BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 3

    MDR report key: 24324534 · Received February 12, 2026

    Report

    Report Number
    8031010-2026-00011
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Report Date
    March 6, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT: HAVE ALL THE BROKEN PARTS BEEN RETRIEVED FROM PATIENT¿S MOUTH? YES. HAS ANY FURTHER MEDICAL OR SURGICAL TREATMENT BEEN NECESSARY AFTER THE EVENT? NO. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: SUMMARY: INVOLVED PRODUCT THAT DIDN'T GIVE SATISFACTION WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED INSTRUMENT IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1920354). ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. POTENTIAL ROOT CAUSES MAY BE INCORRECT TECHNIQUE, OVERUSE, PATIENT CONDITION AND BEHAVIOR DURING TREATMENT OR MATERIAL ISSUE (NO ANALYSIS OF THE START-X TIP 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.

    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
    383703 START-X TIP EMS INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1920354

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown