BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTO TALARIS PROSTHESIS

    MDR report key: 6140575 · Received December 2, 2016

    Report

    Report Number
    3000931034-2016-00210
    Event Type
    Injury
    Date Received
    December 2, 2016
    Report Date
    November 15, 2016
    Manufacturer
    TORNIER S.A.S.
    Product Code
    HSN
    PMA / PMN Number
    K130533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FAILURE OF BONE INGROWTH INTO THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791346 SALTO TALARIS PROSTHESIS ANKLE PROSTHESIS HSN TORNIER S.A.S. NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other