BEUDAMED
    FDA Adverse Event Other Summary report: N

    RIBLOC RIB FRACTURE PLATING SYSTEM

    MDR report key: 2765516 · Received September 25, 2012

    Report

    Report Number
    3005670412-2012-00011
    Event Type
    Other
    Date Received
    September 25, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 24, 2012
    Manufacturer
    ACUTE INNOVATIONS
    Product Code
    HRS
    PMA / PMN Number
    K051410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER INVESTIGATION, FOLLOW UP REPORT 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 CODE: HRS HRS ACUTE INNOVATIONS RBP1104

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention