BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOPS

    MDR report key: 12466334 · Received September 14, 2021

    Report

    Report Number
    3008846606-2021-00001
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    August 25, 2021
    Report Date
    September 14, 2021
    Product Code
    EKD
    UDI-DI
    00852673007028
    PMA / PMN Number
    K172164
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS A RESULT OF THE MALFUNCTION, SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE, THEREFORE THIS EVENT 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.

    Description of Event or Problem · 1

    THE TIP OF THE PERFORATION SCREW (MOPS) BROKE IN THE SOFT TISSUE DURING A ORTHODONTIC PROCEDURE. THE PATIENT WAS REFERRED TO AN ORAL SURGEON WHERE THE FRAGMENT WAS SURGICALLY REMOVED AND BONE GRAFTING WAS PERFORMED TO PREVENT POSSIBLE TOOTH LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368596 MOPS INSTRUMENT, CUTTING, OPERATIVE EKD NA 050321-00003 00852673007028

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention