BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEPTALIGN

    MDR report key: 21256330 · Received January 28, 2025

    Report

    Report Number
    3030653921-2024-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Manufacturer
    SPIRAIR, INC
    Product Code
    NHB
    UDI-DI
    00860011696308
    PMA / PMN Number
    K233569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HARDENED STEEL TROCAR TIP WAS BENT AT MID-SECTION. EXPECTED PHYSIOLOGIC CONDITIONS WOULD NOT BE EXPECTED TO APPLY THIS MUCH FORCE TO THE TROCAR TIP. PLEASE NOTE THAT THIS IS THE COMPANY'S FIRST EMDR SUBMISSION AND WAS UNAVOIDABLY DELAYED DUE TO THE SIGN-UP PROCESS.

    Description of Event or Problem · 0

    DURING DELIVERY OF THE IMPLANT, IT WAS NOTED THAT A PORTION OF THE DELIVERY DEVICE TIP HAD BROKEN OFF INTO THE CARTILAGE. THE PIECE WAS EASILY RETRIEVED PRIOR TO COMPLETION OF THE PROCEDURE. THERE WAS NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1605964 SEPTALIGN DELIVERY DEVICE - EAR, NOSE, AND THROAT SYNTHETIC POLYMER MATERIAL NHB SPIRAIR, INC FG-0032 1012172 00860011696308

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male