BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER UNIVERSAL 21MM-F2

    MDR report key: 9573189 · Received January 9, 2020

    Report

    Report Number
    8031010-2019-00302
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Report Date
    September 11, 2020
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. THE PROVIDED BATCH NUMBER (BATCH #070178) HAS NO CORRESPONDING IN OUR SYSTEM. THE RIGHT BATCH NUMBER IS UNKNOWN, DHR CANNOT BE REVIEWED. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROTAPER UNIVERSAL BROKE DURING USE. THE SEPARATED PIECE COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36138 PROTAPER UNIVERSAL 21MM-F2 FILE, PULP CANAL, ENDODONTIC EKS DENTSPLY MAILLEFER NA 070178

    Patients

    Seq Age Sex Outcome Treatment
    1