BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT UNIVERSAL MATRIX SYSTEM INTRO KIT (PV3)

    MDR report key: 24092683 · Received January 16, 2026

    Report

    Report Number
    2515379-2026-00004
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Report Date
    March 24, 2026
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659600V0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS; RETURN 3-2-2026: RETURNED PRODUCT 1 PALODENT UNIVERSAL BLUE RING (NEW AND IMPROVED V5 DESIGN) WITH A BROKEN TYNES AS THE CUSTOMER DESCRIBES. OVERMOLDING DATE CODES VERIFIED ¿C¿ FOR MARCH AND ¿P¿ FOR 2024. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV) RETAIN 3-2-2026: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING ITEM# 759870 LOT#¿S 08151425 & 08151426 WERE REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND WERE FOUND ACCEPTABLE. (NWV) DHR 3-2-2026: DHR FOR ITEM# 659600V LOT# 08122470 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 REFIL. WORK ORDER 05122447 IS THE PACKAGING WORK ORDER WHICH UTILIZED 2 OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS OF ITEM 759870 (V5 RING UNIVERSAL - PALODENT) IN WHICH WERE 08151425 (PRODUCED 03-2024) & 08151426 (PRODUCED 03-2024). 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).

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, 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

    IN THIS EVENT IT IS REPORTED THAT A PALODENT UNIVERSAL MATRIX SYSTEM INTRO KIT (PV3) RING FRACTURED WHEN PLACED AROUND THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61071 PALODENT UNIVERSAL MATRIX SYSTEM INTRO KIT (PV3) INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 08122470 D002659600V0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown