BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERBST

    MDR report key: 1676036 · Received May 6, 2010

    Report

    Report Number
    2184045-2010-00003
    Event Type
    Injury
    Date Received
    May 6, 2010
    Report Date
    April 7, 2010
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    EJF
    PMA / PMN Number
    K923405
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON EVALUATION OF THE RETURNED APPLIANCE, IT WAS CONFIRMED THAT THE CROWN WAS LARGE IN RELATION TO THE NEW MODEL THAT WAS RETURNED WITH THE DEVICE; HOWEVER IT CANNOT BE DISCERNED WHETHER THE CROWN WAS LARGE IN RELATION TO THE ORIGINAL MODEL THAT WAS PROVIDED BECAUSE THE ORIGINAL MODEL IS NO LONGER AVAILABLE. ADJUSTMENTS TO THE CROWN IS INDETERMINABLE. IT APPEARS THAT THE DOCTOR BROKE THE TIP OF A TOOTH CUSP WHILE REMOVING THE CROWN. THE DOCTOR CONFIRMED THAT THE PATIENT IS DOING FINE AND THAT THE TOOTH WAS REPAIRED BY HIS DENTIST. THE DOCTOR STATED THAT THE PATIENT MAY HAVE AN ENAMEL DEFECT WHICH WOULD HAVE LED TO THE INCIDENT. A NEW SMALLER SIZED CROWN WAS MADE AND HAS BEEN SENT TO THE DOCTOR TO REPLACE THE LARGER CROWN.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A DOCTOR REPORTED THAT HE BROKE A PATIENT'S TOOTH WHILE REMOVING A HERBST APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERBST BITE-JUMPING ORTHODONTIC APPLIANCE EJF ALLESEE ORTHODONTIC APPLIANCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other