BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1203016 · Received October 21, 2008

    Report

    Report Number
    3004878714-2008-00041
    Event Type
    Injury
    Date Received
    October 21, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ARTIMPLANT AB
    Product Code
    KYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANT WAS SENT 10/06/2008 FOR HISTOLOGICAL ANALYSIS. RESULTS PENDING. EXPLANTATION WAS MADE OF THE CMC SPACER, DUE TO PERSISTENT PAIN. NO CONCLUSION AT THIS POINT.

    Description of Event or Problem · 1

    DR. REMOVED IMPLANT DUE TO PAIN. EXPLANT RECEIVED AT ARTIMPLANT IN 2008. SURGEON PERFORMED SUCCESSFUL ARTELON CASES.

    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 Other