BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUBTALER M.B.A.

    MDR report key: 431626 · Received December 5, 2002

    Report

    Report Number
    2028840-2002-00046
    Event Type
    Injury
    Date Received
    December 5, 2002
    Report Date
    December 2, 2002
    Manufacturer
    KINETIKOS MEDICAL, INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON DECEMBER 02, 2002, KMI WAS NOTIFIED OF THE EXPLANT OF A SUBTALAR M.B.A. TO ADDRESS PAIN REPORTED BY THE PT AFTER AN INDETERMINATE PERIOD FOLLOWING THE ORIGINAL IMPLANT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUBTALER M.B.A. ORTHOPEDIC IMPLANT (FOOT) HRS KINETIKOS MEDICAL, INC. 05-0XXX NI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R