BEUDAMED
    FDA Adverse Event Other Summary report: N

    PURE SAPPHIRE BRACKETS

    MDR report key: 1414777 · Received July 13, 2009

    Report

    Report Number
    1056191-2009-00001
    Event Type
    Other
    Date Received
    July 13, 2009
    Date of Event
    May 12, 2009
    Report Date
    July 6, 2009
    Manufacturer
    ORTHO TECHNOLOGY, INC.
    Product Code
    NJM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE REPORTED AN ISSUE WITH DE-BONDING AESTHETIC BRACKETS. THE REPORTER STATED THIS WAS THE FIRST TIME THE DOCTOR HAD RE-BONDED THIS BRAND OF BRACKETS, SO HE HAD THE INSTRUCTIONS OUT FOR REFERENCE. UPON DE-BONDING, THE DOCTOR REALIZED THE ADHESIVE REMAINED ON THE BRACKET AND ALSO FRACTURED A PORTION OF THE PT'S ENAMEL ON A LOWER BICUSPID. AS STANDARD PRACTICE, THE DOCTOR REMOVES ALL FLASH BEFORE CURING THE ADHESIVE, THEREFORE, THERE WAS NO VISIBLE ADHESIVE TO BE REMOVED BEFORE DE-BONDING (PER OUR INSTRUCTIONS). THE REPORTER STATED THE DOCTOR GENERALLY FLEXES FROM SIDE TO SIDE, BUT HAD TO FLEX VERTICALLY TO GET THE BRACKET TO COME OFF IN THIS INSTANCE. THE DOCTOR DID NOT FOLLOW DE-BONDING DIRECTIONS, SINCE THEY STATE DO NOT TWIST OR PULL THE BRACKET. IN ADDITION, THE DOCTOR CLAIMS TO HAVE USED OUR ANGLED DE-BONDING PLIER, HOWEVER, WE SHOW NO RECORD OF PURCHASE OF THIS PLIER OR ANY OTHER DE-BONDING PLIERS. THE DOCTOR IS AWARE OF THE INHERENT ISSUES WITH DE-BONDING AESTHETIC BRACKETS, AND MAKES ALL PTS SIGN A WAIVER. PER THE REPORTER, THIS PARTICULAR PT ALREADY HAD RESTORATIVE WORK SCHEDULED AND HAD THIS REPAIR INCLUDED BY HER GENERAL DENTIST. THE BRACKET WAS NOT RETURNED FOR EVAL OR TO DETERMINE IF IT WAS INDEED OUR BRAND OF BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURE SAPPHIRE BRACKETS NJM - CERAMIC ORTHODONTIC BRACKETS NJM ORTHO TECHNOLOGY, INC. S22931 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention