BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRE PINK AT HARD

    MDR report key: 24901030 · Received April 16, 2026

    Report

    Report Number
    1937100-2026-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ORTHO SOLUTIONS LC DBA DYNAFLEX
    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 THE PATIENT'S APPLIANCE BROKE AND PATIENT SWALLOWED A SCREW. THE PATIENT WAS TAKEN TO AN URGENT CARE CENTER AND HAD A SCAN( IT IS UNKNOWN EXACTLY WAS PROCEDURE WAS CONDUCTED) PERFORMED TO TRY TO LOCATE THE SCREW. THE SCREW PASSED THROUGH THE PATIENT AND THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956483 RESPIRE PINK AT HARD OSA DEVICE LRK ORTHO SOLUTIONS LC DBA DYNAFLEX RESPIRE PINK AT R399961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention