BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE GL HINGE

    MDR report key: 23168654 · Received September 29, 2025

    Report

    Report Number
    3011649314-2025-00117
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Report Date
    January 12, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K233434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS NOT YET BEEN RETURNED. AN INVESTIGATION WILL BE CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED. MANUFACTURER REFERENCE: (B)(4)

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9. THE PRODUCT WAS IN GLIDEWELLS POSSESSION BUT DID NOT TRANSFER TO THE INVESTIGATION SITE AND IS PRESUMED TO BE LOST. THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS. THE PRODUCTION RECORD FOR THE CASE NUMBER WAS REVIEWED, AND NO ANOMALIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. STOCK PRODUCT REVIEWED RESULTS. NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS. THE REPORTED PRODUCT HAS NOT BEEN RETURNED TO THE COMPLAINT HANDLING TEAM TO DATE THEREFORE AN ANALYSIS OF THE PHYSICAL PRODUCT COULD NOT BE PERFORMED. ROOT CAUSE DESCRIPTION. THE ROOT CAUSE COULD NOT BE EXPLICITLY DETERMINED. A POTENTIAL ROOT CAUSE MAY BE DUE TO THE EXCESSIVE FORCE FROM BRUXISM WHICH COULD CAUSE THE ROD TO FRACTURE OFF OF THE DEVICE. IFU-012652 REV 1 (SILENT NITE WITH GLIDEWELL HINGE - PATIENT INSTRUCTION FOR USE - MULTI-LANGUAGE) CONTAINS THE FOLLOWING STATEMENT IN THE PRECAUTIONS SECTION: "YOUR DENTIST WILL CONSIDER YOUR MEDICAL HISTORY, INCLUDING ALLERGIC REACTIONS, HISTORY OF ASTHMA, BREATHING, OR RESPIRATORY DISORDERS, OR OTHER RELEVANT HEALTH PROBLEMS, AND IF YOU HAVE THOSE, REFER YOU TO THE APPROPRIATE HEALTHCARE PROVIDER BEFORE PRESCRIBING THIS DEVICE." MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THE "ARM FRACTURED OFF MAXILLARY TRAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772342 SILENT NITE GL HINGE SLEEP APPLIANCE LRK PRISMATIK DENTALCRAFT, INC. SNGLHG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown