BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI MAXLOCK EXTREME PLATE

    MDR report key: 5257361 · Received December 1, 2015

    Report

    Report Number
    3004983210-2015-00058
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    November 22, 2015
    Report Date
    November 5, 2015
    Manufacturer
    TORNIER INC.
    Product Code
    HRS
    PMA / PMN Number
    K121437
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: "BROKEN MINI MTP PLATE, MXM-002-MTP-L OR -R. BROKE ABOUT 6 MONTHS POST-OP. SURGEON WAS DR. (B)(6). NO FUSION. PLATE WAS REMOVED. PLATE WAS IMPLANTED ON (B)(6) 2015."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789644 MINI MAXLOCK EXTREME PLATE FIXATION PLATES AND SCREWS HRS TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention