BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V3 SUPERCURVE KIT

    MDR report key: 16565054 · Received March 17, 2023

    Report

    Report Number
    2515379-2023-00065
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Report Date
    April 14, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    DZN
    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, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR 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 RESULTS: 4-7-2023: RETURNED PRODUCT V3 RING NARROW YELLOW (NEW IMPROVED V5 RING) WITH BROKEN TYNE. OVERMOLDING ID ¿D¿ APRIL & ¿N¿ 2022. PRODUCT DOES NOT MEET SPECIFICATION, DHR REVIEW/RETAIN EVALUATION TO OCCUR. (NWV) DHR REVIEW: 4-7-2023: DHR FOR ITEM# 403316 LOT# 05623250 HAS BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEW DID NOT INDICATE ANY PRODUCTION ISSUES WHILE PACKAGING/LABELING THE V3 SUPERCURVE KIT. WORK ORDER (B)(4) IS THE PACKAGING WORK ORDER WHICH UTILIZED 2 DIFFERENT OVER-MOLDING OF THE SPRINGS TO RINGS PRODUCTION WORK ORDERS/RUNS IN WHICH ARE (B)(4) (PRODUCED 04-2022) & (B)(4) (PRODUCED 04-2022). DHRS FOR EACH OF THESE MOLDING WORK ORDERS HAVE ALSO BEEN PULLED, REVIEWED, AND ATTACHED TO THIS CASE. DHR REVIEWS DID INDICATE CONTAMINATION ISSUES IN PRODUCTION, HOWEVER THE OVERMOLDING PLASTIC IS REMOVED AND RE-OVERMOLDED AS PART OF NORMAL PROCESS. 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) 4-7-2023: FINAL PRODUCT RETAINS ARE NOT KEPT AS PER NORMAL PROCEDURE. RING OVER-MOLDING RETAINS FROM BATCHES (B)(4) WERE PULLED, REVIEWED, AND DEEMED ACCEPTABLE AS PER 0290-IP-7.5-60-58 AND MEET ALL FORM/FIT/FUNCTION. (NWV) ROOT CAUSE: NOT DETERMINED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A V3 SUPERCURVE BROKE DURING USE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939711 V3 SUPERCURVE KIT INSTRUMENTS, DENTAL HAND DZN DENTSPLY LLC 05623250

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown