BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 16232025 · Received January 24, 2023

    Report

    Report Number
    2515379-2023-00061
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    January 30, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    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: 1. (B)(6) 2023: PRODUCT NOT RETURNED BUT IMAGE OF V3 RING WITH A BROKEN TYNE WAS PROVIDED/ATTACHED IN THE CASE. THE OVERMOLDING DATE ID CODE FOR 1 SIDE READS ¿G¿ FOR (B)(6) AND ¿N¿ FOR 2022. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). 2. (B)(6) 2023: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING LOT OF UNIVERSAL RINGS BATCHES 05764633 & 05764634 WERE REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND WERE FOUND ACCEPTABLE. (NWV). 3. (B)(6) 2023: DHR FOR LOT# 05758799 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 05758799 IS THE PACKAGING WORK ORDER WHICH UTILIZED 2 OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS OF ITEM 759870 (UNIVERSAL RING) IN WHICH WERE 05764633 & 05764634 (BOTH PRODUCED (B)(6) 2022). DHRS FOR MOLDING WORK ORDERS 05764633 & 05764634 HAVE ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEWS DID NOT INDICATE ANY ISSUES IN 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

    INVESTIGATION FINDINGS: 1-23-2023: PRODUCT NOT RETURNED BUT IMAGE OF V3 RING WITH A BROKEN TYNE WAS PROVIDED/ATTACHED IN THE CASE. THE OVERMOLDING DATE ID CODE FOR 1 SIDE READS ¿G¿ FOR JULY AND ¿N¿ FOR 2022. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING LOT OF UNIVERSAL RINGS BATCHES (B)(4) WERE REVIEWED AND INSPECTED (B)(4) AND WERE FOUND ACCEPTABLE. (NWV) DHR FOR LOT# 05758799 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 2 OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS OF ITEM 759870 (UNIVERSAL RING) IN WHICH WERE (B)(4) (BOTH PRODUCED 07-2022). DHRS FOR MOLDING WORK ORDERS (B)(4) HAVE ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEWS DID NOT INDICATE ANY ISSUES IN 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 BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594652 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05758799

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown