BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KMI

    MDR report key: 340126 · Received June 29, 2001

    Report

    Report Number
    MW1022294
    Event Type
    Malfunction
    Date Received
    June 29, 2001
    Date of Event
    June 5, 2001
    Report Date
    June 25, 2001
    Manufacturer
    KMI
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUBTALAR ARTHRODESIS WITH MBA IMPLANT PERFORMED. UTILIZING THE SIZER SET, SURGEON DETERMINED THAT A SIZE #9 IMPLANT WAS APPROPRIATE. WHEN THE SIZE #9 IMPLANT WAS INSERTED THE SCREWDRIVER WOULD NOT DISENGAGE FROM THE IMPLANT ITSELF WHICH CAUSED SOME STRIPPING OF THE BONE. A SIZE #10 IMPLANT WAS THEN USED WHICH WORKED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29844 KMI SUBTALAR MBA IMPLANT HRS KMI * 7338-9B

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other