BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUBTALAR MBA SYSTEM

    MDR report key: 513667 · Received February 24, 2004

    Report

    Report Number
    2028840-2004-00009
    Event Type
    Other
    Date Received
    February 24, 2004
    Date of Event
    February 14, 2004
    Report Date
    February 23, 2004
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN FEB 2004, KINETIKOS MEDICAL, INC. WAS INFORMED OF THE EXPLANT OF A SUBTALAR MBA FOOT IMPLANT FROM A PATIENT TO ADDRESS PAIN AND TO REPLACE WITH A LARGER, MORE APPROPRIATE SIZE IMPLANT. NO DEVICE DEFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALAR MBA SYSTEM ORTHOPEDIC FOOT IMPLANT HRS KINETIKOS MEDICAL, INC. 05-0106 7524-3787

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other