BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCCLUS KISS

    MDR report key: 3800240 · Received April 30, 2014

    Report

    Report Number
    9681199-2014-00001
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    March 31, 2014
    Manufacturer
    DEGUDENT GMBH
    Product Code
    EJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, ITIS 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 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE WHEN TAKING INTO ACCOUNT COMPOSITION AND INDICATIONS FOR USE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT THREE DAYS AFTER INSERTING AN IMPLANT-SUPPORTED BRIDGE MADE WITH BIOCCLUS KISS AND DUCERAM KISS, A PATIENT REPORTED THEY HAD A SWELLING AND A METALLIC TASTE IN THEIR MOUTH. THE BRIDGE WAS IMMEDIATELY REMOVED. THE CUSTOMER STATED THAT THE BRIDGE WAS NOT GLAZE-BURNED, BUT POLISHED WITH A DIAMOND PASTE AND HAS NOT EVAPORATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258671 BIOCCLUS KISS ALLOY, GOLD-BASED NOBLE METAL EJT DEGUDENT GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DUCERAM KISS