BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS 155MM RIB PLATE

    MDR report key: 5880987 · Received August 16, 2016

    Report

    Report Number
    3005670412-2016-00004
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    December 22, 2015
    Report Date
    August 16, 2016
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    UDI-DI
    10814493010401
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON APPROXIMATELY (B)(6) 2014, SEVEN RIBLOC U PLUS PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. ON (B)(6) 2015, 4 PLATES WERE REMOVED DUE TO PATIENT COMPLAINTS OF DISCOMFORT; 3 PLATES WERE LEFT IN PLACE. NONE OF THE PLATES REMOVED WERE RETURNED FOR INVESTIGATION, HOWEVER. IT WAS STATED THAT THERE WAS NOTHING WRONG WITH THE IMPLANTS (PLATES AND SCREWS) AND THERE WAS NO MENTION BY THE USER OF AN APPARENT INSTALLATION ERROR AND YET THE BONES HAD NOT HEALED AFTER BEING INSTALLED FOR 16 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533022 RIBLOC U PLUS 155MM RIB PLATE PLATE, FIXATION, BONE HRS ACUTE INNOVATIONS, LLC RBL1304 L1401054 10814493010401

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention