BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRE PINK AT HARD

    MDR report key: 25185492 · Received May 15, 2026

    Report

    Report Number
    1937100-2026-00004
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ORTHO SOLUTIONS LC
    Product Code
    LRK
    PMA / PMN Number
    K192127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER COMPLAINT WAS RECEIVED THAT A SCREW ON THE PATIENT'S DEVICE DETACHED AT NIGHT WHILE THE PATIENT WAS WEARING THE APPLIANCE. THE SCREW COULD NOT BE FOUND. THE PATIENT MAY HAVE SWALLOWED THE SCREW. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AT AN URGENT CARE OR EMERGENCY ROOM. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442229 RESPIRE PINK AT HARD OSA DEVICE LRK ORTHO SOLUTIONS LC RESPIRE PINK AT R404104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention