BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    78 ROOT TIP ELEV

    MDR report key: 2572417 · Received May 8, 2012

    Report

    Report Number
    2523190-2012-00044
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Report Date
    May 8, 2012
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    BROKEN TIPS, PT SWALLOWED TIP. DOCTOR REPORTED VIA PHONE THAT HE WAS PERFORMING A DIFFICULT AND COMPLEX EXTRACTION WHEN THE CROWN OF THE TOOTH CAME OFF. HE WAS USING THE ROOT TIP ELEVATOR TO PRY THE ROOTS OUT WITH THE EXCESSIVE EXCESS FORCE NEEDED WHEN THE TIP BROKE OFF. PT SWALLOWED TIP, SHE WAS REFERRED TO HER GENERAL PRACTITIONER, AN X-RAY WAS TAKEN AND THE FILM SHOWED NO TIP. IT IS PRESUMED THAT SHE PASSED IT NATURALLY. NO PT CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 78 ROOT TIP ELEV M51 - GENERAL DENTISTRY EMJ INTEGRA YORK, PA INC

    Patients

    Seq Age Sex Outcome Treatment
    1