BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSOMNUS EVO SLEEP AND SNORE DEVICE

    MDR report key: 21612792 · Received March 14, 2025

    Report

    Report Number
    3013116677-2025-00001
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    January 3, 2025
    Report Date
    March 14, 2025
    Manufacturer
    PROSOMNUS SLEEP TECHNOLOGIES
    Product Code
    LRK
    UDI-DI
    00863039000485
    PMA / PMN Number
    K202529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF DEVICE HISTORY RECORDS INCLUDING PRODUCTION RELATED RECORDS INDICATES NO DISCREPANCY OR PRODUCT RELATED PROBLEM. THE DESIGN FILE WAS ALSO REVIEWED AND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION AND PRESCRIPTION. THE FINISHED DEVICE PASSED THE PROSOMNUS QUALITY STANDARD AT FINAL QUALITY CONTROL FOR FIT AND FINISH. THE POSSIBILITY EXISTS THAT THE PATIENT'S PRE-EXISTING CONDITION OF BRUXISM AND PREVIOUS ROOT CANAL MAY HAVE CONTRIBUTED TO THE TOOTH FRACTURE IN COMBINATION WITH DEVICE USE. THE PRESCRIBING DENTIST OFFICE ADVISED THEY HAD COMMUNICATED VIA INFORMED CONSENT RECORDS THAT THERE CAN BE ISSUES WITH DEVICE USE. OUR PRODUCT RELATED DOCUMENTATION, USER MANUAL & INSTRUCTIONS FOR USE, CONTAIN WARNINGS OF TOOTH MOVEMENT, CHANGES IN DENTAL OCCLUSION, GINGIVAL OR DENTAL SORENESS. THE SAME PRESCRIBING DENTIST HAD ADJUSTED THE PROSOMNUS EVO SLEEP AND SNORE DEVICE TO A MORE PASSIVE FIT AFTER THE PLACEMENT OF THE DENTAL IMPLANT. THE PATIENT IS CURRENTLY USING THE SAME DEVICE, PROSOMNUS EVO SLEEP AND SNORE DEVICE, WHICH WAS PROVIDED TO HIM EARLIER.

    Description of Event or Problem · 0

    PROSOMNUS SLEEP TECHNOLOGIES WAS MADE AWARE OF AN INCIDENT OF ROOT CANALED TOOTH BREAKAGE ON (B)(6) 2025 THAT OCCURRED ON (B)(6) 2025. PATIENT BROKE TOOTH # 9, PRESUMABLY AT THE GUMLINE, DUE TO EXCESS PRESSURE THE DAY AFTER DEVICE DELIVERY. HE WENT TO HIS GENERAL DENTIST AND IT [TOOTH # 9] WAS EXTRACTED AND AN IMPLANT WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546217 PROSOMNUS EVO SLEEP AND SNORE DEVICE MANDIBULAR ADVANCEMENT DEVICE LRK PROSOMNUS SLEEP TECHNOLOGIES 1450 00863039000485

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other