BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D3MX DEBONDING PLIER

    MDR report key: 1691748 · Received May 17, 2010

    Report

    Report Number
    2016150-2010-00062
    Event Type
    Injury
    Date Received
    May 17, 2010
    Report Date
    December 17, 2009
    Manufacturer
    ORMCO CORPORATION
    Product Code
    JEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO CONTACT (B) (6) VIA PHONE ON MAY 5, 2010, AND MAY 6, 2010 AND VIA EMAIL ON MAY 4, 2010 IN ORDER TO OBTAIN ADDITIONAL INFORMATION ON THIS INCIDENT; HOWEVER NO RESPONSE WAS RECEIVED. THE DEVICE WAS NOT RETURNED TO ORMCO FOR EVALUATION. DUE TO LACK OF INFORMATION, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B) (6), 2009 A DOCTOR REPORTED TO ORMCO CORPORATION THAT A D3MX DEBONDER SCRAPED THE ENAMEL OFF A PATIENT'S TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D3MX DEBONDING PLIER DENTAL HAND INSTRUMENT JEX ORMCO CORPORATION 11073850B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other