BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS

    MDR report key: 6522670 · Received April 26, 2017

    Report

    Report Number
    3005670412-2017-00003
    Event Type
    Injury
    Date Received
    April 26, 2017
    Report Date
    March 27, 2017
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    UDI-DI
    10814493010371
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED SEPSIS AND PLATE BECAME DETACHED. REVISION SURGERY PERFORMED TO TREAT INFECTION AND REMOVE 3 PLATES. PATIENT WAS RE-PLATED WITH ANTERIOR RIB PLATES. REPORT 1 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305549 RIBLOC U PLUS RIBLOC U PLUS 50MM RIB PLATE HRS ACUTE INNOVATIONS, LLC RBL1301 L1602001 10814493010371

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention