BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE MPJ VLC GRIDLOCK PLATE LEFT

    MDR report key: 6337821 · Received February 16, 2017

    Report

    Report Number
    3007420745-2016-00005
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    December 13, 2016
    Report Date
    December 15, 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

    Description of Event or Problem · 1

    DURING THE PATIENTS 5 WEEK POST OPERATIONAL FOLLOW-UP, IT WAS DISCOVERED THAT THE PETITE MPJ VLC GRIDLOCK PLATE LEFT WAS BROKEN. THE BROKEN PLATE WAS CONFIRMED VIA X-RAY. THERE WAS NO COMPLAINT OF PAIN FROM THE PATIENT. AT THE POINT OF THE FOLLOW-UP, NO FUSION HAD OCCURRED. DOCTOR NOTED PATIENT NON-COMPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120619 PETITE MPJ VLC GRIDLOCK PLATE LEFT PLATE, FIXATION, BONE HRS TRILLIANT SURGICAL, LTD TSL003125

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention