BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC 10MM X 46MM RIB PLATE

    MDR report key: 5880988 · Received August 16, 2016

    Report

    Report Number
    3005670412-2016-00005
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    April 29, 2016
    Report Date
    August 16, 2016
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    UDI-DI
    10814493010029
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ORIGINALLY PLATED (B)(6) 2013. REVISION SURGERY WAS PERFORMED TO REMOVE PLATE DUE TO PATIENT PAIN AND DISCOMFORT. NO DEVICE DEFICIENCY IS ALLEGED. PLATE WAS NOT RETURNED FOR ANAYLSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533025 RIBLOC 10MM X 46MM RIB PLATE PLATE, FIXATION, BONE HRS ACUTE INNOVATIONS, LLC RBP1102 10814493010029

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention