BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTO TALARIS TOTAL ANKLE PROSTHESIS

    MDR report key: 3940191 · Received June 18, 2014

    Report

    Report Number
    9610667-2014-00011
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    August 21, 2011
    Report Date
    May 21, 2014
    Manufacturer
    TORNIER SAS
    Product Code
    HSN
    PMA / PMN Number
    K060544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE.

    Description of Event or Problem · 1

    BONE CYST - REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356699 SALTO TALARIS TOTAL ANKLE PROSTHESIS NONE HSN TORNIER SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention