BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBSIDIAN MILLING BLOCK

    MDR report key: 11127913 · Received January 6, 2021

    Report

    Report Number
    3011649314-2017-00549
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    April 20, 2017
    Report Date
    January 6, 2021
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    EIH
    PMA / PMN Number
    K141788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BEEN RETURNED. HOWEVER, THERE WILL BE A NON-VISUAL INVESTIGATION CARRIED OUT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE HISTORY RECORD: NOT ABLE TO REVIEW THE DEVICE HISTORY RECORD. PRODUCT, SKU AND LOT/SERIAL NUMBERS WERE NOT PROVIDED. STOCK PRODUCT REVIEWED: NOT ABLE TO REVIEW STOCK PRODUCTS. PRODUCT, SKU AND LOT/SERIAL NUMBERS WERE NOT PROVIDED. RETURNED SAMPLE: DEVICE NOT RETURNED FOR EVALUATION. ROOT CAUSE: ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE CROWNS WERE FABRICATED AT CHAIRSIDE. ALL THE FRACTURES OCCURRED AFTER THE CEMENTATION UPON PATIENT RETURN CHECK-UP. UNABLE TO DETERMINE THE MILLING MACHINE USED BY THE CUSTOMER. NO DEATH, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED FROM THE PATIENT. THE POSSIBLE ROOT CAUSE COULD BE RELATED TO THE OPERATOR'S TECHNIQUE, BUT WITHOUT FURTHER INFORMATION WE CANNOT DETERMINE THE EXACT DETAILED ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE OBSIDIAN CROWN CRACKED ON TOOTH #14. THE CROWN IS STILL IN PLACE. THE OFFICE REPORTS THAT THERE IS NO ISSUE WHEN THE CROWNS ARE BEING MILLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21726 OBSIDIAN MILLING BLOCK OBSIDIAN MILLING BLOCK EIH PRISMATIK DENTALCRAFT, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR