BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAESTRO MINI-TWIN BRACKET WITH HOOK

    MDR report key: 4068001 · Received August 12, 2014

    Report

    Report Number
    2081322-2014-00001
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 15, 2014
    Report Date
    August 12, 2014
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TOOTH FRACTURE CAN OCCUR UPON DEBONDING (REMOVAL) OF BRACKET. ALTHOUGH MOST FRACTURES ARE LIMITED TO ENAMEL, THE POTENTIAL FOR PULPAL INVOLVEMENT EXISTS. LITERATURE DESCRIBING DEBONDING ADVERSE EVENTS CAN BE TRACKED BACK TO AT LEAST 1996. PROVIDERS ARE TRAINED TO USE CARE WHEN DEBONDING BRACKETS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, BRACKETS WERE PLACED. INITIAL DIAGNOSIS: CLASS I 18 MONTHS, MODERATE CROWDING. TOOTH #11 PERFECTLY HEALTHY WITH NO SIGNS OF PREVIOUS RESTORATIONS, DECAY, OR DECALCIFICATION. DENTIST WAS REMOVING BRACKET FROM UL3 (TOOTH #11) AND TOOTH BROKE HORIZONTALLY IN HALF. POST INCIDENT DIAGNOSIS: #11 HORIZONTAL FRACTURE WITH SMALL PULPAL INVOLVEMENT. NO SIGNS OF DECALCIFICATION OR DECAY. CLEAN FRACTURE WITH BRACKET STILL ATTACHED TO THE FRACTURED PORTION. 2 LUGS BROKEN DURING REMOVAL. TOOTH #11 WILL NEED ENDO WITH BUILD UP AND EMAX CROWN AT A LATER DATE. TOOTH WAS BONDED BACK TOGETHER AND NEW BRACKET PLACED ON TOOTH. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479095 MAESTRO MINI-TWIN BRACKET WITH HOOK EJF ORTHO ORGANIZERS, INC. 711-399 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention TRIUMPH BRACKET REMOVER, PN 205-220XL, PLIERS| TRANSBOND XT, PN 133-0606, BRACKET ADHESIVE