BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE GL HINGE

    MDR report key: 20730475 · Received November 19, 2024

    Report

    Report Number
    3011649314-2024-00899
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 30, 2024
    Report Date
    October 11, 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 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. 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 WAS EVALUATED, THE 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 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 - NO MAJOR CRACK WAS FOUND. DELAMINATION - LAYERS WERE INTACT AND DID NOT SEPARATE. DISCOLORATION - THE DEVICE WAS CLEAR AND TRANSPARENT. GENERAL CLEANLINESS - THE RETURNED DEVICE APPEARED TO BE CLEAN, FREE OF DEBRIS OR FOREIGN PARTICLES. IT WAS OBSERVED THAT A SIDE OF THE ROD WAS DETACHED FROM THE DEVICE AND FRACTURES WERE ALSO OBSERVED ON THE TRAY. 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 ROD TO BECOME LOOSE AND HAVE THE TRAY FRACTURED. 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).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INCORRECT INFORMATION. THE FOLLOWING CORRECTION HAS BEEN UPDATED IN THIS REPORT. CORRECTED INFORMATION G3 (DATE RECEIVED BY MANUFACTURER) THAT WAS NOT CAPTURED IN THE PERVIOUS REPORT WAS CORRECTED IN THIS REPORT. CORRECTED INFORMATION H6 (ADVERSE EVENT PROBLEM) THAT WAS NOT CAPTURED IN THE PERVIOUS REPORT WAS CORRECTED IN THIS REPORT. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE TRAY FRACTURED, AND THE TELESCOPIC ROD IS LOOSE ON A SILENT NITE GL HINGE SLEEP APPLIANCE DEVICE. PER THE REPORT THE PATIENT HAS HEAVY BRUXISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997381 SILENT NITE GL HINGE SILENT NITE SLEEP APPLIANCE LRK PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male