BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 22860372 · Received August 21, 2025

    Report

    Report Number
    2515379-2025-00019
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Report Date
    November 13, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659760V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: (B)(6) 2025: PRODUCT NOT RETURNED, IMAGE IN CASE DEPICTS A V3 PALODENT UNIVERSAL BLUE RING (NEW AND IMPROVED V5 DESIGN) WITH BROKEN TYNE AS THE CUSTOMER DESCRIBES. OVERMOLDING DATE CODES ARE NOT LEGIBLE DUE TO THE FOCUS/QUALITY OF THE IMAGE. DHR AND RETAIN EVALUATION (IF APPLIABLE) WILL BE CONDUCTED. (NWV). RETAIN: (B)(6) 2025: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING ITEM# 759870 LOT#¿S 05091136, 05091139, 05104862, 05104866 & 05104867 ARE NOT AVAILABLE FOR REVIEW AS PER 0290-WI-8.2-07 WHICH STATES RETENTION SAMPLES MUST BE MAINTAINED FOR A MINIMUM OF SIX MONTHS (PRODUCED 12-2021 & 01-2022). (NWV) DHR: 8-21-2025: DHR FOR ITEM# 659760V LOT# 05122446 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 5 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 12-2021), (B)(4) (PRODUCED 12-2021), (B)(4) (PRODUCED 12-2021), (B)(4) (PRODUCED 01-2022) & (B)(4) (PRODUCED 01-2022). 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, 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. 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 REFIL BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220868 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05122446 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown