BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 371072 · Received January 8, 2002

    Report

    Report Number
    2016150-2001-00001
    Event Type
    Injury
    Date Received
    January 8, 2002
    Date of Event
    December 7, 2001
    Report Date
    December 7, 2001
    Manufacturer
    ORMCO CORPORATION
    Product Code
    EJF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WHO INITIALLY PLACED THE APPLIANCE ON THE PATIENT'S TOOTH REPORTED THAT THE PATIENT CAME INTO THE OFFICE WITH A BRACKET THAT WAS ACCIDENTLY DEBONDED. THE PATIENT EXPERIENCED ENAMEL DAMAGE AT THE SITE OF DEBONDING IN THE FORM OF A VERY NARROW FISSURE, APPROXIMATELY 4MM IN LENGTH, STARTING AT THE "CEJ", WHERE THE TOOTH MEETS THE ROOT NEAR THE GINGIVAL, AND RADIATING TOWARDS BUT NOT REACHING THE OCCLUSSAL EDGE. THE TOOTH WAS RESTORED WITH A COMPOSITE MATERIAL AND ANOTHER BRACKET WAS PUT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRE ORTHODONTIC BRACKET EJF ORMCO CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention APPLICATION UNK.| RELIANCE LIGHT BOND (MANUFACTURER UNK), DATE OF