BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRE PINK AT MICRO HARD/SOFT

    MDR report key: 25191320 · Received May 15, 2026

    Report

    Report Number
    1937100-2026-00005
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 15, 2026
    Manufacturer
    ORTHO SOLUTIONS LC
    Product Code
    LRK
    PMA / PMN Number
    K192127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINT WAS RECEIVED THAT THE UPPER LEFT DOUBLE-PIVOT OF THE PINK AT MICRO BROKE FREE FROM THE ACRYLIC FOR A SECOND TIME. THE PATIENT WAS NOT INJURED. AFTER INSPECTING THE RETURNED DEVICE IT IS SUSPECTED THAT THE PATIENT IS A BRUXER AND A DIFFERENT DEVICE WOULD BE BETTER SUITED TO ALLOW MORE LATERAL MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429674 RESPIRE PINK AT MICRO HARD/SOFT OSA DEVICE LRK ORTHO SOLUTIONS LC RESPIRE PINK AT MICRO H/S R439773

    Patients

    Seq Age Sex Outcome Treatment
    1