BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON DEBONDING PLIERS

    MDR report key: 1398205 · Received June 4, 2009

    Report

    Report Number
    2016150-2009-00036
    Event Type
    Injury
    Date Received
    June 4, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 6, 2009
    Manufacturer
    ORMCO CORPORATION
    Product Code
    JEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REPORTED THAT THE PATIENT WAS SENT TO HIS DENTIST IMMEDIATELY AFTER THE INCIDENT TO HAVE THE FRACTURED TOOTH EXAMINED. THE PATIENT'S DENTIST REMOVED THE FRACTURED TOOTH PORTION, PERFORMED A ROOT CANAL AND PLACED A TEMPORARY CROWN. THE PATIENT IS CURRENTLY DOING WELL AND WAITING FOR THE PLACEMENT OF A PERMANENT CROWN. THE DOCTOR REPORTED THAT AN EVALUATION OF THE PATIENT'S X-RAYS INDICATED THAT THERE WAS NO DAMAGE TO THE PATIENT'S TOOTH STRUCTURE PRIOR TO ORTHODONTIC TREATMENT. THE DOCTOR HAS MADE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL PATIENT DENTAL HISTORY INFORMATION FROM THE PATIENT'S DENTIST; HOWEVER, THE PATIENT'S DENTIST HAS REMAINED UNRESPONSIVE. THE PRODUCT WAS RETURNED TO ORMCO CORPORATION FOR EVALUATION. THE EVALUATION WAS UNABLE TO DETERMINE THE CAUSE OF THE TIP BREAKAGE. THE RESULTS OF MATERIAL HARDNESS TESTING INDICATED THAT THE TIP WAS WITHIN PRODUCT SPECIFICATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT REVEALED RUST ON THE TIP AND TWO PITS WHICH INDICATE WHERE THE FRACTURE ORIGINATED. IT CANNOT BE OPTICALLY DETERMINED HOWEVER, IF THESE PITS EXISTED PRIOR TO THE BREAKAGE OR IF THEY OCCURRED AS A RESULT OF THE BREAKAGE.THIS IS THE FINAL REPORT. - ATTACHMENT: [DAMONDEBONDINGPLIER 2016150-2009-00036 - EVALUATION.PDF]

    Description of Event or Problem · 1

    IN 2009, ORMCO CORPORATION RECEIVED NOTIFICATION THAT DURING THE DEBONDING OF BRACKETS, THE TIP OF THE DAMON DEBONDING PLIER BROKE AND FRACTURED THE CROWN PORTION OF A PATIENT'S TOOTH #41.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAMON DEBONDING PLIERS ORTHODONTIC PLIER JEX ORMCO CORPORATION 07F51F

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other| R