BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 19200888 · Received April 29, 2024

    Report

    Report Number
    2515379-2024-00022
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Report Date
    May 5, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659760V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: RETURN: 5-2-2024: PRODUCT NOT RETURNED; IMAGE IN CASE DEPICTS 1 PALODENT V3 NARROW/DARK BLUE RING (NEW AND IMPROVED DESIGN V5) WITH A BROKEN TYNE. OVER-MOLDING DATE CODES CONFIRMED ¿B¿ FOR FEBRUARY AND ¿N¿ FOR 2022. PRODUCT DOES NOT MEET SPECIFICATIONS, DHR AND RETAIN EVALUATION WILL BE CONDUCTED. (NWV). RETAIN: 5-2-2024: FINAL PACKAGING PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RING OVER-MOLDING RETAIN FROM ITEM#: 759880, BATCH#: 05173195 WAS PULLED, REVIEWED, AND DEEMED ACCEPTABLE AS PER 0290-IP-7.5-60-58 AND MEET ALL FORM/FIT/FUNCTION. (NWV). DHR: 5-2-2024: DHR FOR ITEM#: 659700V, BATCH#: 05270343 HAS BEEN PULLED AND REVIEWED. DHR REVIEW DID NOT INDICATE ANY PRODUCTION ISSUES WHILE PACKAGING/LABELING THE PALODENT V3 STARTER KIT. WORK ORDER: (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDER/RUN ITEM#: 759880, BATCH#: 05173195 (V5 RING UNIVERSAL ¿ PALODENT; MFG 02-2022). THE OVER-MOLDING WORK ORDERS 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

    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. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022343 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05270343 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown