BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTELON CMC SPACER

    MDR report key: 2440445 · Received January 31, 2012

    Report

    Report Number
    MW5024111
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    February 25, 2008
    Report Date
    January 31, 2012
    Manufacturer
    ARTIMPLANT SOLD BY SMALL BONE INNOVATIONS
    Product Code
    KYI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE ARTELON CMC SPACER, DEVELOPED BY ARTIMPLANT (B)(4) AND MARKETED BY SMALL BONE INNOVATIONS, INC IMPLANTED IN (B)(6) 2008. CONSEQUENT DISTAL THUMB PIP ARTHRITIS IN THE IMPLANTED THUMB WITH SEVERE EPL TENDINITIS LASTING TWO YEARS. EPL TENDON STILL BECOME SORE AND INFLAMED WITH USE. THUMB NO LONGER HAS FULL EXTENSION. SECOND OPINION IN 2008 BY ANOTHER HAND SURGEON SURMISED AN IMMUNOLOGICAL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTELON CMC SPACER ARTELON SPACER KYI ARTIMPLANT SOLD BY SMALL BONE INNOVATIONS UNIC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention