BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE WITH GL HINGE

    MDR report key: 22731516 · Received August 6, 2025

    Report

    Report Number
    3011649314-2025-00890
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Report Date
    January 2, 2026
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K233434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE DEVICE WAS RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE EVALUATION IS PENDING. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED; FOLLOWING IS THE DEVICE ANALYSIS CONCLUSION: 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 PRODUCT WAS RETURNED, BUT NOT IN THE ORIGINAL CASE. THE DEVICE WAS VISUALLY INSPECTED AND THE FOLLOWING WAS FOUND: ROUGHNESS - THE FLANGE WAS SMOOTH; INTERNAL/EXTERNAL SURFACES WERE SMOOTH. CRACK - A PIECE OF THE TRAY WAS BROKEN OFF AND ONE SIDE OF THE HINGE WAS BROKEN OFF OF THE DEVICE. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATE. DISCOLORATION - THE DEVICE WAS TRANSPARENT AND HAD DISCOLORATION. GENERAL CLEANLINESS - THE RETURNED DEVICE APPEARED TO BE NOT CLEAN. ROOT CAUSE DESCRIPTION. THE POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO THE EXCESSIVE BRUXISM WHICH COULD CAUSE THE SCREWS TO BECOME LOOSE AND FALL OFF OF THE DEVICE AND ALSO CAUSE THE TRAY 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." MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED A SILENT NITE GL HINGE HAS A METAL SPRING CONNECTOR THAT BROKE OFF AND SOME AREAS ARE CHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556447 SILENT NITE WITH GL HINGE SLEEP APPLIANCE LRK PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown