BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 16684674 · Received April 5, 2023

    Report

    Report Number
    2515379-2023-00069
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 10, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    5-10-2023: RETURNED PRODUCT V3 RING UNIVERSAL (NEW IMPROVED V5 RING) WITH 3 BROKEN TYNES. OVERMOLDING ID ¿E¿ MAY & ¿N¿ 2022. PRODUCT DOES NOT MEET SPECIFICATION, DHR REVIEW/RETAIN EVALUATION TO OCCUR. (NWV). 5-10-2023: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RING OVER-MOLDING RETAINS FROM BATCHES 05512213 & 05511630 WERE PULLED, REVIEWED, AND DEEMED ACCEPTABLE AS PER 0290-IP-7.5-60-58 AND MEET ALL FORM/FIT/FUNCTION. (NWV). 5-10-2023: DHR FOR ITEM# 659760V BATCH# 05511980 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 DIFFERENT OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS IN WHICH ARE 05512213 (PRODUCED 05-2022) & 05511630 (PRODUCED 06-2022). DHRS FOR EACH OF THESE MOLDING WORK ORDERS HAVE ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEWS DID INDICATE CONTAMINATION ISSUES IN PRODUCTION, HOWEVER THE OVERMOLDING PLASTIC IS REMOVED AND RE-OVERMOLDED AS PART OF NORMAL PROCESS. 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
    2284356 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05511980

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown