BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI-TI WIRE

    MDR report key: 4853075 · Received June 18, 2015

    Report

    Report Number
    2016150-2015-00017
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 28, 2015
    Manufacturer
    ORMCO CORPORATION
    Product Code
    ECN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT CATALOG NUMBERS ASSOCIATED WITH THE BREAKAGE OF THE WIRE, HE COULD NOT VERIFY WHICH CATALOG NUMBER HAD BROKEN; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED. THE CATALOG NUMBERS INVOLVED IN THE ALLEGED INCIDENT INCLUDED CATALOG NUMBERS 205-0004, 205-0008. THE PATIENT SOUGHT FURTHER MEDICAL ATTENTION AT THE EMERGENCY ROOM. AN X-RAY WAS TAKEN AND SURGERY WAS PERFORMED TO REMOVE THE BROKEN PART. IT WAS REPORTED THAT THE DOCTOR BELIEVES THAT THE ARCHWIRE HAD BEEN BROKEN THROUGH DELIBERATE AND CARELESS ACTION BY THE PATIENT. NO FURTHER PATIENT HEALTH STATUS INFORMATION WAS REPORTED. AN UPDATE WILL BE PROVIDED IF ANY FURTHER INFORMATION IS OBTAINED. THE PRODUCT INVOLVED IN THIS INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE NITI ARCHWIRE HAD BROKEN IN A PATIENT'S MOUTH AND THE PATIENT HAD SWALLOWED THE BROKEN PART DURING DAILY ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398520 NI-TI WIRE WIRE, ORTHODONTIC ECN ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R