BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMILEDIRECTCLUB RETAINE

    MDR report key: 12762496 · Received November 7, 2021

    Report

    Report Number
    3014658399-2021-01293
    Event Type
    Injury
    Date Received
    November 7, 2021
    Date of Event
    May 30, 2020
    Report Date
    November 5, 2021
    Manufacturer
    ACCESS DENTAL LAB
    Product Code
    KMY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED BY THE PATIENT, THERE IS NO CONCLUSIVE EVIDENCE THAT SUPPORTS OR OPPOSES THE FACT THAT THE RETAINER CAUSED, CONTRIBUTED, OR WOULD LIKELY CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED SYMPTOMS OR PHYSIOLOGICAL CONDITIONS THAT DESCRIBE TOOTH (BREAKAGE) FRACTURE. AS PER CAPA #(B)(4) THIS EVENT IS RETROSPECTIVELY BEING REPORTED AND THEREFORE WAS NOT REPORTED WITHIN THE REQUIRED 30-DAYS.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A BROKEN TOOTH WHILE WEARING THE RETAINER, THE CUSTOMER WAS NOT ABLE TO PROVIDE THE IMPACTED TOOTH NUMBER. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. IT IS UNKNOWN IF ALIGNER TREATMENT WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661690 SMILEDIRECTCLUB RETAINE RETAINER KMY ACCESS DENTAL LAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Unknown Other