BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1933852 · Received December 17, 2010

    Report

    Report Number
    3004878714-2010-00011
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 10, 2010
    Manufacturer
    ARTIMPLANT AB
    Product Code
    KYI
    PMA / PMN Number
    K040070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DATE: (B)(4) 2007. INVESTIGATION BASED ON LAWSUIT DOCUMENTS FILED AGAINST ARTIMPLANT USA, INC. NO INFORMATION SUPPORTING ALLEGATIONS OF LAWSUIT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    AN ARTELON CMC SPACER WAS EXPLANTED DUE TO ALLEGED FOREIGN BODY TYPE REACTION WITH SOFTENING OF THE THUMB METACARPAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other