BEUDAMED
    FDA Adverse Event Other Summary report: N

    TORNIER

    MDR report key: 2670748 · Received August 29, 2011

    Report

    Report Number
    3004983210-2011-00005
    Event Type
    Other
    Date Received
    August 29, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 15, 2011
    Manufacturer
    TORNIER INC.
    Product Code
    KWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PT.

    Description of Event or Problem · 1

    AN IMPLANT SIZER WAS IMPLANTED INTO A PT. SIZER IS NOT APPROVED FOR IMPLANTATION. THE SIZER IS AN INSTRUMENT DESIGNED TO BE USED FOR DETERMINING THE PROPER IMPLANT SIZE AND TO THEN BE REMOVED AND REPLACED WITH AN IMPLANT. NO NEGATIVE PT IMPACT HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PRIMUS FLEXIBLE GREAT TOE SIZER SIZE 50 KWH TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1