BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEONE PLATINUM

    MDR report key: 20322758 · Received September 27, 2024

    Report

    Report Number
    3008857765-2024-00003
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 27, 2024
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS REFERRED TO AN ENDODONTIST. THE FOLLOW-UP APPOINTMENT IS SCHEDULED, BUT THE DATE WAS NOT SHARED WITH THE MANUFACTURER. IF THE FOLLOW-UP APPOINTMENT LEADS TO A TOOTH BEING PULLED, US ENDODONTICS WILL RE-SUBMIT THIS ADVERSE EVENT AS A SERIOUS INJURY. THIS REPORT IS BEING SUBMITTED PAST THE 30 DAY REQUIRED TIMEFRAME FOR MALFUNCTIONS DUE TO WEBTRADER CRASHING AND WITH MULTIPLE IT MEMBERS UNABLE TO GET IT UP AND RUNNING QUICKLY ENOUGH FOR THE DEADLINE.

    Description of Event or Problem · 0

    COMPLAINT FROM MINTY TEETH. FILE SEPARATION OF (B)(4), THE FILE WAS USED ONCE, AND NOT AUTOCLAVED. THE SPEED AND TORQUE SETTINGS WERE THOSE OF WAVEONE 8:1. THE FILE SEPARATED IN THE TOOTH AND WAS NOT ABLE TO BE REMOVED. 10MM WAS LEFT IN THE TOOTH, AND THE APPOINTMENT WAS CONCLUDED BY SENDING THEM TO AN ENDODONTIST. THERE IS A FOLLOWUP APPOINTMENT SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372883 EDGEONE PLATINUM ENDODONTIC FILE EKS US ENDODONTICS, LLC. EOPPRI25 051024393

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown