BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFLEX

    MDR report key: 19430779 · Received May 30, 2024

    Report

    Report Number
    2416455-2024-00003
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 28, 2024
    Manufacturer
    COLTENE WHALEDENT INC.
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THE HYFLEX CM FILE FRACTURED IN THE PATIENTS TOOTH CLOSE TO THE SHANK, PROBABLY ABOUT 5MM AWAY FROM THE SHANK AT THE TOP OF THE FILE. THE FILE IN QUESTION WAS THE 04/40 SBH8310440. THIS FILE CAME FROM AN ASSORTED PACK SB60018460. THE CUSTOMER STATED THAT DUE TO THE LOCATION OF THE FRACTURE, IT COULD BE A PRODUCT DEFECT. DOCTOR WAS UNABLE TO RETRIEVE THE FILE IN THE TOOTH. THE CUSTOMER STATED THAT THE HYFLEX FILE WAS BEING USED TO SHAPE THE CANAL WHEN IT SEPARATED. THEY STATED THAT THERE WAS NO INJURY, THE DOCTOR PLACED CALCIUM HYDROXIDE IN THE TOOTH, PLACED A TEMPORARY FILLING, AND THEN REFERRED THE PATIENT TO AN ENDODONTIST. THE DOCTOR STATED THAT THE FILE WAS NOT ABLE TO BE RETRIEVED AND THEREFORE DID NOT REQUIRE SURGICAL INTERVENTION TO REMOVE. HOWEVER, THE HYFLEX FILE WAS LEFT IN THE PATIENT'S TOOTH WHICH IS NOT WHAT THE FILE IS INDICATED FOR. THEREFORE, OUT OF AN ABUNDANCE OF CAUTION AND PER 21 CFR 803, THIS EVENT WILL BE REPORTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099349 HYFLEX ROTARY FILE EKS COLTENE WHALEDENT INC. M43532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown