BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION MCP

    MDR report key: 507694 · Received January 20, 2004

    Report

    Report Number
    1651501-2004-00003
    Event Type
    Other
    Date Received
    January 20, 2004
    Date of Event
    December 2, 2003
    Report Date
    January 20, 2004
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    KWF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE THAT WAS IMPLANTED IN THE LEFT INDEX FINGER MCP JOINT WAS REMOVED AND REPLACED WITH A SILICONE INTERPOSITIONAL SPACER OF THE SAME SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP TOTAL FINGER JOINT IMPLANT KWF ASCENSION ORTHOPEDICS, INC. MCP-100 02-405

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other