BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 3

    MDR report key: 21699094 · Received March 26, 2025

    Report

    Report Number
    8031010-2025-00043
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Report Date
    May 5, 2025
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    RETURNED START-X TIP EMS INSERT 3 IS 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 #1875249). 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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A START-X TIP EMS INSERT 3 BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098981 START-X TIP EMS INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1875249

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown