BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER

    MDR report key: 2627518 · Received January 8, 2010

    Report

    Report Number
    9610667-2010-00020
    Event Type
    Malfunction
    Date Received
    January 8, 2010
    Date of Event
    December 17, 2009
    Report Date
    January 8, 2010
    Manufacturer
    TORNIER INC.
    Product Code
    NDF
    PMA / PMN Number
    053408
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PT WITH A TORNIER FOOT FIXATION SYSTEM ORIGINALLY IMPLANTED ON (B)(6) 2008 PRESENTED FOR EVALUATION OF A SCREW BACKING OUT OF POSITION, BUT WAS OTHERWISE ASYMPTOMATIC. IT IS REPORTED THAT ONE OF THE FIXATION SCREWS WAS CLINICALLY CONFIRMED AS BACKING OUT OF POSITION AND ALSO THAT THE FIXATION PLATE HAD BROKEN. THE FIXATION SYSTEM, PLATE AND ALL SCREWS, WAS COMPLETELY REMOVED BY REVISION SURGERY ON (B)(6) 2009, WITHOUT DEVICE REPLACEMENT REQUIRED. NO ADDITIONAL ADVERSE PT EFFECT, OTHER THAN THE REVISION SURGICAL EVENT TO ALLOW EXPLANTATION, IS REPORTED TO HAVE OCCURRED. DEVICE SERIAL/LOT NUMBERS HAVE NOT BEEN IDENTIFIED. DEVICE RETURN FOR EVALUATION HAS BEEN REQUESTED AND MAY OCCUR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER PLATE, FIXATION, BONE NDF TORNIER INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R