BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUFLEX NICKEL TITANIUM FULL FORM ARCHWIRES

    MDR report key: 1271503 · Received December 22, 2008

    Report

    Report Number
    1056191-2008-00001
    Event Type
    Other
    Date Received
    December 22, 2008
    Date of Event
    November 15, 2008
    Report Date
    December 18, 2008
    Manufacturer
    ORTHO TECHNOLOGY INC.
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A MFR NOTE, WE DO NOT HAVE ANY HISTORY OF WIRE BREAKAGE DURING USAGE. A FOLLOW UP QUESTIONNAIRE NOTED WHERE THE WIRE BROKE THERE WAS A SPACE BETWEEN THE TEETH, AND THE WIRE HAD BEEN IN PLACE FOR 14 DAYS. WE HAVE ATTEMPTED TO ASK FOR THE RESIDUAL WIRE BACK TO INSPECT FOR DEFECTS AND TO INVESTIGATE IF THE EVENT WAS DUE TO DOCTOR ERROR, PT MIS-USE OR MFR DEFECT. THE LOT NUMBER COULD NOT BE TRACKED AS THE OFFICE USES AN ARCHWIRE ORGANIZER FOR STORAGE AND THE PACKAGING IS DISPOSED. REQUESTS WERE ALSO MADE FOR PHOTOS OF THE RESIDUAL WIRES AND PHOTOS OF PT, HOWEVER, THESE REQUESTS WERE DECLINED. THEREFORE, WE CANNOT CONFIRM THE WIRE USED WAS OURS, BUT WE CONTINUE TO FOLLOW UP WITH THE DOCTOR REGARDING THE PT'S WELL-BEING AND ANY FURTHER INVESTIGATION THAT IS REQUIRED. WE FOLLOWED UP WITH THE DOCTOR ON (B) (6), 2008 AND HE CONFIRMED THE PT IS ABSOLUTELY FINE WITH NO PROBLEMS. THE DOCTOR IS PLEASED WITH THE RESOLUTION AND APPRECIATIVE OF THE CONSIDERATION GIVEN TO THIS MATTER.

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING ORTHODONTIC TREATMENT FOR CLASS III CASE WITH NITI WIRE, TOOTH BONDED TWIN/ROTH BRACKETS AND ELASTOMERIC LIGATURES. THE DOCTOR INFORMED US THE MOTHER OF THE PT CONTACTED HIM ON (B) (6) 2008, TO INFORM HIM THE PT SWALLOWED A PIECE OF NITI WIRE THAT BROKE LOOSE IN HIS MOUTH WHILE EATING. THE MOTHER STATED THE PT WAS TAKEN TO THE ER WHERE DOCTORS CONFIRMED VIA X-RAYS THAT HE DID SWALLOW A SMALL PORTION OF THE WIRE. THE MOTHER WAS CONCERNED THE PT COULD FACE FUTURE HEALTH PROBLEMS DUE TO THE INCIDENT. THE PT WAS TAKEN BACK TO THE DOCTOR'S OFFICE ON (B) (6) 2008, FOR IMMEDIATE DEBONDING PER THE MOTHER'S REQUEST. THE DOCTOR FOLLOWED UP WITH THE ER PHYSICIAN WHO EXAMINED THE PT IN QUESTION AND THE ER PHYSICIAN STATED :THE WIRE IS MOVING PERFECTLY AND SHOULD PASS AT ANY TIME. THE DOCTOR SAYS HE IS NOT CONCERNED WITH THE POSSIBILITY OF ANY FUTURE HEALTH ISSUES AFTER SPEAKING WITH THE ER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUFLEX NICKEL TITANIUM FULL FORM ARCHWIRES ORTHODONTIC NICKEL TITANIUM ARCHWIRES DZC ORTHO TECHNOLOGY INC. 6000-203 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other TWIN/ROTH RX BRACKETS| ELASTOMETRIC LIGATURES