BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE GL HINGE

    MDR report key: 20789195 · Received November 26, 2024

    Report

    Report Number
    3011649314-2024-00930
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 15, 2024
    Report Date
    October 3, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    LRK
    PMA / PMN Number
    K210694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT DEVICE HAS NOT YET BEEN SHIPPED BACK FOR ANALYSIS. UPON RECEIVING THE DEVICE AN INVESTIGATION WILL BE CONDUCTED. AT THE COMPLETION OF THE INVESTIGATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE ANALYSIS CONCLUSION. COMPLAINT HISTORY AND PRODUCT HISTORY RECORDS WERE REVIEWED; DOCUMENTATION INDICATES THE PRODUCT MET RELEASE CRITERIA. THE PROBABLE ROOT CAUSE OF THE EVENT HAS NOT YET BEEN IDENTIFIED. MANUFACTURER INTERNAL REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE 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 PROBABLE ROOT CAUSE FOR THIS FAILURE MAY BE DUE TO THE PATIENT'S MEDICAL HISTORY. PER THE REPORTED INFORMATION, THE PATIENT HAS A HISTORY OF BRUXISM. THE EXCESSIVE FORCE FROM BRUXISM COULD CAUSE THE ANCHOR AND SOCKET HINGE TO DETACH FROM 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

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE ANCHOR AND SOCKET HINGE CAME OUT OF THE SILENT NITE GL HINGE SLEEP APPLIANCE DEVICE. PER THE REPORT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR PERMANENT INJURY. IT WAS REPORTED THAT THE PATIENT DISCONTINUED THE USE OF THE DEVICE, AND NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453392 SILENT NITE GL HINGE SILENT NITE SLEEP APPLIANCE LRK PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male