BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLI5

    MDR report key: 1666314 · Received April 25, 2010

    Report

    Report Number
    2184045-2010-00002
    Event Type
    Injury
    Date Received
    April 25, 2010
    Report Date
    March 24, 2010
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    NXC
    PMA / PMN Number
    K040874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE EACH APPLIANCE IS CUSTOM MADE TO THE REQUEST OF THE PRESCRIPTION THERE WAS NO PRODUCT PROBLEM. THE DOCTOR STATED THAT THE TOOTH HAD BEEN PREVIOUSLY FRACTURED AND REPAIRED AND THE PRESSURE OF THE APPLIANCE CAUSED IT TO FRACTURE AGAIN. THE DOCTOR CONFIRMED THAT THE PATIENT IS DOING FINE AND THAT THE TOOTH WAS REPAIRED. THE DOCTOR STATED THAT IT IS UNCERTAIN WHETHER OR NOT A NEW APPLIANCE WILL BE PLACED.

    Description of Event or Problem · 1

    ON MARCH 24, 2010, A DOCTOR REPORTED THAT A A SIMPLI5 APPLIANCE CAUSED A TOOTH FRACTURE.

    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