BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCH BENDING PLIER

    MDR report key: 822758 · Received March 1, 2007

    Report

    Report Number
    2016150-2007-00008
    Event Type
    Injury
    Date Received
    March 1, 2007
    Date of Event
    November 1, 2006
    Report Date
    January 31, 2007
    Manufacturer
    ORMCO CORP.
    Product Code
    JEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR RE-ATTACHED THE CHIPPED PORTIONS TO THE PATIENT'S TEETH USING A DENTAL ADHESIVE. THE SUSPECT DEVICE WAS OVER 10 YEARS OLD - WHICH IS 5 YEARS BEYOND THE STATED USE-LIFE OF THE PRODUCT.

    Description of Event or Problem · 1

    IN JANUARY 2007 AN ATTORNEY INFORMED ORMCO CORPORATION THAT AN ARCH BENDING PLIER BROKE DURING AN ORTHODONTIC ADJUSTMENT PERFORMED BY HIS CLIENT/DOCTOR, CAUSING THE DOCTOR TO CHIP TWO OF THE PATIENT'S TEETH (#'S 9 & 10).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCH BENDING PLIER ORTHODONTIC PLIER JEX ORMCO CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention| S