BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGESEQUEL SAPPHIRE

    MDR report key: 17306215 · Received July 12, 2023

    Report

    Report Number
    3008857765-2023-00002
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    November 1, 2022
    Report Date
    July 5, 2023
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    PMA / PMN Number
    N/AN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE PROBLEM CODE ON H6 IS SET AT #1126 DUE TO THE DENTIST (USER) ACKNOWLEDGING THAT HE USED THE WRONG TORQUE SETTINGS. THE FAULT WAS NOT ON THE MANUFACTURER. MANUFACTURER IFU/DFU CLEARLY STATES THE PROPER SPEED AND TORQUE SETTINGS TO BE USED WITH EVERY DEVICE.

    Description of Event or Problem · 0

    "CLINICIAN WAS INSTRUMENTING ON TOOTH #14 WHEN THE FILE SEPARATED. FILE WAS NOT ABLE TO BE REMOVED, AND A FOLLOW-UP APPOINTMENT WAS TO BE DETERMINED AND THE PATIENT WAS REFERRED TO A SPECIALIST FOR RETREATMENT ((B)(6) 2022). FOLLOW-UP FROM DR. (B)(6) ON (B)(6) 2022 (TWO WEEKS LATER) WAS THAT THE PATIENT OPTED FOR EXTRACTION DUE TO COST. DR. (B)(6) ALSO STATED THAT HE HAD GAINED PATENCY WITH AN EDGE ENDO #10 K-FILE AND ACKNOWLEDGED HE WAS AT FAULT FOR USING IMPROPER TORQUE SETTINGS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771452 EDGESEQUEL SAPPHIRE ENDODONTIC FILE EKS US ENDODONTICS, LLC. ES250825 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability