BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS 75MM RIB PLATE

    MDR report key: 5881003 · Received August 16, 2016

    Report

    Report Number
    3005670412-2016-00008
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 8, 2016
    Report Date
    August 16, 2016
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    UDI-DI
    10814493010388
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2016, FIVE RIB PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. THE PATIENT DEVELOPED AN INFECTION AND ALL FIVE PLATES WERE REMOVED ON (B)(6) 2016. PLATES WERE NOT RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532888 RIBLOC U PLUS 75MM RIB PLATE PLATE, FIXATION, BONE HRS ACUTE INNOVATIONS, LLC RBL1302 10814493010388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention