BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXLOCK EXTREME SYSTEM Y PLATE

    MDR report key: 5739955 · Received June 21, 2016

    Report

    Report Number
    3004983210-2016-00016
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    October 21, 2015
    Report Date
    April 13, 2017
    Manufacturer
    TORNIER INC.
    Product Code
    HRS
    PMA / PMN Number
    K132591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED ON 10/07/2016.

    Additional Manufacturer Narrative · 1

    UPDATED TO REFLECT ADDITIONAL INFORMATION RECEIVED ON 03/09/2017.

    Description of Event or Problem · 1

    LETTER WAS RECEIVED FROM THE OFFICES OF (B)(6) LAW FIRM LLC READING: "PLEASE BE ADVISED THAT OUR OFFICE HAS BEEN RETAINED TO REPRESENT (B)(6) FOR THE DAMAGES SHE SUSTAINED AS A RESULT OF A DEFECTIVE HARDWARE DEVICE THAT WAS IMPLANTED IN TO HER FOOT. THE MEDICAL DEVICE WAS AN ORTHOHELIX LOCKING SCREW IMPLANT NUMBER MFT-002-Y. THE DEVICE WAS IMPLANTED OF (B)(6) 2012. WITHIN A YEAR MS (B)(6) STARTED FEELING DISCOMFORT IN THE AREA OF THE IMPLANT AND ALSO WAS FEELING ILL. ON (B)(6) 2015, (B)(6) UNDERWENT A PROCEDURE TO REMOVE THE HARDWARE. DURING THE SURGICAL PROCEDURE, IT WAS NOTED THAT THE HARDWARE WAS BROKEN IN MULTIPLE PLACES AND THAT THERE WAS A "VERY UNUSUAL COLOR EXUDATE NOT APPEARING TO BE AN INFECTION, BUT JUST A RUSTING MATERIAL ALMOST LIKE A RUSTY ORANGY, BROWNISH METAL RESIDUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392844 MAXLOCK EXTREME SYSTEM Y PLATE PLATES/SCREWS HRS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention