BEUDAMED
    FDA Adverse Event Other Summary report: N

    PURE SAPPHIRE BRACKETS

    MDR report key: 1586163 · Received January 22, 2010

    Report

    Report Number
    1056191-2010-00001
    Event Type
    Other
    Date Received
    January 22, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 22, 2010
    Manufacturer
    ORTHO TECHNOLOGY, INC.
    Product Code
    NJM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS BRAND OF BRACKET HAS SPECIFIC DE-BONDING INSTRUCTIONS; "DO NOT TWIST OR PULL THE BRACKET. REMOVE ALL FLASH FROM AROUND THE BRACKETS WITH A HIGH SPEED DE-BONDING BUR. GRASP THE BRACKET WITH A STRAIGHT OR ANGLED DE-BONDING PLIER AT THE BRACKET-ADHESIVE INTERFACE. GENTLY SQUEEZE THE PLIER AND GRADUALLY INCREASE PRESSURE UNTIL THE BRACKET COMES FREE FROM THE TOOTH." EVEN THOUGH OUR INVESTIGATION CONCLUDES OPERATOR ERROR, THE PT REQUIRED INTERVENTION TO REPAIR, THEREFORE, IT IS A REPORTABLE EVENT. WE ARE IMPROVING INSTRUCTIONS BY BOLDING "DO NOT TWIST OR PULL THE BRACKET" AND ENSURING THE INSTRUCTIONS ARE AVAILABLE ONLINE AND PROMINENTLY EVIDENT WITH EACH ORDER.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE REPORTED AN ISSUE WITH DE-BONDING AESTHETIC BRACKETS. DURING DE-BONDING, THE DOCTOR USED A DE-BONDING PLIER SECURED THE BRACKET DISTAL/MESIAL AND SLOWLY SQUEEZED THE INSTRUMENT, THE BRACKET FRACTURED AND CAME AWAY FROM THE TOOTH, WITH THE ADHESIVE IN PLACE AND TOOTH ENAMEL ATTACHED. THIS OCCURRED ON THE UPPER LEFT 5 (2ND BICUSPID). THE DOCTOR REFERRED THE PT TO A GENERAL DENTIST TO HAVE THE ENAMEL REPAIRED, WHICH MAKES THIS A REPORTABLE EVENT. AFTER DISCUSSION WITH THE DOCTOR, IT WAS DETERMINED THE DOCTOR DID NOT USE A BURR TO REMOVE THE FLASH. DOCTOR STATED THAT THE ADHESIVE HE USED IS PINK WHEN APPLIED AND HE REMOVES ALL FLASH DURING THE BONDING PROCESS. HOWEVER, OUR INSTRUCTIONS READ YOU MUST REMOVE ALL ADHESIVE AROUND THE BRACKET "FLASH" PRIOR TO DE-BONDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURE SAPPHIRE BRACKETS NJM - CERAMIC ORTHODONTIC BRACKETS NJM ORTHO TECHNOLOGY, INC. PURE BRAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention