BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILE

    MDR report key: 3182470 · Received June 21, 2013

    Report

    Report Number
    2024312-2013-00299
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 6, 2013
    Manufacturer
    PENTRON CLINICAL
    Product Code
    EBF
    PMA / PMN Number
    K052106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD EXPERIENCED A DEBONDING OF RESTORATION AFTER ONE (1) MONTH OF PLACEMENT; THE DOCTOR WILL RE-DO THE RESTORATION FOR THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT RESTORATIONS HAD DEBONDED AFTER PLACEMENT WITH THE SIMILE COMPOSITE. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283663 SIMILE DENTAL COMPOSITE EBF PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R