BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRE PINK AT HARD/SOFT

    MDR report key: 25127481 · Received May 8, 2026

    Report

    Report Number
    1937100-2026-00003
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 8, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ORTHO SOLUTIONS LC
    Product Code
    LRK
    PMA / PMN Number
    K192127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 TWICE. THE PATIENT SWALLOWED THE SCREW. THE PATIENT REQUIRED AN X-RAY TO CONFIRM THAT THE SCREW HAD NOT BEEN ASPIRATED. THE PATIENT WAS NOT INJURED. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201113 RESPIRE PINK AT HARD/SOFT OSA DEVICE LRK ORTHO SOLUTIONS LC RESPIRE PINK AT R372257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention