BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSOMNUS EVO SLEEP AND SNORE DEVICE

    MDR report key: 23514401 · Received November 10, 2025

    Report

    Report Number
    3013116677-2025-00003
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    September 13, 2025
    Report Date
    November 10, 2025
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000485
    PMA / PMN Number
    K202529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 09-16-2025, PROSOMNUS RECEIVED A COMPLAINT REGARDING POST JUNCTION BREAKAGE OF THE SUBJECT DEVICE. A REMAKE/REPLACEMENT OF THE LOWER ARCH WAS SHIPPED ON 09-25-2025 UNDER WARRANTY. ON 10-14-2025, PROSOMNUS RECEIVED VOLUNTARY MEDWATCH REPORT 5176206 FROM THE FDA AND SUBSEQUENTLY CONTACTED THE PRESCRIBER'S OFFICE TO OBTAIN FURTHER INFORMATION. NO PATIENT HARM FROM POST JUNCTION BREAKAGE WAS REPORTED IN EITHER THE MEDWATCH REPORT OR THE DOCTOR'S FILLED-OUT INVESTIGATION FORM. VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THE BREAKAGE OF THE LOWER ARCH'S POST JUNCTION AND REVEALED LIKELY TEETH IMPRINTS ON THE OCCLUSAL PLANE, CONSISTENT WITH THE MARKINGS OBSERVED IN THE DOCTOR'S PHOTOS. THE IMPRINTS SUGGEST THAT THE DEVICE USED INCORRECTLY, AND THAT UNFORESEEN STRESS AND FORCES WERE APPLIED TO THE DEVICE ITSELF. THE DEVICE IS DESIGNED TO BE USED AS A PAIR, AND THIS TYPE OF DEVICE MISUSAGE WOULD CONTRIBUTE TO PREMATURE DEVICE FAILURE. THE DOCTOR CONFIRMED THAT THE DEVICE BROKE DURING SLEEP. ALTHOUGH THE PATIENT DENIED BRUXISM, THE IMPRINTS INDICATE SIGNIFICANT FORCE DURING USE, SUPPORTING BRUXISM/CLENCHING AS A POTENTIAL CONTRIBUTING FACTOR. INITIAL PERFORMANCE TESTING INDICATES THAT EXTREME FORCE, EITHER ACUTE OR REPETITIVE, IS REQUIRED TO DISLODGE OR BREAK A POST JUNCTION. REVIEW OF THE DEVICE HISTORY RECORDS AND DESIGN FILES CONFIRMED THE DEVICE WAS MANUFACTURED PER SPECIFICATIONS AND PRESCRIBED CONFIGURATIONS. THE SCANS, CONFIRMED ACCURATE BY THE PHYSICIAN, REVEAL A MILD MIDLINE SHIFT TO THE PATIENT'S LEFT, POSSIBLY CAUSING RIGHTWARD LATERAL PRESSURE ON THE LEFT POST. EVEN THOUGH THE MIDLINE MEASUREMENTS OF THESE SCANS REMAIN WITHIN OUT INTERNAL ACCEPTABLE PROCEDURAL LIMITS, IT IS VERY POSSIBLE THAT THE CLINICAL BIT POSITION FOR THIS PATIENT MAY HAVE BEEN INACCURATELY CAPTURED DURING THE SCAN, CONTRIBUTING TO THE ISSUE. WHILE MULTIPLE POTENTIAL CONTRIBUTING FACTORS (SUCH AS PREMATURE DEVICE WEAR, BRUXISM, AND BITE DISCREPANCIES) ARE EVIDENT, NONE CAN BE CONFIRMED AS THE SOLE CAUSE. THEREFORE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. OUR DEVICE-RELATED RISK MANAGEMENT REPORT OUTLINES THIS SITUATION, POTENTIAL HARM, AND MITIGATION STRATEGIES FOR SUCH EVENTS, WHICH ARE WITHIN ACCEPTABLE RISK LEVELS. AS PART OF OUR DUE DILIGENCE, WE ARE REPORTING THIS INCIDENT IN ACCORDANCE WITH 21 CFR 803.

    Description of Event or Problem · 0

    PROSOMNUS SLEEP TECHNOLOGIES RECIEVED MEDWATCH # MW5176206 DIRECTLY FROM THE FDA/CDRH ON (B)(6) 2025; BELOW IS THE EVENT DESCRIPTION RE-COPIED FROM THE REPORT. PROSOMNUS ORAL MANDIBULAR ADVANCEMENT TRAY HAD A PIECE BREAK OFF. IT IS A SET OF TWO TRAYS THAT SIT OVER THE TEETH AND TREAT SLEEP APNEA BY ADVANCING THE JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525677 PROSOMNUS EVO SLEEP AND SNORE DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1454 00863039000485

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention