BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 19689842 · Received July 8, 2024

    Report

    Report Number
    2515379-2024-00031
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Report Date
    July 26, 2024
    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 7-23-2024: PRODUCT NOT RETURNED, HOWEVER IMAGE IN CASE DEPICTS 1 V3 RING UNIVERSAL BLUE (NEW AND IMPROVED DESIGN V5) WITH 1 OF THE TYNES BROKEN OFF. OVERMOLDING DATE CODES ARE NOT VISIBLE WITH PROVIDED IMAGE. DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). RETAIN 7-23-2024: FINAL PACKAGING PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM FOR ITEM#: 759870, BATCH#: 06603963 WAS INSPECTED AS PER 0290-IP-7.5-60-58 AND MEET ALL REQUIREMENTS. (NWV). DHR 7-23-2024: DHR FOR ITEM#: 659760V, BATCH#: 06616069 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 REFL. WORK ORDER: (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED 2 DIFFERENT OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS FOR ITEM#: 759870, BATCH#: 06603963 (V5 RING UNIVERSAL ¿ PALODENT). THE OVER-MOLDING WORK ORDER IS ONLY TO MOLD THE TYNES TO THE SPRING. DHR REVIEW 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. (NWV).

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT 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
    861736 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 06616069 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown