BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLI5

    MDR report key: 2219016 · Received August 22, 2011

    Report

    Report Number
    2184045-2011-00008
    Event Type
    Injury
    Date Received
    August 22, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    NXC
    PMA / PMN Number
    K040874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT A PATIENT'S TOOTH CHIPPED WHILE WEARING THE ALIGNER APPLIANCE; HOWEVER, ON CONTACTING THE DOCTOR IT WAS CONFIRMED THAT SHE WAS NOT SURE IF THE ALIGNER APPLIANCE CAUSED THE INCIDENT. THE DOCTOR CONFIRMED THAT THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A DOCTOR REPORTED THAT A PATIENT'S TOOTH CHIPPED WHILE USING SIMPLI5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLI5 POSITIONER, TOOTH, PREFORMED NXC ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R