BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCORE SYSTEM

    MDR report key: 25124891 · Received May 8, 2026

    Report

    Report Number
    3008792120-2026-00002
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SIESTA MEDICAL, INC.
    Product Code
    ORY
    UDI-DI
    0086221100206
    PMA / PMN Number
    K213159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PHYSICIAN TREATED THE PATIENT WITH A HYOID SUSPENSION USING THE ENCORE SYSTEM. THE PATIENT LATER DEVELOPED AN INFECTION IN THE UPPER INCISION SITE OF THE BONE ANCHOR PLACEMENT. THE PATIENT WAS GIVEN A COURSE OF ANTIBIOTICS AND A LAYERED CLOSURE WAS MADE TO ISOLATE THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31428 ENCORE SYSTEM INTRAORAL DEVICE FOR SNORING OR SLEEP APNEA ORY SIESTA MEDICAL, INC. FG0002 0086221100206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R