BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE MPJ VLC GRIDLOCK PLATE LEFT

    MDR report key: 6337817 · Received February 16, 2017

    Report

    Report Number
    3007420745-2016-00004
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    July 26, 2016
    Report Date
    December 6, 2016
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    PMA / PMN Number
    K160177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETUNED TO MANUFACTURER.

    Description of Event or Problem · 1

    DR. (B)(6) NOTIFIED REP, (B)(4) OF A BROKEN PETITE MPJ PLATE (LEFT) AFTER THE PATIENT'S ONE-MONTH POST-OP VISIT. THE SURGEON NOTED THAT A FUSION HAD NOT YET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118575 PETITE MPJ VLC GRIDLOCK PLATE LEFT PLATE, FIXATION, BONE HRS TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention