BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 2500083 · Received March 13, 2012

    Report

    Report Number
    3004878714-2012-00002
    Event Type
    Injury
    Date Received
    March 13, 2012
    Report Date
    March 13, 2012
    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

    INVESTIGATION BASED ON LAWSUIT DOCUMENTS FILED AGAINST ARTIMPLANT (B)(4) AND ARTIMPLANT (B)(4). NO INFO SUPPORTING ALLEGATIONS OF LAWSUIT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    AN ARTELON CMC SPACER IS PLANNED FOR EXPLANTATION (DATE UNK) DUE TO ALLEGED INJURY. COMPLAINT NO (B)(4).

    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