BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 12567769 · Received October 4, 2021

    Report

    Report Number
    12567769
    Event Type
    Malfunction
    Date Received
    October 4, 2021
    Date of Event
    August 31, 2021
    Report Date
    September 21, 2021
    Manufacturer
    BIOMET MICROFIXATION, INC
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR DENTAL EXTRACTION PROCEDURE FOR THE PATIENT. FOLLOWING EXTRACTION OF TEETH #1,16,32 IT WAS NOTED THAT THE SMALL STRAIGHT ELEVATOR WAS CHIPPED AT THE WORKING END, ABOUT 1MM IN SIZE, WAS MISSING. THE SURGICAL SITES WERE IRRIGATED WELL, SUCTIONED, AND EXPLORED. THERE WAS NO POINT IN THE CASE WHERE FORCE WAS APPLIED TO THE INSTRUMENT SUCH THAT IT WOULD CREATE A CHIP IN THE INSTRUMENT OR ANY POINT WHEN IT WAS HEARD/FELT TO CHIP. LIKELY THE INSTRUMENT CAME THAT WAY FROM SPD AND A SAFETY POST WILL BE COMPLETED REGARDLESS. DUE TO SMALL SIZE, LESS THAN 2MM, NO X RAY WAS TAKEN, AND THIS WAS DISCUSSED AMONG THE OR TEAM AND AGREED UPON. DISCUSSED WITH PATIENT FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1465945 N/A ELEVATOR, SURGICAL, DENTAL EMJ BIOMET MICROFIXATION, INC 09-0257

    Patients

    Seq Age Sex Outcome Treatment
    1 5840 DA