BEUDAMED
    FDA Adverse Event Summary report: N

    MINI MAXLOCK EXTREME

    MDR report key: 5213569 · Received November 10, 2015

    Report

    Report Number
    3004983210-2015-00052
    Date Received
    November 10, 2015
    Date of Event
    September 30, 2015
    Report Date
    November 20, 2015
    Manufacturer
    TORNIER INC.
    Product Code
    HRS
    PMA / PMN Number
    K121437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE MINI MTP PLATE (MXM-002-MTP-L) WAS BROKEN DIRECTLY IN HALF. RIGHT AT THE LASER LINE ON THE PLATE FOR THE JOINT. WE TRIED TO REMOVE THE SCREWS AND BROKE A BUNCH OF DRIVERS. WE WERE ABLE TO GET ONE HALF OF THE PLATE OUT. THE OTHER HALF WE COULD NOT GET THE SCREWS OUT. HE HAD TO SAW THE PLATE IN PIECES TO REMOVE THE PLATE AND SCREWS. WE THEN REVISED IT USING A MAX LOCK MTP PLATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745502 MINI MAXLOCK EXTREME MTP PLATE LEFT HRS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention