BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE MPJ VLC GRIDLOCK PLATE LEFT

    MDR report key: 6529923 · Received April 28, 2017

    Report

    Report Number
    3007420745-2017-00007
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Date of Event
    March 17, 2017
    Report Date
    April 28, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    UDI-DI
    00812926025360
    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

    THE PATIENT REPORTED PAIN IN HER FOOT AND UPON X-RAYING THE SURGICAL SITE, IT WAS NOTICED THAT THE 300-52-005 PETITE PLATE THAT WAS PREVIOUSLY PLACED IN THE PATIENT WAS BROKEN. UPON FURTHER REVIEW THE DOCTOR NOTICED THE OSTEOTOMY SITE HAD CALCIFIED OVER BUT A FUSION DID NOT OCCUR. HE PREPARED THE JOINT AND RE-PLATED USING A 300-52-002 MPJ PLATE. THE DOCTOR USED A 4.0 SOLID CORE GRIDLOCK PLATING SYSTEM SCREW AS A LAG SCREW. THE DOCTOR MENTIONED THAT BONE PURCHASE WAS ACHIEVED AND ALL HOLES OF THE PLATE WERE FILLED WITH GRIDLOCK PLATING SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313106 PETITE MPJ VLC GRIDLOCK PLATE LEFT BONE PLATE HRS TRILLIANT SURGICAL, LTD 00812926025360

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention