BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTAPER UNIVERSAL ROTARY FILE

    MDR report key: 3131302 · Received May 15, 2013

    Report

    Report Number
    8031010-2013-00004
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKS
    PMA / PMN Number
    K954790
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE INJURY OR ILLNESS THAT WOULD NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. TYPICALLY ROTARY NITI FILE SEPARATIONS THAT RESULT IN INJURY ARE REPORTED VIA ASR (B)(4). HOWEVER, DUE TO THE UNUSUAL CIRCUMSTANCES OF THIS EVENT, IT IS BEING REPORTED AS AN INDIVIDUAL MDR. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT THE DENTIST REPORTED THAT A PROTAPER UNIVERSAL ROTARY NITI FILE SEPARATED DURING TREATMENT AND COULD NOT BE RETRIEVED FROM THE PT'S ROOT CANAL. THE PT HAS ALLERGIES TO BOTH NICKEL AND COPPER. THE PT AGREED WITH THE DENTIST TO EVENTUALLY HAVE AN APEX RESECTION IN CASE THE ROOT CANAL WOULD GET INFECTED IN THE FUTURE AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216143 PROTAPER UNIVERSAL ROTARY FILE EKS DENTSPLY MAILLEFER

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention