BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILENT NITE 3D

    MDR report key: 20898387 · Received December 10, 2024

    Report

    Report Number
    3011649314-2024-00943
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 19, 2024
    Report Date
    October 15, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC
    Product Code
    LRK
    PMA / PMN Number
    K183270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED. SHOULD THE DEVICE BE RETURNED, AN INVESTIGATION WILL BE COMPLETED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF THE INVESTIGATION. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: CASE# (B)(4) WAS MANUFACTURED WITH GLIDEWELL TUFFSPLINT APPLIANCE RESIN LOT # 6222504. THE MANUFACTURING ROUTER WAS REVIEWED FOR GLIDEWELL TUFFSPLINT APPLIANCE RESIN LOT # 6222504 AND THERE WAS NO EVIDENCE DISCOVERED TO INDICATE THAT A PRODUCT DEFECT OR NON-CONFORMITY CONTRIBUTED TO THE ISSUE. THE PART MET ALL THE CRITERIA CALLED FOR IN THE PRODUCTION ROUTER. 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 CUSTOMER HAS NOT RETURNED THE REPORTED DEVICE FOR REVIEW TO DATE THEREFORE AN ANALYSIS OF THE PHYSICAL PRODUCT COULD NOT BE PERFORMED. ROOT CAUSE DESCRIPTION: THE PROBABLE ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO A BAD IMPRESSION TAKEN WHICH WOULD CAUSE THE DEVICE TO NOT FIT PROPERLY. 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 H5(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

    IT WAS REPORTED THAT A SILENT NITE 3D APPLIANCE HAS BROKEN. IT WAS REPORTED THAT THE CONNECTORS FRACTURED. THE PATIENT HAD THE DEVICE FOR ABOUT TWO MONTHS THEN THE APPLIANCE BROKE ON (B)(6) 2024. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575290 SILENT NITE 3D DEVICE, ANTI-SNORING LRK PRISMATIK DENTALCRAFT, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male