BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE GL HINGE

    MDR report key: 22560927 · Received July 21, 2025

    Report

    Report Number
    3011649314-2025-00768
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Report Date
    December 19, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K233434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RETURNED, ANN INVESTIGATION WILL BE PERFORMED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    NO PHYSICAL DEVICE WAS RECEIVED. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, 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 EXCESSIVE BRUXISM WHICH HAVE CAUSED THE TRAYS TO FRACTURE. 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". THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A SILENT NITE APPLIANCE HAS FRACTURED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784229 SILENT NITE GL HINGE SLEEP APPLIANCE LRK PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown