BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSION MCP

    MDR report key: 1321299 · Received February 6, 2009

    Report

    Report Number
    1651501-2009-00007
    Event Type
    Other
    Date Received
    February 6, 2009
    Date of Event
    February 29, 2008
    Report Date
    February 5, 2009
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    MPK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMPLANT WAS PLACED IN 2008. AT APPROX 1 MONTH POST-OP, PATIENT SUSTAINED "SIGNIFICANT TRAUMA TO THE RIGHT HAND". SUBSEQUENT RADIOGRAPHS NOTED A FRACTURE IN THE DISTAL COMPONENT. IMPLANT WAS REVISED A MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSION MCP TOTAL FINGER JOINT IMPLANT MPK ASCENSION ORTHOPEDICS, INC. MCP-100 (DISTAL) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other