BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ VICTORY SERIES¿ BUCCAL TUBE

    MDR report key: 21152307 · Received January 14, 2025

    Report

    Report Number
    2020467-2025-00001
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    June 17, 2024
    Report Date
    January 14, 2025
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    DZD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED. A PHOTO OF THE BROKEN BUCCAL WAS REVIEWED; HOWEVER, CAUSE OF THE EVENT COULD NOT BE DETERMINED. SOLVENTUM WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CYLINDRICAL PART OF A 3M¿ VICTORY SERIES¿ BUCCAL TUBE CAME/BROKE OFF DURING SURGERY. IT REMAINED IN THE WOUND THAT WAS SUTURED. AN X-RAY REVEALED THAT A PIECE OF METAL WAS STILL INSIDE, AND A SECOND PROCEDURE WAS REQUIRED TO REMOVE. THE APPLIANCE TYPE USED IN THE HEADGEAR TUBE WAS NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987877 3M¿ VICTORY SERIES¿ BUCCAL TUBE TUBE, ORTHODONTIC DZD 3M UNITEK CORPORATION 068-914 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention