BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM

    MDR report key: 9533801 · Received December 30, 2019

    Report

    Report Number
    2320721-2019-00273
    Event Type
    Malfunction
    Date Received
    December 30, 2019
    Report Date
    March 4, 2020
    Manufacturer
    TULSA DENTAL PRODUCTS LLC
    Product Code
    EKS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER RETURNED 1 UNOPENED FILE IN BLISTER CELL PACKAGING FROM LOT# 0000216824. THE BROKEN FILE REFERENCED IN THE EVENT WAS NOT RETURNED FOR INVESTIGATION. USING MICROSCOPE VISUALLY CHECKED FILE. NO MANUFACTURING DEFECTS OR MARKINGS NOTED ON FILE. LORI OGLE MEASURED THE FILE USING TM-0061 ON NIKON 4. SPEC @ 3MM SPEC @ 9MM .450MM-.490MM .825MM-.865MM 1) .482MM .839MM RETURNED PRODUCT HAS BEEN ANALYZED AND WAS FOUND IN COMPLIANCE WITH SPECIFICATIONS. NO BROKEN FILES WERE RETURNED. NO FAULT FOUND WITH RETURNED PRODUCT.

    Additional Manufacturer Narrative · 1

    THEREFORE, BECAUSE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WAVEONE GOLD RECIPROCATING FILE PRIMARY BROKE DURING USE. THE DOCTOR WAS UNABLE TO REMOVE THE FILE, THE PATIENT'S TOOTH WAS EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328539 WAVEONE GOLD RECIPROCATING FILE PRIMARY 25MM FILE, PULP CANAL, ENDODONTIC EKS TULSA DENTAL PRODUCTS LLC NA 0000216824

    Patients

    Seq Age Sex Outcome Treatment
    1