BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGESEQUEL SAPPHIRE

    MDR report key: 17466838 · Received August 4, 2023

    Report

    Report Number
    3008857765-2023-00008
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 4, 2023
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    PMA / PMN Number
    N/AN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL INPUT: IN THIS CASE, THE ORIGINAL REPORT DID NOT HAVE MUCH INFORMATION REGARDING THE EVENT OTHER THAN THE SEPARATION OCCURRED AND THAT IT HAPPENED ON A MOLAR TOOTH. (B)(6) PROVIDED TWO DIFFERENT SPEED RANGES DURING THE INTAKE CALL. FIRST, HE STATED THAT HE USED A SPEED OF 400-500 RPM AND LATER STATED THAT HE ALWAYS USES 500-650 RPM. THE CUSTOMER SERVICE REPRESENTATIVE REVIEWED THAT SPEED SHOULD NOT EXCEED 400 RPM (REFERENCED THE PRODUCT'S DIRECTIONS FOR USE). ADDITIONAL INFROMATION STATED THAT THE EXTRACTION WAS POSSIBLE, BUT THAT NO FINAL PATIENT OUTCOME OR FOLLOW-UP APPOINTMENT INFORMATION WAS YET TO BE PROVIDED. SPEED WAS INDICATED TO BE BETWEEN 420-460 RPM AND THE DENTIST WOULD CONTINUE TO MONITOR THE PATIENT. APPROXIMATELY 5 MM OF THE ROTARY FILE SEPARATED IN THE TOOTH AND WAS UNABLE TO BE REMOVED. THE HEALTH EFFECT CLINICAL CODE IS CURRENTLY 2428: TOOTH FRACTURE AS THE TOOTH HAS YET TO BE EXTRACT, BUT THE FILE IS STUCK IN THE TOOTH AND HAS CURRENTLY CAUSED DAMAGE TO THE TOOTH. WHEN/IF FOLLOW-UP INFORMATION IS PROVIDED BY THE DISTRIBUTOR OR DENTIST, THE FOLLOW-UP REPORT WILL IDENTIFY TOOTH LOSS AS THE CLINICAL CODE. THE CURRENT MEDICAL DEVICE PROBLEM CODE IS 1069: BREAK.

    Description of Event or Problem · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. INITIAL INFORMATION (07/19/2023): IN THIS EVENT IT WAS REPORTED BY THE DENTIST, (B)(6), THAT HE HAD 3 FILES SEPARATE. HE STATED THAT HE USED A BRAND-NEW SYBRON ELECTRIC GEAR REDUCTION HANDPIECE. IN THE CASE OF THIS SPECIFIC EVENT REPORT, THE DENTIST HAD DIFFICULTY REMEMBERING ANY SPECIFICS OF THE CASE OTHER THAN THAT THE SEPARATION OCCURRED AND THAT IT HAPPENED ON A MOLAR TOOTH. THE FILE WAS UNABLE TO BE REMOVED AND ANYWHERE FROM 3-6 MM OF THE FILE REMAINED INSIDE THE CANAL APPROXIMATELY 2 MM FROM THE APEX. HE COULD NOT DEFINITIVELY PROVIDE FINAL PATIENT OUTCOME INFORMATION OR FOLLOW-UP APPOINTMENT INFORMATION. THE FILES AND THE PACKAGING ARE NOT AVAILABLE FOR TESTING AND/OR INSPECTION. THE LOT NUMBER INFORMATION WAS RETRIEVED. DR. MELIDEO PROVIDED TWO DIFFERENT SPEED RANGES DURING THE INTAKE CALL. FIRST, HE STATED THAT HE USED A SPEED OF 400-500 RPM AND LATER STATED THAT HE ALWAYS USES 500-650 RPM. THE CUSTOMER SERVICE REPRESENTATIVE REVIEWED THAT SPEED SHOULD NOT EXCEED 400 RPM (REFERENCED THE PRODUCT'S DIRECTIONS FOR USE). ADDITIONAL INFORMATION (07/28/2023): THE ADVERSE EVENT WAS OFFICIALLY REPORTABLE ONCE PROVIDED WITH THE INFORMATION THAT IT WAS EXPRESSED THAT EXTRACTION WAS POSSIBLE, BUT THAT NO FINAL PATIENT OUTCOME OR FOLLOW-UP APPOINTMENT INFORMATION WAS YET TO BE PROVIDED. SPEED WAS INDICATED TO BE BETWEEN 420-460 RPM. WILL CONTINUE TO BE MONITORED. APPROXIMATELY 5 MM OF THE ROTARY FILE SEPARATED IN THE TOOTH AND WAS UNABLE TO BE REMOVED. THIS IS THE INITIAL REPORT, AND AS OF 08/04/2023, THE TOOTH HAS NOT YET BEEN EXTRACTED, SO THE REPORT IS ONLY AS A MALFUNCTION. IF THE TOOTH IS EXTRACTED, A FOLLOW-UP REPORT WILL BE SUBMITTED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334172 EDGESEQUEL SAPPHIRE ENDODONTIC FILE EKS US ENDODONTICS, LLC. ES150425 093021057

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention