BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRUXZIR ESTHETIC NOW SHADE A1

    MDR report key: 20664756 · Received November 12, 2024

    Report

    Report Number
    3011649314-2024-00880
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    November 4, 2024
    Report Date
    October 19, 2025
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    EIH
    PMA / PMN Number
    K213425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: NO LOT NUMBER PROVIDED, THEREFORE NO DHR REVIEW WAS PERFORMED. STOCK PRODUCT REVIEWED RESULTS: NO LOT NUMBER PROVIDED; THEREFORE, NO STOCK PRODUCT REVIEW WAS PERFORMED. INVESTIGATION METHODS/RESULTS: PER THE REPORTED INFORMATION, THE PRODUCT WAS DISCARDED BY THE CUSTOMER. HOWEVER, PICTURES WERE PROVIDED. THE PICTURES WERE REVIEWED AND IT APPEARED THAT THE RESTORATION WAS CHIPPED ON THE SIDE WHERE A PIECE OF THE RESTORATION IS MISSING. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE FOR THIS FAILURE CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE CAUSE FOR THE FRACTURED/CRACKING ISSUE MAY BE THE AS FOLLOWS: IFU-012545 - FAILURE TO OBSERVE THE WALL AND CONNECTOR THICKNESS RECOMMENDATIONS AS SHOWN IN TABLE 2 MAY RESULT IN FRACTURE OF THE FINAL RESTORATION. HOWEVER, THE ROOT CAUSE CANNOT BE CONFIRMED SINCE THE BLOCK WAS NOT RETURNED FOR INVESTIGATION. MANUFACTURER REFERENCE: (B)(4).

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT A CROWN WAS CEMENTED ON (B)(6) 2023. THE PATIENT REPORTED ON (B)(6) 2024 THAT WHILE EATING BIT ON THE CROWN AND BROKE. THE PROVIDER HAD TO RE-PREP AND MILL OUT A NEW CROWN FOR THE PATIENT AND REPLACED CROWN ON (B)(6) 2024. NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136024 BRUXZIR ESTHETIC NOW SHADE A1 BRUXZIR ESTHETIC EIH PRISMATIK DENTALCRAFT, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male