BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGETAPER PLATINUM

    MDR report key: 17306211 · Received July 12, 2023

    Report

    Report Number
    3008857765-2023-00003
    Event Type
    Injury
    Date Received
    July 12, 2023
    Date of Event
    March 15, 2023
    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 #1261 BECAUSE TECHNICALLY THE DEVICE DID BREAK UNEXPECTEDLY. BUT, DURING THE ATTEMPT TO DIG OUT THE FILE, IT WAS FOUND THAT THE TOOTH WAS FURTHER DECAYED THAN ALREADY KNOWN, AND THE DECISION WAS MADE TO EXTRACT THE TOOTH AS PROGNOSIS WAS POOR. SEE ORIGINAL STATEMENT: "IN THAT CASE, HE EXTRACTED THE TOOTH BECAUSE THERE WAS ALSO SIGNIFICANT DECAY PRESENT AS WELL AND PROGNOSIS WAS POOR BEFORE THE PROCEDURE BEGAN." THEREFORE, EXTRACTION IS NOT DIRECTLY DUE TO THE FAILURE OF THE MEDICAL DEVICE.

    Description of Event or Problem · 0

    "THE CLINICIAN REPORTED A CASE WHERE AN S1 (ETS125HT) SEPARATED ON A PATIENT, ON A MOLAR TOOTH, FROM A PACK OF FILES. IN THIS CASE, HE EXTRACTED THE TOOTH BECAUSE THERE WAS ALSO SIGNIFICANT DECAY PRESENT AS WELL AND PROGNOSIS WAS POOR BEFORE THE PROCEDURE BEGAN"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771448 EDGETAPER PLATINUM ENDODONTIC FILE EKS US ENDODONTICS, LLC. ETS125HT 122022014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability