BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP SATELEC INSERT 3

    MDR report key: 24198863 · Received January 28, 2026

    Report

    Report Number
    8031010-2026-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Report Date
    February 13, 2026
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 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

    ADDITIONAL INFORMATION RECEIVED: WE RECEIVED THE FOLLOWING INFORMATION REGARDING THIS COMPLAINT: DID THE TIP BREAK DURING TREATMENT WITH BOTH PRODUCTS? YES. WAS A PATIENT INJURED? NO. HOW MANY PATIENTS ARE INVOLVED EXACTLY? THE CLINIC TELLS US THAT NO PATIENTS HAVE BEEN AFFECTED, ONLY THAT IT BROKE BEFORE WE STARTED USING IT. THIS IS A FOLLOW UP REPORT FOR THIS ADDITIONAL INFORMATION. INVESTIGATION RESULTS: SUMMARY: TWO START-X TIP SATELEC INSERTS 3 WERE RETURNED IN LOOSE. RETURNED DEVICES ARE BOTH BROKEN IN THE ACTIVE PART. NO MATERIAL DEFECT WAS FOUND DURING ANALYSIS OF THE RUPTURE PATTERNS. NO UNUSED DEVICE IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHRS REVIEW (BATCHES #1905251 AND #1912908). 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. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: HEALTH EFFECT - CLINICAL CODE - 4580. HEALTH EFFECT - IMPACT CODE - 4648. THE CORRECT CODES FOR THIS COMPLAINT ARE: HEALTH EFFECT - CLINICAL CODE - 4582. HEALTH EFFECT - IMPACT CODE - 2199. THIS IS A FOLLOW UP REPORT TO CORRECT THIS CODE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A START-X TIP SATELEC INSERT 3 TIP BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260377 START-X TIP SATELEC INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1905251 , 1912908

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown