BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBLOC U PLUS RIB PLATE

    MDR report key: 7777526 · Received August 13, 2018

    Report

    Report Number
    3005670412-2018-00005
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 4, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ACUTE INNOVATIONS LLC
    Product Code
    HRS
    UDI-DI
    10814493010388
    PMA / PMN Number
    K113318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PLATED APPROXIMATELY ONE YEAR PRIOR. PATIENT COMPLAINED OF LIMITED FUNCTION DUE TO PREVIOUS RIB SURGERY. SURGEONS DETERMINED PLATING CAUSE OF LIMITED FUNCTION. TWO PLATES REMOVED. REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618283 RIBLOC U PLUS RIB PLATE RIB PLATE HRS ACUTE INNOVATIONS LLC RIBLOC U PLUS 10814493010388

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention