BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 2

    MDR report key: 17479475 · Received August 8, 2023

    Report

    Report Number
    8031010-2023-00826
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 20, 2023
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: RETURNED START-X TIP EMS INSERT 2 IS ACTUALLY BROKEN IN THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED DEVICE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1772251). NO INFORMATION WAS GIVEN REGARDING TECHNIQUE, WE CANNOT RULE ON ITS COMPLIANCE WITH MAILLEFER'S RECOMMENDATIONS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. PATIENT OUTCOME - NO FURTHER INFORMATION RECEIVED AFTER 3 DOCUMENTED ATTEMPTS COMPLAINT WILL BE REOPENED IF FURTHER INFORMATION IS RECEIVED PER 8000-SOP-038. NO VIGILANCE RECEIVED AFTER 3 DOCUMENTED ATTEMPTS.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A START-X TIP EMS INSERT 2 BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR AND FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457793 START-X TIP EMS INSERT 2 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1772251

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown