BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 23528522 · Received November 11, 2025

    Report

    Report Number
    2515379-2025-00030
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Report Date
    November 14, 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

    INVESTIGATION RESULTS: RETURN - (B)(6) 2025: PRODUCT NOT RETURNED, IMAGE IN CASE DEPICTS 1 V3 PALODENT UNIVERSAL BLUE RING (NEW AND IMPROVED V5 DESIGN) WITH BROKEN TYNE. OVERMOLDING DATE CODES COULDN¿T BE COMPLETELY VERIFIED AS THE IMAGE DOES NOT CLEARLY SHOW THE MONTH MOLDED, HOWEVER THE YEAR IS VISIBLE AND READS ¿O¿ FOR 2023. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. NOTE THAT THE SUSPECT PRODUCT DOES NOT TRACE BACK TO ITEM# 659760V LOT# 09323412 AS THIS PRODUCT WAS MANUFACTURED IN 12-2024 (DATE CODES WOULD BE ¿L¿ FOR (B)(6) AND ¿P¿ FOR 2024) HOWEVER, DUE TO THE NATURE OF THE CASE, DHR AND RETAIN EVALUATION WILL BE DOCUMENTED FOR ITEM# 659760V LOT# 09323412. (NWV). RETAIN 11-13-2025: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING ITEM# 759870 LOT#¿S 09261537, 09261538 & 09329082 WERE REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND WERE FOUND ACCEPTABLE. (NWV). DHR (B)(6) 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 REFIL. 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 (B)(4) (PRODUCED (B)(6) 2024), (B)(4) (PRODUCED (B)(6) 2024) & (B)(4) (PRODUCED (B)(6) 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 WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501736 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 9323412 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown