BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NICKEL TITANIUM FILE - NAME UNK

    MDR report key: 710055 · Received May 9, 2006

    Report

    Report Number
    3019316-2006-00001
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    February 2, 2005
    Report Date
    April 25, 2006
    Manufacturer
    SYBRON ENDO, A DIV. OF SYBRON DENTAL SPECIALTIES
    Product Code
    EKS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON FEBRAURY 2, 2005 A PT ALLEGED THAT DURING A ROOT CANAL TREATMENT A FILE BROKE IN THE PT'S TOOTH, #12. THE PT WAS REFERRED TO AN ENDODONTIST WHO ATTEMPTED TO REMOVED THE FILE, BUT WAS UNSUCCESSFUL. ACCORDING TO THE PT, THE FILE BROKE SEVERAL TIMES DURING THE PROCESS SO SHE AVISED TO EXTRACT THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NICKEL TITANIUM FILE - NAME UNK FILE, PULP CANAL, ENDODONTIC EKS SYBRON ENDO, A DIV. OF SYBRON DENTAL SPECIALTIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other