BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 HOLE WIDE VLC GRIDLOCK PLATE

    MDR report key: 6563355 · Received May 12, 2017

    Report

    Report Number
    3007420745-2017-00009
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    April 13, 2017
    Report Date
    May 12, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    UDI-DI
    00812926022451
    PMA / PMN Number
    K130964
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED PAIN IN HER FOOT. THIS PATIENT HAD A LAPIDUS PROCEDURE COMPLETED ON (B)(6) 2016 WITH A 300-50-004 PLATE. THE DOCTOR TOOK X-RAYS AND COULD TELL A SCREW WAS BACKING OUT AND THE 300-50-004 PLATE WAS BROKEN INSIDE THE PATIENT. ON (B)(6) 2017, THE DOCTOR REMOVED THE 300-50-004 PLATE. SINCE THE BONE HAD NOT COMPLETELY HEALED AND THERE WAS NO FUSION, THE DOCTOR REPLATED THE SURGICAL SITE. NO OTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343873 4 HOLE WIDE VLC GRIDLOCK PLATE BONE PLATE HRS TRILLIANT SURGICAL, LTD 00812926022451

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention