BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGESEQUEL SAPPHIRE

    MDR report key: 17455820 · Received August 3, 2023

    Report

    Report Number
    3008857765-2023-00007
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 19, 2023
    Report Date
    August 3, 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, PATIENT WAS REFERRED TO GP FOR FINAL RESTORATION. PATIENT WAS TOLD THAT THEY WOULD MONITOR THE HEALING BUT 3-6MM REMAIN IN THE PATIENTS TOOTH. POSSIBLE FUTURE EXTRACTION. FOLLOW-UP APPOINTMENT IS SCHEDULED IN APPROX. 3 MONTHS. MANUFACTURER WILL REACH BACK OUT AT THE 3 MONTH MARK TO COLLECT ANY NEW INFORMATION TO BE PROVIDED FOR THE FOLLOW-UP REPORT. THE HEALTH EFFECT CLINICAL CODE IS CURRENTLY 2428: TOOTH FRACTURE AS THE TOOTH HAS YET TO BE EXTRACTED, BUT THE FILE IS STUCK IN THE TOOTH AND HAS CURRENTLY CAUSED DAMAGE TO THE TOOTH. WHEN/IF THE FOLLOW-UP INFORMATION COMES FROM THE DISTRIBUTOR/DENTIST, THE FOLLOW-UP REPORT WILL IDENTIFY TOOTH LOSS AS THE CLINICAL CODE. THE CURRENT MEDICAL DEVICE PROBLEM CODE IS 1069: BREAK. DR. (B)(6) PROVIDED TWO DIFFERENT SPEED RANGES DURING THE CALL. FIRST STATING 400-550 AND LATER STATING HE ALWAYS USES 500-650 RPM. CUSTOMER SERVICE AGENT REVIEWED THAT SPEED SHOULD NOT EXCEED 400 RPM.

    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. IN THIS EVENT IT WAS REPORTED BY THE DENTIST, DR. (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 PATIENT WAS REFERRED TO GP FOR FINAL RESTORATION. PATIENT WAS TOLD THAT THEY WOULD MONITOR THE HEALING BUT 3-6MM REMAIN IN THE PATIENTS TOOTH. POSSIBLE FUTURE EXTRACTION. FOLLOW-UP APPOINTMENT IS SCHEDULED IN APPROX. 3 MONTHS. THE FILES AND THE PACKAGING ARE NOT AVAILABLE FOR TESTING AND/OR INSPECTION. THE LOT NUMBER INFORMATION WAS RETRIEVED. DR. (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). THIS IS THE INITIAL REPORT, AND AS OF (B)(6) 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
    951154 EDGESEQUEL SAPPHIRE ENDODONTIC FILE EKS US ENDODONTICS, LLC. ES150425 093021057

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention