BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 14214779 · Received April 26, 2022

    Report

    Report Number
    3008650117-2022-00045
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 26, 2022
    Manufacturer
    PARAGON 28, INC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A SURGICAL PROCEDURE A SCREW WAS IMPLANTED AND FOUND TO BE BENT ONLY AFTER IMPLANTATION. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1494275 MONSTER SCREW SYSTEM MINI MONSTER HEADLESS, SHORT THREAD, 2.5 X 42MM HWC PARAGON 28, INC P20-525-042S

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention