BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PETITE STEPPED MPJ VLC GRIDLOCK PLATE RIGHT

    MDR report key: 6598191 · Received May 30, 2017

    Report

    Report Number
    3007420745-2017-00011
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 10, 2017
    Report Date
    May 30, 2017
    Manufacturer
    TRILLIANT SURGICAL, LTD
    Product Code
    HRS
    PMA / PMN Number
    K130964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR HER 3 WEEK FOLLOW UP. AFTER TAKING AN X-RAY, THE DOCTOR SAW THAT THE IMPLANTED PETITE 1ST MPJ PLATE, RIGHT HAD BROKEN IN HALF. HE SAID THAT THE PATIENT WAS WALKING ON IT MORE THAN SHE SHOULD HAVE. THE PLATE WAS INITIALLY IMPLANTED ON (B)(6) 2017. ACCORDING TO THE SALES REPRESENTATIVE, DOCTOR USES AN INTERFRAG SCREW ON A CASE BY CASE BASIS. HE DID NOT CHOOSE TO USE AN INTERFRAG SCREW FOR THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380754 PETITE STEPPED MPJ VLC GRIDLOCK PLATE RIGHT BONE PLATE HRS TRILLIANT SURGICAL, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR