BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMYLIO CLEAR ALIGNERS

    MDR report key: 14255453 · Received April 29, 2022

    Report

    Report Number
    3015143007-2022-00001
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    April 8, 2022
    Report Date
    April 29, 2022
    Manufacturer
    SMYLIO
    Product Code
    NXC
    PMA / PMN Number
    K173784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT PURCHASED ALIGNER TREATMENT ON (B)(6) 2019. THE PATIENT'S ALIGNERS WERE DELIVERED ON (B)(6) 2019, WHICH INDICATES THE DATE THE PATIENT BEGAN TREATMENT. ON (B)(6) 2020 A NEW TREATMENT PLAN WAS CREATED FOR THE PATIENT, INDICATING A SWITCH OF TREATING PHYSICIANS FROM DR. (B)(6) TO DR. (B)(6). UPON THIS SWITCH, DR. (B)(6) RECOMMENDED THE PATIENT RECEIVE TREATMENT ON BOTH UPPER AND LOWER ARCHES WHEREAS, THE PATIENT HAD INITIALLY BEEN RECEIVING TREATMENT ONLY ON THE UPPER ARCH. THE PATIENT REACHED OUT TO ORTHOFX ON (B)(6) 2021 AND THE PATIENTS INQUIRE WAS ESTABLISHED AS A COMPLAINT CASE ON (B)(6) 2021. THE INITIAL COMPLAINT THAT THE CUSTOMER SUCCESS TEAM RECEIVED STATES, "THE PATIENT HAS BEEN ON TREATMENT FOR A FEW YEARS ALREADY HOWEVER SHE HAS NOT GOTTEN THE RESULTS SHE WANTS. SHE STARTED TREATMENT WITH DR. (B)(6). HOWEVER, THE DOCTOR LEFT THE OFFICE. SHE IS CONCERNED ABOUT HER CASE NOT BEING HANDLED PROPERLY (CLINICALLY)". SINCE THE DATE OF THE INITIAL COMPLAINT, THE ORTHOFX CUSTOMER SUCCESS TEAM WORKED WITH THE PATIENT TO RESOLVE THE ISSUE BY REACHING OUT TO THE REGIONAL MANAGER FOR ASSISTANCE IN FINDING THE PATIENT A NEW PROVIDER TO TREAT THE PATIENT'S CASE WHICH WAS ASSIGNED TO DR. (B)(6). THE PATIENT HAD AN APPOINTMENT WITH DR. (B)(6) ON (B)(6) 2022. ON (B)(6) 2022 REACHED OUT TO ORTHOFX WITH INFORMATION CONCERNING HER APPOINTMENT WITH DR. (B)(6). THE PATIENT STATED THAT DR. (B)(6) RECOMMENDED THAT THE PATIENT RECEIVE MYOFASCIAL THERAPY TO MITIGATE ISSUES CAUSED BY TREATMENT RECEIVED BY DR. (B)(6). THE ORTHOFX REGIONAL MANAGER REACHED OUT TO DR. (B)(6) ON (B)(6) 2022 TO CONFIRM TREATMENT HE WAS RECOMMENDING FOR PATIENT. DR. (B)(6) FOLLOWED UP BY STATING "SHE HAS A MOLAR OPEN BITE, GENERALIZED BONE LOSS, MODERATE TO SEVERE RECESSION. TOOTH MOBILITY. I RECOMMENDED TO HER TO SEE A PERIODONTIST BEFORE ANY FURTHER TREATMENT. SHE DID REFUSE UNTIL RECENTLY TO TAKE ANY X-RAYS." AFTER RECEIVING THIS INFORMATION FROM DR. (B)(6), THE ORTHOFX TEAM CONCLUDED THAT THIS WAS A REPORTABLE EVENT ON (B)(6) 2022. THE PATIENT REFUSES TO RETURN THE PRODUCT. THE PATIENT IS UNDER CARE BY ANOTHER DR AT THIS TIME AND TREATMENT WITH THE ALIGNER HAS BEEN STOPPED. THERE IS NO FURTHER COMMENTARY FROM THE PATIENT. INVESTIGATION OF PRODUCT INCLUDED LOT/PRODUCTION RECORDS, RISK ANALYSIS, CONVERSATIONS WITH CARE TEAM (DRS) INVOLVED AND CONVERSATIONS WITH THE PATIENT. THE INVESTIGATION SHOWED NO DEVICE FAILURE OR ISSUES THAT CAN BE ATTRIBUTED TO THE DEVICE ITSELF.

    Description of Event or Problem · 0

    THE PATIENT HAD A VISIT WITH THEIR DOCTOR WHO RECOMMENDED THE PATIENT SEE A PERIODONTIST BEFORE TREATMENT DUE TO THE PATIENT'S OPEN BITE, GENERALIZED BONE LOSS AND MODERATE TO SEVERE RECESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144216 SMYLIO CLEAR ALIGNERS ALIGNERS NXC SMYLIO 101159W

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention