BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION PIP

    MDR report key: 511068 · Received February 5, 2004

    Report

    Report Number
    1651501-2004-00004
    Event Type
    Other
    Date Received
    February 5, 2004
    Date of Event
    January 8, 2004
    Report Date
    February 5, 2004
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE THAT WAS IMPLANTED IN THE RIGHT INDEX FINGER PIP JOINT WAS REMOVED AND REPLACED WITH ANOTHER DEVICE OF THE NEXT LARGER SIZE DISTAL COMPONENT AND THE SAME SIZE PROXIMAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. PIP-200 02-241

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other