BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENIO 2.1 SYSTEM

    MDR report key: 25244088 · Received May 21, 2026

    Report

    Report Number
    3017191859-2026-00017
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 21, 2026
    Manufacturer
    NYXOAH S.A.
    Product Code
    MNQ
    PMA / PMN Number
    P240024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXHIBITED SLIGHT UNILATERAL TONGUE RETRACTION WITH SATISFACTORY PROTRUSION ON THE CONTRALATERAL SIDE. FOLLOWING CLINICAL EVALUATION, THE PATIENT UNDERWENT SUCCESSFUL REVISION SURGERY ON (B)(6) 2026. DEVICE ACTIVATION IS SCHEDULED FOR ON (B)(6) 2026. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314382 GENIO 2.1 SYSTEM GENIO 2.1 SYSTEM, MNQ NYXOAH S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1