BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDSNORZ SLEEP APPLIANCE

    MDR report key: 18818202 · Received March 1, 2024

    Report

    Report Number
    3011649314-2024-00144
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    January 5, 2024
    Report Date
    October 12, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    LRK
    PMA / PMN Number
    K211069
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE EXACT CAUSE OF THE EVENT IS UNKNOWN AND CURRENTLY UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED, THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS. THE DEVICE WAS MANUFACTURED AT THE NEW WEST LAB. THE CASE ORDER 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 WAS NOT RETURNED TO THE COMPLAINT HANDLING TEAM. HOWEVER, IT WAS REPORTED THAT A DEVICE WAS RETURNED AND INSPECTED BY W. FRIEBAUER (DIRECTOR - R&D). IT COULD NOT BE DETERMINED WHICH CUSTOMER THE DEVICE BELONGED TO. REFER TO THE ATTACHED EMAIL "FW ENDSNORZ PHOTOS" FOR THE INSPECTION RESULTS. ROOT CAUSE DESCRIPTION. REFER TO THE ATTACHED EMAIL "FW ENDSNORZ PHOTOS" FOR THE ROOT CAUSE. MANUFACTURER REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTED: G3, H6. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE BUMPS BROKE OFF THAT HOLDS THE ARMS ON THE ENDSNORZ APPLIANCE. THE DEVICE WAS DELIVERED AND FIRST USED BY THE PATIENT ON (B)(6) 2023. THE PATIENT FIRST EXPERIENCED THE ISSUE ON (B)(6) 2024 AND STOPPED USING THE DEVICE THAT DAY. THE DEVICE WAS CLEANED AND MAINTAINED WITH A TOOTHBRUSH AND SOFT SOAP. THE PATIENT IS CURRENTLY WEARING A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919878 ENDSNORZ SLEEP APPLIANCE ANTI SNORING NIGHTGAURD LRK PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Unknown