BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE

    MDR report key: 382559 · Received March 15, 2002

    Report

    Report Number
    2016150-2002-00001
    Event Type
    Injury
    Date Received
    March 15, 2002
    Date of Event
    February 26, 2002
    Report Date
    February 26, 2002
    Manufacturer
    ORMCO CORP.
    Product Code
    DYW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ORTHODONTIST STATED THAT WHILE DEBONDING THE INSPIRE BRACKET WITH DEBONDING PLIERS, THE FACIAL CUSP OF THE UPPER RIGHT 1ST BICUSPID BROKE AWAY FROM THE REST OF THE TOOTH. THE ORTHODONTIST GRINDED THE REST OF THE BRACKETS OFF THE REMAINING TEETH. THE ORTHODONTIST IMMEDIATELY REFERRED THE PATIENT TO THEIR GENERAL DENTIST WHO APPLIED A PORCELAIN CROWN TO THE DAMAGED TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSPIRE ORTHODONTIC BRACKET DYW ORMCO CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention