BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOMNUS EVO SLEEP AND SNORE DEVICE

    MDR report key: 24111914 · Received January 19, 2026

    Report

    Report Number
    3013116677-2026-00001
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    November 25, 2025
    Report Date
    January 19, 2026
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000485
    PMA / PMN Number
    K202529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 11-11-2025, PROSOMNUS SLEEP TECHNOLOGIES RECEIVED A COMPLAINT REGARDING LOOSE RETENTION OF THE LOWER ARCH. A REMAKE OF THE LOWER ARCH WAS INITIATED BEFORE PROSOMNUS BECAME AWARE OF THE POST-JUNCTION BREAKAGE ON THE SAME LOWER ARCH, REPORTED ON 11-25-2025, AND BEFORE RECEIVING THE VOLUNTARY FDA REPORT RECEIVED ON 01-08-2026. PROSOMNUS CONTACTED THE PRESCRIBER'S OFFICE TO OBTAIN FURTHER INFORMATION, AND THE COMPLETED INVESTIGATION FORM INDICATED NO PATIENT HARM AND DID NOT REQUIRE ANY ADDITIONAL MEDICAL INTERVENTION ASSOCIATED WITH THE POST-JUNCTION BREAKAGE. PROSOMNUS CONTACTED THE PRESCRIBER'S OFFICE TO OBTAIN FURTHER INFORMATION. THE COMPLETED PROSOMNUS PATIENT COMPLAINT INVESTIGATION FORM INDICATED THAT A PORTION OF THE TRAY REPORTEDLY BROKE IN THE PATIENT'S MOUTH DURING SLEEP. THE PATIENT STATED THAT HE ALMOST CHOKED. THE FORM ALSO DOCUMENTED THAT THE DEVICE DID NOT CAUSE PATIENT HARM AND DID NOT REQUIRE ADDITIONAL MEDICAL INTERVENTION. THE DEVICE WAS BEING USED ACCORDING TO THE INSTRUCTIONS FOR USE. THE PATIENT WAS EXHIBITING BRUXISM OR CLENCHING BEHAVIOR AND HAS BEEN DIAGNOSED WITH TEMPOROMANDIBULAR DISORDER. THIS INFORMATION GUIDED THE INTERNAL ASSESSMENT AND DECISION PATHWAYS TO NOT REPORT AT THAT TIME. ON 11-26-2025, PROSOMNUS RECEIVED AN ADDITIONAL COMPLAINT REGARDING LOOSE RETENTION OF THE CORRESPONDING UPPER ARCH. INTERNAL REVIEW OF THE INITIAL BITE SCAN IDENTIFIED POSSIBLE CONTRIBUTING FACTORS, INCLUDING SHORT CLINICAL CROWNS WITH MINIMAL UNDERCUT AND A LARGE VERTICAL OPENING. THESE FACTORS MAY REDUCE RETENTION, INCREASE MUSCULAR LOADING, AND ELEVATE STRESS AT THE POST-JUNCTION. THE PRESCRIBER RECOMMENDED THE USE OF ELASTIC BANDS TO THE PATIENT FOR RETENTION IMPROVEMENT BUT DID NOT FULLY RESOLVE THE ISSUE. PROSOMNUS COMMUNICATED WITH THE PRESCRIBER'S OFFICE AND THE PATIENT TO DISCUSS OPPORTUNITIES FOR IMPROVEMENT AND OFFERED THE PATIENT A NEW BITE SCAN TO SUPPORT A FULL SERIES REPLACEMENT, BASED ON THE POSSIBILITY THAT THE PATIENT'S BITE POSITION HAD CHANGED. COMPARATIVE ANALYSIS OF THE ORIGINAL AND UPDATED BITE SCANS DEMONSTRATED CHANGES IN BITE POSITION BOTH LATERALLY AND VERTICALLY. HISTORICAL DATA INDICATE THAT CHANGES IN BITE POSITION MAY CONTRIBUTE TO CERTAIN TYPES OF DEVICE STRESS, INCLUDING STRESS AT THE POST-JUNCTION. UPON THE PATIENT RECEIVING THE NEW DEVICES ON 1-06-2026, THE AFFECTED DEVICE AND ORIGINAL FULL SERIES WERE RETURNED, AND THE RMA WAS RECEIVED ON 01-13-2026. PROSOMNUS PROVIDES A 3-YEAR WARRANTY FROM THE DATE OF MANUFACTURE OF THE INITIAL DEVICE, AND REPLACEMENT DEVICES WERE ISSUED IN ACCORDANCE WITH THIS POLICY. AFTER RECEIVING THE RMA, ALL PARTS OF THE DEVICE WERE CONFIRMED TO BE COMPLETE AND WITHOUT EVIDENCE OF ADDITIONAL BREAKAGE. VISUAL INVESTIGATION FOUND NO SIGNS OF PREMATURE WEAR. PROSOMNUS REASSURED THE PATIENT THAT THE RETURNED DEVICE WOULD BE PRESERVED IN ITS RECEIVED CONDITION, WOULD NOT BE SUBJECTED TO TESTING THAT COULD ALTER ITS STATE, AND WOULD NOT BE DISPOSED OF DURING THE INVESTIGATION. REVIEW OF 2025 COMPLAINTS INDICATES THAT POST-JUNCTION BREAKAGES ACCOUNTED FOR (B)(4) OF UNITS IN SERVICE DURING SAME SALES PERIOD. DEVICE-RELATED RISK MANAGEMENT REPORTS ADDRESSED THIS TYPE OF SITUATION, POTENTIAL HARM, AND THE MITIGATION STRATEGIES ARE IN PLACE. CURRENT RISK LEVELS REMAIN WITHIN ACCEPTABLE RISK LEVELS. AS PART OF OUR DUE DILIGENCE, PROSOMNUS SLEEP TECHNOLOGIES IS REPORTING THIS INCIDENT IN ACCORDANCE WITH 21 CFR 803.

    Description of Event or Problem · 0

    PROSOMNUS SLEEP TECHNOLOGIES RECEIVED VOLUNTARY MEDWATCH REPORT MW5180513 DATED JANUARY 8TH, 2026, FROM US FDA / CDRH; BELOW IS THE EVENT OR PROBLEM STATEMENT VERBATIM EXTRACTED FROM THAT REPORT. "A JAGGED FRAGMENT BROKE OFF OF MY PROSOMNUS SLEEP APNEA DEVICE WHILE I WAS SLEEPING AND WAS LOOSE IN MY MOUTH. I WAS ABLE TO WAKEN AND RETRIEVE THE FRAGMENT BEFORE SUCKING IT INTO MY AIRWAY. I HAVE NOT BEEN ABLE TO SLEEP WELL SINCE THE INCIDENT DUE TO DISTRESS AND MENTAL ANGUISH OVER THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172723 PROSOMNUS EVO SLEEP AND SNORE DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1450 N/A 00863039000485

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention