BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILE

    MDR report key: 1831580 · Received September 11, 2010

    Report

    Report Number
    2024312-2010-00082
    Event Type
    Injury
    Date Received
    September 11, 2010
    Report Date
    August 10, 2010
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K052106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT RESTORATIONS THAT HAD BEEN PLACED WITH SIMILE DENTAL COMPOSITE HAD TO BE REDONE. THE DOCTOR STATED THE PATIENT'S BRUXISM MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DOCTOR IDENTIFIED TWO DIFFERENT SHADES OF SIMILE. HE DID NOT, HOWEVER, SPECIFY WHICH SHADE WAS USED ON THE PATIENT. IN ADDITION, THE DOCTOR DID NOT RETURN THE PRODUCTS; THEREFORE RETAIN SAMPLES WERE EVALUATED FOR BARCOL HARDNESS. BECAUSE BOTH SAMPLES MEET PRODUCT SPECIFICATIONS, IT HAS BEEN CONCLUDED THAT THIS INCIDENT OCCURRED AS A RESULT OF A USER OR TECHNIQUE-RELATED PROBLEM. BECAUSE THERE HAVE BEEN NO OTHER INCIDENTS OR COMPLAINTS OF THIS NATURE ASSOCIATED WITH THESE PRODUCT LOTS, THIS INCIDENT APPEARS TO BE AN ISOLATED INCIDENT. (B)(4). A RETAIN SAMPLE WAS EVALUATED.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED THAT RESTORATIONS THAT HAD BEEN PLACED WITH SIMILE DENTAL COMPOSITE HAD TO BE REDONE. THIS IS THE THIRD OF FIVE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMILE DENTAL COMPOSITE EBF PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other