BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIUS

    MDR report key: 14269183 · Received May 3, 2022

    Report

    Report Number
    3014680924-2022-00002
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    January 13, 2022
    Report Date
    April 29, 2022
    Manufacturer
    BRIUS
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INITIALLY NOTING THE EXTREME MOVEMENT IN UR2, BUT NOT UNDERSTANDING THE CAUSE, THE DOCTOR ORDERED A REPLACEMENT AS OPPOSED TO TAKING A NEW CT SCAN AND ORDERING A REFINEMENT;THE ORIGINAL DEVICE WAS REPLACED. IN A REPLACEMENT, AN IDENTICAL DEVICE IS MANUFACTURED USING THE SAME MOLD AS USED TO SHAPE FORM THE ORIGINAL DEVICE. AS THE TOOTH CONTINUED ITS UNUSUAL MOVEMENT, THE DOCTOR REMOVED THE REPLACEMENT DEVICE AND SUBMITTED A NEW CT SCAN AND ORDERED A REFINEMENT ON (B)(6) 2022. WHEN A REFINEMENT IS ORDERED, A NEW CT SCAN MUST BE SUBMITTED. A NEW MOLD MUST BE CREATED AS A REFINEMENT INDICATES A CHANGE IN THE TREATMENT PLAN. THEREFORE, NEW MOLDS WERE CREATED TO SHAPE FORM THE REFINEMENT DEVICE AND THE TOOTH MOVEMENT WAS CORRECTED. THE REFINEMENT WAS SHIPPED ON (B)(6) 2022. UPON RECEIPT OF THE REFINEMENT, THE DOCTOR RETURNED BOTH THE ORIGINAL AND REPLACEMENT DEVICES (524585.00BB, AND 524585.01BN) TO BRIUS FOR REVIEW ON (B)(6) 2022. AN INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICES. AFTER COMPARING THE INTENDED DESIGN OF THE BRIUS TO THE ACTUAL DEVICE, IT WAS NOTICED THAT THE POSITIONING OF THE ARM TO THE TOOTH IN QUESTION WAS DIFFERENT THAN INTENDED. AFTER EXAMINATION OF THE MOLD USED FOR SHAPE FORMING, IT WAS DETERMINED THAT THE MOLD HAD BEEN DAMAGED CAUSING THE ARM FOR UR2 TO HAVE A SLIGHT UNINTENDED BEND. THE UNINTENTIONAL BEND CAUSED SOME OF THE UNINTENDED MOVEMENT OF UR2, BUT THE PROBLEM WAS COMPOUNDED BY BRACKET POSITIONING ERROR WHEN THE BRACKET FOR UR2 WAS NOT BONDED TO THE PATIENT IN THE CORRECT INTENDED POSITION.THE PATIENT HAS RECEIVED A NEW DEVICE AND IS DOING WELL.

    Description of Event or Problem · 0

    TOOTH UPPER RIGHT 2 UR@ IS VERY MOBILE. PATIENT IS UNCOMFORTABLE AND AFRAID SHE MAY LOSE TOOTH. EVALUATED BRACKET POSITION AND DETERMINED ONE OF TWO THINGS CAUSING TOOTH TO BE TIPPED LINGUALLY AND SUPERERUPTED; 1- ISSUE WITH BRIUS DESIGN ITSELF (UR2 ARM IS SIGNIFICANTLY MORE LINGUAL AND INCISAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1218141 BRIUS BRIUS DZC BRIUS 100 524585.00BB;524585

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention