BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1569419 · Received January 4, 2010

    Report

    Report Number
    3004878714-2009-00044
    Event Type
    Injury
    Date Received
    January 4, 2010
    Date of Event
    November 9, 2009
    Report Date
    December 22, 2009
    Manufacturer
    ARTIMPLANT AB
    Product Code
    KYI
    PMA / PMN Number
    K040070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION BASED ON FEEDBACK FROM DISTRIBUTOR ONLY. NO CERTAIN CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    CMC SPACER EXPLANTED DUE TO FOCAL SWELLING AND REDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTELON CMC SPACER SPACER KYI ARTIMPLANT AB 21109

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other