BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISTE NANO COMPOSITE

    MDR report key: 2398040 · Received January 4, 2012

    Report

    Report Number
    2024312-2012-00003
    Event Type
    Injury
    Date Received
    January 4, 2012
    Report Date
    December 6, 2011
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K020555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE DURATION OF TIME FROM THE INITIAL PROCEDURE TO THE TIME THE RESTORATION HAD TO BE REDONE. HE ALSO DID NOT MENTION WHICH COMPOSITE WAS USED TO REDO THE RESTORATIONS. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED; THEREFORE, AN EVALUATION WAS PERFORMED ON THE RETAIN SAMPLE YIELDING RESULTS WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION OF THE RETURNED PRODUCT WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE DOCTOR STATED THAT HE HAD TO REDO THE RESTORATIONS ON THREE TO FIVE PATIENTS BECAUSE THERE WERE ALLEGED BLACK SPOTS UNDERNEATH THE RESTORATIONS. THE CUSTOMER STATED THAT HE DID NOT SEE THESE SPOTS AT THE TIME OF THE INITIAL PROCEDURE. THIS IS THE THIRD OF FIVE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTISTE NANO COMPOSITE MATERIAL, TOOTH SHADE, RESIN EBF PENTRON CLINICAL 169682

    Patients

    Seq Age Sex Outcome Treatment
    1 Other