BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A.L.P.S. MVX

    MDR report key: 21049118 · Received December 31, 2024

    Report

    Report Number
    3012966183-2024-00025
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 21, 2024
    Report Date
    December 31, 2024
    Manufacturer
    TYBER MEDICAL
    Product Code
    HRS
    UDI-DI
    00196449015900
    PMA / PMN Number
    K232652
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD REVIEW RETURNED NO NONCONFORMITIES PRESENT WITHIN THE LOT THAT ARE RELATED TO THE NATURE OF THE EVENT. AT THE TIME OF RELEASE THE DEVICE MET RELEASE CRITERIA. DEVICE EVALUATION CONFIRMED THAT THE AFFECTED PLATE SLOT WAS WITHIN SPECIFICATION. THE NOTED SURGICAL DELAY RESULTED FROM REMOVING THE AFFECTED DEVICE. AT THE TIME OF THIS REPORT, THE ROOT CAUSE CANNOT BE ESTABLISHED WITH THE PROVIDED INFORMATION.

    Description of Event or Problem · 0

    SURGEON TRIED PUTTING IN SCREW INTO OBLONG HOLE TOWARDS TOP OF THE ANTEROLATERAL DISTAL TIBIA PLATE AND SCREW HEAD BROKE OFF FAIRLY EASILY. HE THEN PUT A SCREW IN JUST PROXIMAL TO THE FIRST AND SCREW HEAD PASSED THROUGH THE PLATE AND WAS STUCK UNDER PLATE. 2-HOUR SURGICAL DELAY NOTED AFTER SURGEON TRIED TO REMOVE BROKEN SCREW AND THE SCREW UNDER THE PLATE. SCREW WAS DISCARDED AND PLATE WAS RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134349 A.L.P.S. MVX ANTLATERAL TIB PLT 10H RT WIDE HRS TYBER MEDICAL 770714102 00196449015900

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Other