BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI

    MDR report key: 8084385 · Received November 19, 2018

    Report

    Report Number
    3007289093-2018-00029
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 19, 2018
    Manufacturer
    EXTREMITY MEDICAL, LLC.
    Product Code
    HRS
    PMA / PMN Number
    K180808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST DISASSEMBLED INTRAOPERATIVELY AND COULD NOT BE TARGETED WITH THE LAG SCREW. POST WAS REMOVED AND REPLACED WITH A 3.5MM LOCKING SCREW. CASE PROCEEDED WITHOUT ANY ISSUE. NO IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923128 OMNI PLATE SYSTEM HRS EXTREMITY MEDICAL, LLC. M88595

    Patients

    Seq Age Sex Outcome Treatment
    1