BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMILE

    MDR report key: 3182475 · Received June 21, 2013

    Report

    Report Number
    2024312-2013-00300
    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 REPLACED THE RESTORATION FOR THE PATIENT USING THE SAME PRODUCT, WITHOUT FURTHER INCIDENT. 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 THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283219 SIMILE DENTAL COMPOSITE EBF PENTRON CLINICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R