BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KALIX

    MDR report key: 444004 · Received February 19, 2003

    Report

    Report Number
    9615741-2003-00002
    Event Type
    Injury
    Date Received
    February 19, 2003
    Date of Event
    January 31, 2003
    Report Date
    February 19, 2003
    Manufacturer
    NEWDEAL SA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A KALIX FLAT FOOT IMPLANT HAS BEEN IMPLANTED IN 2002. ON 3 MONTHS POSTOP X-RAYS (DATED 2003), IT CAN BE SEEN THAT THE TWO METALLIC COMPONENTS OF THE IMPLANT ARE COMPLETELY DISMANTLED. A REVISION SURGERY WAS PERFORMED (30 DAYS LATER), IN ORDER TO REMOVE THE IMPLANT. THE SURGEON REPLACED THE DISMANTLED KALIX BY ANOTHER KALIX ONE SIZE BIGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KALIX FLAT FOOT IMPLANT HWC NEWDEAL SA KALIX FLAT FOOT IMPLANT B063

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention