BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUMERIS

    MDR report key: 9847653 · Received March 18, 2020

    Report

    Report Number
    3009532798-2020-00145
    Event Type
    Malfunction
    Date Received
    March 18, 2020
    Date of Event
    February 24, 2020
    Report Date
    March 18, 2020
    Manufacturer
    FX SOLUTIONS
    Product Code
    PHX
    PMA / PMN Number
    K163669
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    AS SURGEON WAS TIGHTENING DOWN BASEPLATE LOCKING SCREW SIZE 20 DURING REVERSE SURGERY ON (B)(6) 2020, THE SCREW HEAD FORMED CRACK DOWN THE MIDDLE. AS THEY ATTEMPTED TO REMOVE SCREW, CRACK WORSENED AND SURGEON WAS UNABLE TO SECURE A SCREWDRIVER INTO THE SCREW. SURGEON MADE DECISION TO LEAVE SCREW IN. SURGEON COMMUNICATED TO FIELD REPRESENTATIVE THAT THEY TOOK EXTRA PRECAUTIONS TO PREVENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314620 HUMERIS REVERSED SHOULDER PROTHESIS PHX FX SOLUTIONS N1935

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR