BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V3 RING UNIVERSAL (GREEN) 2 PACK

    MDR report key: 18543009 · Received January 19, 2024

    Report

    Report Number
    2515379-2024-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Report Date
    March 27, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    UDI-DI
    D002659900V1
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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 IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: RETURN (B)(6) 2024: PRODUCT NOT RETURNED; IMAGE IN CASE DEPICTS 2 PALODENT V3 UNIVERSAL RING (GREEN, V5 VERSION) OVERMODLING DATE CODES NOT VISIBLE WITH ATTACHED IMAGE. BOTH RINGS OBSERVED TO HAVE BROKEN TYNES CAUSING THE RINGS TO NO LONGER BE FUNCTIONAL. DHR AND RETAIN EVALUATION TO BE CONDUCTED. (NWV) RETAIN: (B)(6) 2024: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM OVERMOLDING LOT OF UNIVERSAL RINGS (B)(6) WERE REVIEWED AND INSPECTED PER (B)(4) AND WERE FOUND ACCEPTABLE. (NWV) DHR: (B)(6) 2024: DHR FOR ITEM# 403342 LOT# 06614879 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY PRODUCTION ISSUES WHILE PACKAGING/LABELING THE V3 RING UNIVERSAL (GREEN) 2 PACK. WORK ORDER (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED 1 V3 UNIVERSAL OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDER/RUN ITEM# 220004 IN WHICH WAS (B)(6) (PRODUCED 10-2022). DHR FOR MOLDING WORK ORDER (B)(4) HAS ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY ISSUES IN PRODUCTION, WITH ALL INSPECTIONS PERFORMED AND DEEMED ACCEPTABLE BY THE OPERATOR(S) AND QUALITY AS PER (B)(4). (NWV)

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT V3 RING UNIVERSAL (GREEN) 2 PACK BROKE DURING USE. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141149 V3 RING UNIVERSAL (GREEN) 2 PACK INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 06614879 D002659900V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown