BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 1120903 · Received August 19, 2008

    Report

    Report Number
    3004878714-2008-00032
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    July 8, 2008
    Report Date
    August 15, 2008
    Manufacturer
    ARTIMPLANT AB
    Product Code
    KYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRAINED SURGEON FAMILIAR WITH JOINT SURGERY. EXPLANT REC'D IN 2008, BUT NOT IN FORMALIN. NO HISTOLOGICAL ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    DR EXPLANTED AN ARTELON IMPLANT.

    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 58 YR Other