BEUDAMED
    FDA Adverse Event Other Summary report: N

    CENTRIX - VERSA FLOW A2

    MDR report key: 222206 · Received April 28, 1999

    Report

    Report Number
    MW1016261
    Event Type
    Other
    Date Received
    April 28, 1999
    Date of Event
    September 23, 1998
    Report Date
    April 27, 1999
    Manufacturer
    CENTRIX, INC.
    Product Code
    EBF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON 9/23/99, A SMALL SEALANT ON TOOTH #3 WAS REPLACED WITH VERSA FLOW (A CENTRIX PRODUCT), BONDED WITH OPTIBOND (A KERR PRODUCT). THE PREPARATION WAS VERY SMALL AND SHALLOW. THE TOOTH BECAME SENSITIVE RIGHT AWAY, AND RATHER THAN IMPROVING, BECAME WORSE WITH TIME. RPTR HAS SEEN THIS PATTERN BEFORE WITH THIS PRODUCT. RPTR REPLACED THE RESTORATION WITH ONE OF PRISMA TPH AND JENERIC PENTRON BOND 1, WHICH HAD HELPED OTHER PT'S TEETH THAT WERE SENSITIVE TO VERSA FLOW RESTORATIONS. THIS WAS ON 12/11/98. THIS HAD NO EFFECT. ON 3/1/99, RPTR REFERRED PT TO ANOTHER DR, WHO SAID THAT ALTHOUGH THE RESTORATION WAS SMALL AND SHALLOW, THE PULP WAS HYPEREMIC AND MAY HAVE DEGENERATIVE CHANGES. ON 3/17/99, DISCOMFORT HAD INCREASED AND #3 RECEIVED ROOT CANAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRIX - VERSA FLOW A2 Implant FLOWABLE COMPOSITE EBF CENTRIX, INC. SHADE A1 25517

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other ULTRADENT. ON 12/11/99 - BOND 1 BY JENERIC PENTRON| PPHA2 BY PRISMA, ULTRAETCH BY ULTRADENT.| ON 9/23/98 - OPTIBOND BY KERR, ULTRAETCH BY