BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 5

    MDR report key: 22913068 · Received August 28, 2025

    Report

    Report Number
    8031010-2025-00147
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    February 3, 2025
    Report Date
    September 23, 2025
    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

    THE INVESTIGATION RESULTS FOR THIS COMPLAINT ARE. A START-X TIP EMS INSERT 5 WAS RETURNED IN LOOSE. INSTRUMENT IS BROKEN IN THE MIDDLE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERN. NO UNUSED DEVICE IS AVAILABLE FOR FURTHER EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1880236). WE CANNOT RULE ON THE COMPLIANCE OF THE POWER SETTINGS SELECTED BY THE CUSTOMER IN COMPARISON WITH THE ONES RECOMMENDED BY MAILLEFER BECAUSE CUSTOMER'S GENERATOR BRAND AND MODEL ARE UNKNOWN. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. GENERALLY SPEAKING, SEVERAL OTHER FACTORS MAY CONTRIBUTE TO BREAKAGE ISSUE, SUCH AS USURY, PRESSURE OR INCORRECT TECHNIQUE. ALL OF THESE FACTORS MAY AFFECT THE LONGEVITY OF THE TIP.

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE 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 5 TIP BROKE DURING USE. THE BROKEN PARTS HAVE BEEN RETRIEVED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697862 START-X TIP EMS INSERT 5 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1880236

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown