BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-PWR-FG-100 INSERT,PKD

    MDR report key: 20734330 · Received November 20, 2024

    Report

    Report Number
    2424472-2024-00405
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Report Date
    January 16, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: DURING THE DHR REVIEW IT WAS NOTICED THAT LOT NUMBER 00104248 WITH MANUFACTURING CODE 23223 CORRESPONDS TO INSERT 30K FSI-SLI-1000 PART NUMBER 81570 WITH TIP LOT NUMBER 34 INSTEAD OF INSERT 30K FSI-SLI-100. DURING THE DHR REVIEW NO PRODUCT DEVIATIONS WERE IDENTIFIED. NO ISSUES IDENTIFIED ON THE TIP AN CONNECTING BODY BRAZING OPERATION. THE INSERT TIP WAS BRAZED BY USING AN INDUCTION BRAZING MACHINE AND NO QUALITY DEFECTS WERE IDENTIFIED. IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. BASED ON THE TIP BREAKAGE QUESTIONNAIRE FOR THIS COMPLAINT, THE INSERT IS QUESTION IS A 30K FSI-PWR-FG-100 WITH MANUFACTURING DATE CODE 232223 LOT NUMBER 00104248. THE INSERT INVOLVED HAS NOT BEEN RECEIVED FOR INVESTIGATION. RETAINED SAMPLES AND DHR WERE PULLED AND REVIEWED. THE DHR COMPRISES THE MANUFACTURING HISTORY OF THE INSERT WITH THE INTENT TO KNOW IF THERE WERE QUALITY ISSUES IN THE MANUFACTURING PROCESS RELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT PER 21 CFR 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 30K FSI-PWR-FG-100 INSERT, PKD ALLEGEDLY TIP BROKE DURING USE AND THE PATIENT SWALLOWED THE BROKEN PART. PATIENT WENT TO THE HOSPITAL FOR X-RAY, AT ONE WEEK FOLLOW UP APPOINTMENT IT WAS DETERMINED BY X-RAY TIP WAS STUCK IN PATIENT'S LOWER BOWEL. FOLLOW UPS ARE STILL ON GOING AS OF THIS MDR. REQUESTED FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431830 30K FSI-PWR-FG-100 INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00104248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown