BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 22546666 · Received July 18, 2025

    Report

    Report Number
    3008792120-2025-00003
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 12, 2025
    Report Date
    September 18, 2025
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT HAD A SUCCESSFUL HYOID SUSPENSION WITH THE ENCORE SYSTEM. LATER, THE PATIENT FELT A FELT PAIN IN THE LOCATION OF THE HYOID SUSPENSION. THE PAIN RESOLVED. SLEEP CONTINUES TO BE MUCH IMPROVED. PRESUMABLE THE PATIENT TOOK MEDICATION TO ALLEVIATE THE PAIN.

    Description of Event or Problem · 0

    THE PATIENT HAD A SUCCESSFUL HYOID SUSPENSION WITH THE ENCORE SYSTEM. LATER, THE PATIENT FELT A "POP" AND FELT PAIN IN THE LOCATION OF THE HYOID SUSPENSION. IMAGING INDICATED THAT THE HYOID BONE HAD FRACTURED. THE PATIENT HAD NO ISSUES FROM THE FRACTURED HYOID BONE. PRESUMABLE THE PATIENT TOOK MEDICATION TO ALLEVIATE THE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400449 ENCORE SYSTEM INTRAORAL DEVICE FOR SNORING AND SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other