BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADHESIVES

    MDR report key: 2823485 · Received November 2, 2012

    Report

    Report Number
    1718912-2012-00006
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 2, 2012
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Product Code
    DYH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR (B)(6) STATED THAT THEY HAVE HAD 3 SIGNIFICANT ENAMEL FRACTURES IN THE LAST 2 WEEKS AND THEY WERE ALL PTS WITH OPAL SEAL. THIS IS THE ONLY PRODUCT THEY HAVE CHANGED IN THEIR BONDING PROTOCOL OVER THE LAST FEW YRS AND ARE VERY CONCERNED. TWO PTS WERE WEARING CLARITY (CERAMIC) AND 1 VICTORY (METAL) SERIES. (COMPETITOR BRACKETS). NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADHESIVES BRACKET ADHESIVES RESIN DYH ULTRADENT PRODUCTS, INC. 500-062

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability