BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1339304 · Received March 11, 2009

    Report

    Report Number
    3004878714-2009-00006
    Event Type
    Injury
    Date Received
    March 11, 2009
    Date of Event
    August 5, 2008
    Report Date
    March 2, 2009
    Manufacturer
    ARTIMPLANT
    Product Code
    KYI
    PMA / PMN Number
    K40070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CMC SPACER EXPLANTED AFTER 10 MONS DUE TO JOINT STIFFNESS. ORIGINAL DIAGNOSIS EATON STAGE II ARTHRITIS. PT WAS PAIN FREE AT 9 WEEKS POSTOP BUT STIFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTELON CMC SPACER SPACER KYI ARTIMPLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other FIXATION WITH SUTURE ANCHORS