BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 17968493 · Received October 19, 2023

    Report

    Report Number
    2515379-2023-00103
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Report Date
    October 26, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659760V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    10-19-2023: PRODUCT NOT RETURNED, HOWEVER IMAGE IN CASE DEPICTS 1 V3 RING UNIVERSAL BLUE (NEW AND IMPROVED DESIGN V5) WITH ONE OF THE TYNES BROKEN OFF. OVERMOLDING DATE CODES ¿B¿ FOR FEBRUARY AND ¿O¿ FOR 2023. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV) 10-19-2023: FINAL PACKAGING PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RING OVER-MOLDING RETAIN FROM ITEM# (B)(4) BATCHES 06030418, 06030419, 06030420, 06067451, 06067454 & 06067449 HAVE BEEN PULLED, REVIEWED, AND DEEMED ACCEPTABLE AS PER 0290-IP-7.5-60-58 AND MEET ALL FORM/FIT/FUNCTION. (NWV) 10-19-2023: DHR FOR ITEM# (B)(4) BATCH# 06196971 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 6 DIFFERENT OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS FOR ITEM# (B)(4) BATCHES 06030418, 06030419, 06030420, 06067451, 06067454 & 06067449. THE OVER-MOLDING WORK ORDER IS ONLY TO MOLD THE TYNES TO THE SPRING. DHR REVIEWS FOR ALL MOLDING PRODUCTION ORDER FOR ITEM# (B)(4) BATCHES 06030418, 06030419, 06030420, 06067451, 06067454 & 06067449 DID NOT INDICATE ANY PRODUCTION ISSUES, NOR ANY COMMENTS NOTED WITH ALL INSPECTIONS PERFORMED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER 0290-IP-7.5-60-58. NOTE THAT THE TRACEABILITY OF THE RETURNED PRODUCT OVERMOLDING DATE CODES FOR ¿B¿ FOR FEBRUARY AND ¿O¿ FOR 2023 DOES NOT TRACE BACK TO ANY OF THE OVERMOLDING ITEM# (B)(4) 6 BATCHES THAT WERE PICKED TO ITEM# (B)(4) BATCH# 06196971 (ALL WERE PRODUCED IN NOVEMBER, ¿K¿ & ¿N¿ OR DECEMBER 2022, DATE CODE ¿L¿ & ¿N¿). (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 PALODENT V3 UNIV 2 RING REFIL BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749626 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 06196971 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown