BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE L PLATE (LEFT) GRIDLOCK PLATING SYSTEM

    MDR report key: 6716715 · Received July 17, 2017

    Report

    Report Number
    3007420745-2017-00012
    Event Type
    Malfunction
    Date Received
    July 17, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 14, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    UDI-DI
    00812926025407
    PMA / PMN Number
    K130964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DOCTOR REMOVED A LARGE VLC "L" PLATE (LEFT) BECAUSE OF A NON-UNION. THE PLATE WAS CRACKED, ACCORDING TO THE REP. THE DOCTOR REMOVED THE PLATE WITHOUT ANY COMPLICATIONS. HE PERFORMED A REVISION LAPIDUS PROCEDURE AND USED A PARAGON 28 PLATE TO FINISH THE CASE. THE REP WAS NOT ABLE TO KEEP THE PLATE BECAUSE THE PATIENT REQUESTED TO KEEP IT. THE REP WAS NOT ABLE TO DETERMINE THE INITIAL IMPLANT DATE THOUGH IT WSA DETERMINED TO BE A YEAR TO A YEAR AND A HALF AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497000 LARGE L PLATE (LEFT) GRIDLOCK PLATING SYSTEM BONE PLATE, PRODUCT CODE: HRS HRS TRILLIANT SURGICAL, LTD 00812926025407

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR