BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE SLEEP APPLIANCE WITH THE GLIDEWELL HINGE

    MDR report key: 19885414 · Received August 1, 2024

    Report

    Report Number
    3011649314-2024-00609
    Event Type
    Malfunction
    Date Received
    August 1, 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
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CAPA 24-007. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    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 COULD BE DUE TO EXCESSIVE BRUXISM WHICH COULD HAVE CAUSED THE ATTACHMENT TO BREAK 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".

    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 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 COULD BE DUE TO EXCESSIVE BRUXISM WHICH COULD HAVE CAUSED THE ATTACHMENT TO BREAK 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" G3 DATE OF MANUFACTURE AND H6 CODINGS ARE UPDATED WITH REFERENCE TO THE COMPLAINT NUMBER: (B)(4).

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT A REMAKE OF THE APPLIANCE WAS REQUESTED AS IT WAS BROKEN. PER THE PROVIDER, THE ATTACHMENT BROKE OFF. THERE WAS NO PATIENT HARM OR INJURY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249257 SILENT NITE SLEEP APPLIANCE WITH THE GLIDEWELL HINGE DEVICE, ANTI-SNORING LRK PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male