATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HWC KINETIKOS MEDICAL, INC. 05-01XX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other