BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 3131015 · Received May 8, 2013

    Report

    Report Number
    3004878714-2013-00012
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    May 7, 2013
    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 US, INC. NO INFORMATION SUPPORTING THE ALLEGATIONS OF LAWSUIT CURRENTLY AVAILABLE.

    Description of Event or Problem · 1

    AN ARTELON CMC SPACER HAS BEEN EXPLANTED DUE TO ALLEGED INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202510 ARTELON CMC SPACER SPACER KYI ARTIMPLANT AB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention