BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS

    MDR report key: 5112338 · Received September 29, 2015

    Report

    Report Number
    3005670412-2015-00009
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THREE RIBLOC U PLUS PLATES WERE SUCCESSFULLY IMPLANTED TO TREAT RIB FRACTURES. THE PATIENT DEVELOPED SEROMA AND DEGRADATION OF SOFT TISSUE IN THE AREA OF ONE OF THE PLATES, DESPITE THE BONE FULLY HEALING. ON (B)(6) 2015, AS A PRECAUTION AGAINST FURTHER COMPLICATIONS, THE SURGEON EXPLANTED ONE OF THE PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642633 RIBLOC U PLUS PLATE, FIXATION, BONE HRS ACUTE INNOVATIONS, LLC RBL1301

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention