BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 3

    MDR report key: 24505587 · Received March 4, 2026

    Report

    Report Number
    8031010-2026-00028
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Report Date
    March 4, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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. SUMMARY: INVOLVED START-X TIP EMS INSERT 3 THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. FOR INFORMATION, THE PROVIDED PICTURE HAS A TOO LOW RESOLUTION AND IS UNEXPLOITABLE. NO FURTHER ANALYSIS CAN BE MADE AS THE DAMAGED PRODUCT IS NOT AVAILABLE PHYSICALLY (ANALYSIS UNDER HIGH MAGNIFICATION IS NEEDED). NO UNUSED INSERT IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1923170). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE, EXCESSIVE WEAR, PATIENT CONDITION AND BEHAVIOR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE BROKEN FRAGMENTS POSSIBLE). IN ADDITION, THERE ARE FURTHER CIRCUMSTANCES ON THE CONDITIONS IN DENTISTRY (USED DISINFECTANTS, TRAINING/KNOWLEDGE STATUS), OR ANY OTHER ENVIRONMENTAL CONDITIONS, WHICH ARE UNKNOWN TO US AND MAY ALSO HAVE AN IMPACT ON THE REPORTED FAILURE MODE. ROOT CAUSES ARE NOT IDENTIFIED. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A START-X TIP EMS INSERT 3 BROKE DURING USE. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT'S MOUTH. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573259 START-X TIP EMS INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1923170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown