BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC

    MDR report key: 4109772 · Received September 12, 2014

    Report

    Report Number
    3005670412-2014-00002
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    April 24, 2013
    Report Date
    September 12, 2014
    Manufacturer
    ACUTE INNOVATIONS, LLC
    Product Code
    HRS
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT TOWARD THE END OF A SURGICAL CASE TO PROVIDE INTERNAL FIXATION FOR 13 RIB FRACTURES A LUNG LACERATION WAS OBSERVED. THE SURGEON HYPOTHESIZED THAT THE LACERATION COULD HAVE OCCURRED DUE TO A SURGICAL INSTRUMENT, SCREW PROTRUSION OR FRACTURED RIB ENDS. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION SINCE THE SOURCE OF THE LUNG LACERATION COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566666 RIBLOC RIB SCREW HRS ACUTE INNOVATIONS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention