BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALODENT V3 UNIV 2 RING REFIL

    MDR report key: 20639125 · Received November 8, 2024

    Report

    Report Number
    2515379-2024-00052
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Report Date
    January 3, 2025
    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 RESULT: 12-30-2024: PRODUCT NOT RETURNED, IMAGE IN CASE DEPICTS 1 V3 UNIVERSAL RING (V5 VERSION) WITH THE OVERMOLDING ON ONE SIDE BROKEN OFF AS THE CUSTOMER DESCRIBES. OVERMOLDING DATE CODES COULD NOT BE VERIFIED WITH THE IMAGE ATTACHED (TOP VIEW AND NOT BOTTOM VIEW). RETURNED PRODUCT DOES NOT MEET SPECIFICATION, RETAINS WILL BE EVALUATED. (NWV). RETAINS: 12-30-2024: RETAINS FOR ITEM#: 659760V, LOT#: 08122108 ARE NOT AVAILABLE FOR REVIEW AS FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RETAINS FROM ITEM#: 759870 (V5 RING UNIVERSAL ¿ PALODENT) LOTS: 07975160 & 08151423 WERE PULLED AND REVIEWED AND INSPECTED PER 0290-IP-7.5-60-58 AND FUNCTIONALLY TESTED BY USING A PAIR OF FORCEPS OPENING COMPLETELY, LOCKING THE BAR, AND OBSERVED FOR TENSION AND RETURN TO MEMORY ONCE RELEASED FROM THE FORCEPS. ALL RETAIN SAMPLES WERE FOUND ACCEPTABLE TO SPECIFICATION AND MEET ALL FORM/FIT/FUNCTION REQUIREMENTS. (NWV). DHR: 12-30-2024: DHR FOR ITEM#: 659760V, LOT#: 08122108 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 REFILL. WORK ORDER: (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED V3 UNIVERSAL OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS ITEM#: 759870 (V5 RING UNIVERSAL ¿ PALODENT) LOT#: 08151423 (PRODUCED 03-2024) & LOT#: 07975160 (PRODUCED 02-2024). DHR FOR THIS MOLDING WORK ORDER 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 0290-WI-7.5-60-14 & 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 PALODENT V3 UNIV 2 RING REFIL BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044275 PALODENT V3 UNIV 2 RING REFIL INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 02122108 D002659760V1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown