BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KALIX

    MDR report key: 376171 · Received May 14, 2002

    Report

    Report Number
    9615741-2002-00001
    Event Type
    Injury
    Date Received
    May 14, 2002
    Date of Event
    November 6, 2001
    Report Date
    February 6, 2002
    Manufacturer
    NEWDEAL SA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A KALIX FLAT FOOT IMPLANT HAS BEEN IMPLANTED IN 2001, ON X-RAYS DATED 21 DAYS LATER, IT CAN BE SEEN THAT THE TWO METALLIC COMPONENTS OF THE IMPLANT WERE DISMANTLED. A REVISION SURGERY WAS PERFORMED ON 13 DAYS LATER, IN ORDER TO REMOVE THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KALIX FLAT FOOT IMPLANT HWC NEWDEAL SA KALIX FLAT FOOT IMPLANT B041

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention