BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE ASSORTED FILE STERILE 25MM

    MDR report key: 11182469 · Received January 15, 2021

    Report

    Report Number
    8031010-2020-00285
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Report Date
    January 14, 2021
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EKS
    PMA / PMN Number
    NA#S-P#NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED FILE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (1251830). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A WAVEONE FILE BROKE DURING USE. THE SEPARATED PIECE COULD NOT BE RETRIEVED. NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77752 WAVEONE ASSORTED FILE STERILE 25MM FILE, PULP CANAL, ENDODONTIC EKS DENTSPLY MAILLEFER NA 1251830

    Patients

    Seq Age Sex Outcome Treatment
    1