BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIBLOC RIB FRACTURE PLATING SYSTEM

    MDR report key: 2474255 · Received February 27, 2012

    Report

    Report Number
    3005670412-2012-00002
    Event Type
    Other
    Date Received
    February 27, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 22, 2012
    Manufacturer
    ACUTE INNOVATIONS
    Product Code
    HRS
    PMA / PMN Number
    K051410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT HAD FOUR PLATES INSTALLED ON (B)(6) 2011, DUE TO ACUTE TRAUMA. ON (B)(6) 2012, ONE BROKEN PLATE WAS REMOVED ALONG WITH THE 4 SCREWS USED TO INSTALL THE PLATE, AND THE FRACTURE WAS RE-PLATED. A SECOND TRAUMA IS SUSPECTED IN CAUSING THE PLATE BREAKAGE. UNDER INVESTIGATION, F/U REPORT WITH EVAL CODES WILL BE PROVIDED.

    Description of Event or Problem · 1

    PLATE REMOVAL DUE TO PLATE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIBLOC RIB FRACTURE PLATING SYSTEM RIB BONE PLATE, PRODUCT COD: HRS HRS ACUTE INNOVATIONS RBP1124 L1012004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention