BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCON BASE DISK WHITE 20 MM

    MDR report key: 6049469 · Received October 21, 2016

    Report

    Report Number
    2647456-2016-00001
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 22, 2016
    Manufacturer
    DENTSPLY PROSTHETICS
    Product Code
    EIH
    PMA / PMN Number
    K051462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED BRIDGE WAS IN THE MOUTH FOR OVER 9 MONTHS AND DID NOT HAVE A LOT NUMBER ASSOCIATED TO INVESTIGATE FURTHER. ZIRCONIA IS NOT LIKELY TO CAUSE AN ALLERGIC REACTION, THE CUSTOMER WILL ALSO BE INFORMED TO RELAY TO THE CLINICIAN THAT THE PATIENT SHOULD UNDERGO ALLERGY TESTING AND ALSO LOOK TO POSSIBLE CAUSES RELATING TO CEMENT USED AS WELL AS STAIN AND GLAZE APPLIED TO THE BRIDGE BY THE DENTAL LAB.

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    A DENTAL LAB REPORTED A POSSIBLE ALLERGIC REACTION A PATIENT WAS EXPERIENCING FROM A (B)(6) UNIT BRIDGE FASHIONED WITH CERCON BASE. THE PATIENT REPORTED EXPERIENCING A BURNING SENSATION ON THE TISSUE IN THE AREA OF THE BRIDGE. REMOVAL OF THE DEVICE ALLEVIATES THE PATIENT'S SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700551 CERCON BASE DISK WHITE 20 MM POWDER, PORCELAIN EIH DENTSPLY PROSTHETICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other