BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANI SURGICAL BURS

    MDR report key: 18919461 · Received March 18, 2024

    Report

    Report Number
    3002692886-2024-00001
    Event Type
    Injury
    Date Received
    March 18, 2024
    Report Date
    March 15, 2024
    Manufacturer
    MANI HANOI CO., LTD.
    Product Code
    EJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION, HOWEVER, THE LOT NUMBER WAS PROVIDED AND ONE BUR OF THE SAME LOT HAS BEEN RETURNED. AS A RESULT OF THE INVESTIGATION, THE RETURNED PRODUCT( FROM SAME LOT RETURNED FROM USER) WERE CONFIRMED TO BE MANI PRODUCTS, THE APPEARANCE AND DIMENSIONS, AS WELL AS THE RESULTS OF MACHINABILITY TEST, WERE ALL WITHIN THE STANDARD VALUES, ALSO NO PROBLEMS WERE IDENTIFIED DURING THE REPRODUCIBILITY OF PROPERLY OPERATION. WE ANALYZED THAT THERE IS A LARGE POSSIBILITY THAT OUR DEVICES WERE USED IN A WAY THAT WAS NOT INTENDED, AND WE WILL RECOMMEND THE MODEL #MZB TO USERS FOR REMOVAL OF AN IMPACTED TOOTH. A SUPPLEMENTAL REPORT WOULD BE FOLLOWED UP FROM US ONLY IF ADDITIONAL INFORMATION REGARDING THE PATIENT BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT THREE OF THE FOUR USED CARBIDE BURS BROKE DURING EXTRACTION OF THE LEFT MANDIBULAR THIRD MOLAR, AN X-RAY WAS TAKEN AT CLINIC AND A BROKEN PART PENETRATED INTO JAW WAS FOUND. HOWEVER THE BROKEN PIECE CANNOT BE REMOVED AT PAIR MALL DENTAL CLINIC. ACCORDING TO THE PATIENT, HE DIDN'T FEEL PAIN AND NUMBNESS. CONTINUED FOLLOW-UP WILL BE PERFORMED AT PAIR MALL DENTAL CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178762 MANI SURGICAL BURS DENTAL BURS EJL MANI HANOI CO., LTD. 25MM #330 C22A015100

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male Other| R