BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONTEMPLATE ALIGNER ARCH

    MDR report key: 15275602 · Received August 23, 2022

    Report

    Report Number
    1649995-2022-00016
    Event Type
    Injury
    Date Received
    August 23, 2022
    Report Date
    September 8, 2022
    Manufacturer
    DENTSPLY SIRONA ORTHODONTICS INC.
    Product Code
    NXC
    PMA / PMN Number
    K171860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BECAUSE OF TOOTH UR3 TO BECOME INTRUDED INSTEAD OF EXTRUDED. THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. DEVICE WILL NOT BE RETURNED FOR EVALUATION AND LOT# NOT PROVIDED; RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FOUND. THERAPEUTIC MODEL 2, ACTUALLY IT IS A BIG IMPROVEMENT ON THE ALIGNMENT FOR UPPER AND LOWER ARCHES COMPARED WITH THE INITIAL SCAN. ALIGNERS WERE PACKAGED ON (B)(6) 2022, BY OF THIRD SHIFT BY BAG & BOX OPERATION. - WE REVIEWED THE DHR FOR THIS PATIENT AND FOUND NO EVIDENCE OF PROBLEMS OR DEVIATIONS DURING THE MANUFACTURING PROCESS IN THE ALIGNERS STAGE NUMBER UPPER 1. - WE REVIEWED THE DIGITAL STL FILE: SO-SR02407791-ARCH-001-012.STL AND IT DOES NOT CONTAIN ATTACHMENTS OR BOTTOM CUTS ON THE UR3 TOOTH AND WAS REQUESTED WITH A STRAIGHT TRIMMING LINE. THIS ALIGNER REQUIRED IN THE SALES ORDER WERE MANUFACTURED ACCORDING WITH DIGITAL FILES SPEC FROM SALES ORDER. NO DEFECT WAS FOUND DURING THE MANUFACTURING PROCESS. NO DEFECT PROVEN. NO FAILURE FOUND.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT WHILE USING NONTEMPLATE ALIGNER ARCH THE PATIENT EXPERIENCED AN UNFAVORABLE SHIFT IN THEIR TEETH RESULTING IN ANOTHER NEED TO REFINE TREATMENT. ROOT CAUSE OF THE UNINTENDED TOOTH MOVEMENT HAS BEEN IDENTIFIED AS LACK OF ATTACHMENTS AND TRIM LINE OF THE ALIGNERS (BOTH REQUESTED BY THE PATIENT AND THE DOCTOR), WHICH CAUSED TOOTH UR3 TO BECOME INTRUDED INSTEAD OF EXTRUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595931 NONTEMPLATE ALIGNER ARCH ALIGNER, SEQUENTIAL NXC DENTSPLY SIRONA ORTHODONTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown