BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTAPER NEXT ROTARY FILES X1 25MM

    MDR report key: 11868445 · Received May 22, 2021

    Report

    Report Number
    2320721-2021-00041
    Event Type
    Malfunction
    Date Received
    May 22, 2021
    Report Date
    May 22, 2021
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    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. CUSTOMER RETURNED 2X PTNX125 LOT NUMBER 0000275139 IN SEALED PACK. CHECKED UNDER MICROSCOPE AND FOUND NO MANUFACTURING MARKS OR DEFECTS. FILES WERE MEASURED WITHIN SPECIFICATIONS BY LORI OGLE AND PASSED TWIST TEST.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A PROTAPER NEXT FILE SEPARATED. THE FILE WAS NOT RETRIEVED, AND WAS INCORPORATE INTO THE FILLING. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764402 PROTAPER NEXT ROTARY FILES X1 25MM FILE, PULP CANAL, ENDODONTIC EKS NA 0000257126-2

    Patients

    Seq Age Sex Outcome Treatment
    1