BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL CLEAR ALIGNERS

    MDR report key: 12833494 · Received November 17, 2021

    Report

    Report Number
    2081322-2021-00001
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    October 21, 2021
    Report Date
    November 17, 2021
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    NXC
    UDI-DI
    00190707089788
    PMA / PMN Number
    K162609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ORTHO ORGANIZERS, INC. RECEIVED A COMPLAINT ON (B)(6) 2021 FROM (B)(6) IN (B)(6), NV REGARDING A PATIENT WHO EXPERIENCED TOOTH FRACTURE DURING TREATMENT WITH THE REVEAL CLEAR ALIGNERS. ORTHO ORGANIZERS REQUESTED THE DEVICE FOR EVALUATION, BUT IT WAS NOT RECEIVED IN TIME FOR THIS REPORT. FOR THIS REASON, CONCLUSIONS ABOUT CAUSALITY ARE NOT ABLE TO BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED IF THE DEVICE IN QUESTION IS RETURNED.

    Description of Event or Problem · 0

    THE PATIENT ADVISED THE DOCTOR'S OFFICE THAT HER TEETH HAVE CHIPPED DURING TREATMENT WITH THE REVEAL CLEAR ALIGNERS. THE COMPLAINT AND SUPPORTING DOCUMENTATION STATE THAT THE (B)(6)-YEAR OLD PATIENT REPORTED TO THE DOCTOR'S OFFICE THAT HER LOWER TEETH HAD CHIPPED AFTER THE FIRST ALIGNER TRAY WAS SWITCHED. SHE REPORTED THAT UPPER TOOTH #8 CHIPPED ON INSIDE CORNER AND LOWER TOOTH # 25 CHIPPED ON TOP OF OCCLUSAL MARGIN DUE TO THE TOOTH MOVEMENT AFTER WEARING THE ALIGNERS FOR ONLY A FEW WEEKS. THE RETURNED QUESTIONNAIRE DID NOT INDICATE WHETHER THE PATIENT WORE THE ALIGNERS AT THE TIME. IN A LETTER SUBMITTED BY THE PATIENT, SHE DESCRIBED THAT - AFTER TWO WEEKS OF WEARING THE ALIGNERS - HER UPPER TEETH WOULD HIT HER LOWER TEETH WHEN SHE REMOVED THE ALIGNERS TO EAT. SHE WENT ON TO SAY THAT ONE WEEK LATER TWO OF HER TEETH HAD CHIPPED. WHILE THE PATIENT DID NOT SPECIFICALLY MENTION THIS, IT CAN BE REASONABLY ASSUMED THAT HER TEETH CHIPPED AFTER SHE REMOVED THE ALIGNERS AND WHILE SHE WAS EATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724006 REVEAL CLEAR ALIGNERS ALIGNER, SEQUENTIAL NXC ORTHO ORGANIZERS, INC. 570-1422 HD11745 00190707089788

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Disability