BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION PIP

    MDR report key: 515177 · Received March 4, 2004

    Report

    Report Number
    1651501-2004-00007
    Event Type
    Other
    Date Received
    March 4, 2004
    Date of Event
    February 5, 2004
    Report Date
    March 3, 2004
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE THAT WAS IMPLANTED IN THE LEFT LONG FINGER PIP JOINT PROXIMAL PHALANX WAS REMOVED AND REPLACED WITH ANOTHER DEVICE 2 SIZES SMALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION PIP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. PIP-200 03-456

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other