BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 23319129 · Received October 16, 2025

    Report

    Report Number
    2515379-2025-00023
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Report Date
    October 21, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659760V1
    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

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803.

    Additional Manufacturer Narrative · 0

    RETURN: 10-17-2025: PRODUCT NOT RETURNED, IMAGE IN CASE DEPICTS 1 V3 PALODENT UNIVERSAL BLUE RING (NEW AND IMPROVED V5 DESIGN) WITH BROKEN TYNE. OVER MOLDING DATE CODES VERIFIED ¿L¿ FOR DECEMBER AND ¿P¿ FOR 2024. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). RETAIN: 10-17-2025: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVER MOLDING ITEM#: 759870, LOT#¿S: 09261537, 09261538 & 09329082 WERE REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND WERE FOUND ACCEPTABLE. (NWV). DHR: 10-17-2025: DHR FOR ITEM#: 659760V, LOT#: 09323412 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY PRODUCTION ISSUES WHILE PACKAGING/LABELING THE PALODENT V3 UNIV 2 RING REFILL. WORK ORDER: (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED 3 OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS OF ITEM: 759870 (V5 RING UNIVERSAL - PALODENT) LOTS IN WHICH WERE 09261537 (PRODUCED 12-2024), 09261538 (PRODUCED 12-2024) & 09329082 (PRODUCED 12-2024). DHRS FOR EACH MOLDING WORK ORDER HAVE ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT IDENTIFY ANY ISSUED DURING PRODUCTION WITH ALL INSPECTIONS PERFORMED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER 0290-WI-7.5-60-14 & 0290-IP-7.5-60-58. (NWV).

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A PALODENT V3 UNIV 2 RING REFIL RING BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253304 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 9323412 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown