BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE SLEEP APPLIANCE WITH THE GLIDEWELL HINGE

    MDR report key: 19672299 · Received July 3, 2024

    Report

    Report Number
    3011649314-2024-00491
    Event Type
    Malfunction
    Date Received
    July 3, 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
    WA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CAPA 24-005 SINCE THE DEVICE IS UNAVAILABLE FOR ANALYSIS AND THE DEVICE IS FABRICATED PER PHYSICIAN'S PRESCRIPTION (RX) ONLY, THE ROOT CAUSE OF THE EVENT IS UNDETERMINABLE. THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. IT IS UNKNOWN IF ANY MODIFICATIONS WERE PERFORMED ON THE DEVICE BY THE PROVIDER OR PATIENT. THE PRECAUTIONS IN THE INSTRUCTIONS FOR USE (IFU-012556_5) STATE "REGULAR DENTAL FOLLOW-UPS ARE RECOMMENDED TO REVIEW ANY SIDE EFFECTS, AND TO AVOID DEVICE BREAKAGE, [?]" ADDITIONAL INFORMATION WAS REQUESTED FROM THE REPORTER REGARDING THE EVENT, SHOULD ADDITIONAL INFORMATION BE RECEIVED RELEVANT TO THE COMPLAINT A SUPPLEMENTAL REPORT WILL BE FILED. MANUFACTURES INTERNAL REFERENCE NUMBER: (B)(4). RELATED TO MDR # 3011649314-2024-00490 / (B)(4) FOR THE 1ST REMAKE.

    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. OCK PRODUCT REVIEWED RESULTS NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION REFER TO CAPA 24-007 AND HHE 2024-001 FOR THE ROOT CAUSE.

    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. OCK PRODUCT REVIEWED RESULTS: NO STOCK PRODUCT WAS AVAILABLE FOR REVIEW SINCE THE DEVICE WAS FABRICATED PER PHYSICIAN'S PRESCRIPTION ONLY. INVESTIGATION METHODS/RESULTS: CUSTOMER DID NOT RETURN THE REPORTED DEVICE FOR INVESTIGATION TO DATE. HOWEVER, THE NON-VISUAL DEVICE INVESTIGATION HAS BEEN COMPLETED. ROOT CAUSE DESCRIPTION: REFER TO CAPA 24-007 AND HHE 2024-001 FOR THE ROOT CAUSE.

    Description of Event or Problem · 0

    THE COMPLAINT WAS RECEIVED VIA A SLEEP APPLIANCE REMAKE REPORT. IT WAS REPORTED THAT THIS REMAKE WAS DUE TO THE APPLIANCE BREAKING AGAIN. NO FURTHER INFORMATION WAS REPORTED. THE DATE OF EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564807 SILENT NITE SLEEP APPLIANCE WITH THE GLIDEWELL HINGE ANTI SNORING NIGHTGUARD LRK PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown