BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-FG-10S INS,PKD

    MDR report key: 21495803 · Received February 28, 2025

    Report

    Report Number
    2424472-2025-00205
    Event Type
    Malfunction
    Date Received
    February 28, 2025
    Report Date
    March 28, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS - 1. RETURN QTY. (B)(4), 30K FSI-SLI-10S FG-KD, (B)(6) BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# (B)(4) DUE: 12/31/2026 RESULT 3.03. MEETS SPEC DOES NOT MEET SPEC N/A. TIP CONDITION: - MEETS SPEC DOES NOT MEET SPEC N/A. STACK CONDITION MEETS SPEC DOES NOT MEET SPEC N/A. TESTED ON: G130 GAGE ID# (B)(4) DUE DATE: 03/31/2025 SET PRESSURE: 35 PSI. WATER FLOW: OUTPUT RATE: 35 PSI - MEETS SPEC DOES NOT MEET SPEC N/A. SPRAY: - MEETS SPEC DOES NOT MEET SPEC N/A. WATER LEAK: HP SEALING RING PROXIMAL RING DISTAL RING. SEAM LEAK N/A. VIBRATION: - MEETS SPEC DOES NOT MEET SPEC N/A. GRIP CONDITION: MEET DOES NOT MEET SPEC N/A. OTHER VISUAL OBSERVATION: INSERT TIP IS BROKEN AT THE EDM HOLE. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#(B)(4). DUE DATE:09/30/2025. THE TEMPERATURE WAS 73.4 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175). ALLEGED EVENT: CONFIRMED - NOT CONFIRMED. INVESTIGATION RESULTS -2. RETURN QTY. (B)(4), 30K FSI-SLI-10S FG-KN, (B)(6) BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# (B)(4) DUE: 12/31/2026 RESULT 3.07. MEETS SPEC DOES NOT MEET SPEC N/A . TIP CONDITION: - MEETS SPEC DOES NOT MEET SPEC N/A. STACK CONDITION MEETS SPEC DOES NOT MEET SPEC N/A. TESTED ON: G130 GAGE ID# (B)(4) DUE DATE: (B)(6) 2025 SET PRESSURE: 35 PSI. WATER FLOW: OUTPUT RATE: 35 PSI - MEETS SPEC DOES NOT MEET SPEC N/A. SPRAY: - MEETS SPEC DOES NOT MEET SPEC N/A. WATER LEAK: HP SEALING RING PROXIMAL RING DISTAL RING. SEAM LEAK N/A VIBRATION: - MEETS SPEC DOES NOT MEET SPEC N/A. GRIP CONDITION: MEET DOES NOT MEET SPEC N/A. OTHER VISUAL OBSERVATION: INSERT TIP IS BROKEN AT THE EDM HOLE. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#(B)(4). DUE DATE: (B)(6)2025. THE TEMPERATURE WAS 80.3 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175). ALLEGED EVENT: CONFIRMED - NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED 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 30K FSI-SLI-FG-10S INS,PKD INSERT BROKE DURING USE IN THE PATIENT'S MOUTH. THE BROKEN PART WAS SWALLOWED. THE PATIENT WAS EXAMINED BY THEIR PCP AND X-RAY CONFIRMED TIP WAS INGESTED. THE PCP IS FOLLOWING PROGRESS BUT THEY HAVE NOT RULED OUT SURGERY TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409376 30K FSI-SLI-FG-10S INS,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00096914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown