BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBSIDIAN BLOCK A2 MILLING BLOCKS

    MDR report key: 20582865 · Received October 31, 2024

    Report

    Report Number
    3011649314-2024-00848
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    March 16, 2023
    Report Date
    December 30, 2024
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    EIH
    PMA / PMN Number
    K141887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE SKU/CATALOG NUMBER NOR THE LOT NUMBER OF THE DEVICE WAS AVAILABLE FOR THE REPORTED COMPLAINT. THE CUSTOMER REPORTED THAT THIS INFORMATION IS NOT KNOWN AND THAT THE PATIENT KEPT THE DEVICE AND "AFTER SO MUCH TIME PASSED, I DO NOT THINK THE PATIENT'S KEPT THEM". THEREFORE, A REVIEW OF THE DEVICE LOT HISTORY RECORDS COULD NOT BE CONDUCTED AT THIS TIME. IMAGES OF THE DEVICE WERE PROVIDED AND WILL BE REVIEWED. AT THE COMPLETION OF OUR INVESTIGATION, A FINAL REPORT WILL BE PROVIDED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). THIS IS THE FIRST OF THREE COMPLAINTS FOR THE SAME PATIENT, RELATED MDR NUMBERS: 3011649314-2024-00846. 3011649314-2024-00847.

    Additional Manufacturer Narrative · 0

    A NON-VISUAL DEVICE EVALUATION HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: DHR RESULTS: THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE DHR COULD NOT BE REVIEWED. STOCK PRODUCT REVIEWED RESULTS: THE LOT NUMBER WAS NOT PROVIDED THEREFORE THE STOCK PRODUCT COULD NOT BE REVIEWED. INVESTIGATION METHODS/RESULTS: PER THE REPORTED INFORMATION, THE DEVICE WILL NOT BE RETURNED, AND PICTURES WERE NOT PROVIDED. ROOT CAUSE THE ROOT CAUSE CANNOT BE EXPLICITLY DETERMINED. THE PROBABLE ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO HOW THE PATIENT USED THE RESTORATION SUCH AS POTENTIALLY BITING DOWN A HARD OBJECT WHICH CAN CAUSE A RESTORATION TO FRACTURE. IT IS UNKNOWN THE PATIENT'S MEDICAL HISTORY, BUT BRUXISM CAN ALSO CAUSE THE RESTORATION FRACTURE OVER TIME DUE TO THE EXCESSIVE PRESSURE AND GRINDING ON THE RESTORATION WHICH CAN LEAD TO THE DECREASE IN STRENGTH OF THE RESTORATION. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: COMP-(B)(4).

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). THIS IS THE THIRD OF THREE COMPLAINTS RELATED TO MDR NUMBERS: 3011649314-2024-00846; 3011649314-2024-00847.

    Description of Event or Problem · 0

    OFFICE REPORTED CROWN CRACKED IN THE PATIENT'S MOUTH FOR TOOTH #21. THE DOCTOR IS STATED THAT THIS IS THE THIRD TIME THEY HAVE HAD THIS HAPPEN WITH OBSIDIAN CROWNS AND IS LOOSING CONFIDENCE WITH THE MATERIAL. THE OFFICE STATED THEY USE THE OVEN AND SETTINGS PROVIDED BY GLIDEWELL. NO OTHER INFORMATION WAS PROVIDED AND NO ADVERSE CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961837 OBSIDIAN BLOCK A2 MILLING BLOCKS OBSIDIAN PRESS (ALL CERAMIC AND PRESS) EIH PRISMATIK DENTALCRAFT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown