BEUDAMED
    FDA Adverse Event Death Summary report: N

    30K FSI-PWR-1000 INSERT,PACKED

    MDR report key: 18707578 · Received February 14, 2024

    Report

    Report Number
    2424472-2024-00361
    Event Type
    Death
    Date Received
    February 14, 2024
    Date of Event
    February 8, 2024
    Report Date
    September 11, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003807991
    PMA / PMN Number
    K052334
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR: DHR WAS REVIEWED AND EVERYTHING MEET SPECIFICATION. NO DEVIATION FOUND. INSERT DID NOT RECEIVE. BASE ON INVESTIGATION PRODUCT WAS IN BUL. FAILURE MODE - BROKEN TIP. ROOT CAUSE - UNEXPECTED FAILURE TYPE. CONCLUSION CODE - UNEXPECTED FAILURE.

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY 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

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT INVOLVED IN THIS INCIDENT DIED DUE TO CARDIAC ARREST. THE PATIENT'S SPOUSE REPORTED THAT THE PATIENT DIED ON (B)(6) 2024. THE SPOUSE REPORTED THAT THE PATIENT HAD COMPLICATIONS FROM THE SURGERY TO REMOVE THE BROKEN PIECE OF THE DEVICE THAT WAS INGESTED AND WAS IN AND OUT OF THE HOSPITAL MANY TIMES SINCE THE SURGERY. THE SPOUSE ALLEGES, "I CANNOT BEGIN TO EXPRESS TO YOU THE EXTREME PAIN AND STRESS THIS HAS CAUSED HIM, SO MUCH TO THE POINT HE COULDN¿T TAKE IT ANY LONGER.¿

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-1000 INSERT, PACKED BROKE DURING USE AND THE PATIENT SWALLOWED THE BROKEN PART. THE PATIENT WAS SEEN IN THE HOSPITAL, HAD IMAGING TO DETERMINE LOCATION OF THE SEPARATED INSTRUMENT, AND IT WAS RETRIEVED IN THE OR OF THE LOCAL HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136269 30K FSI-PWR-1000 INSERT,PACKED SCALER, ULTRASONIC ELC DENTSPLY LLC 00106163 D003807991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death