BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVERA RETAINER

    MDR report key: 15621074 · Received October 18, 2022

    Report

    Report Number
    2953749-2022-03261
    Event Type
    Injury
    Date Received
    October 18, 2022
    Date of Event
    September 1, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    DYT
    UDI-DI
    00816063020028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS MADE BASED ON INFORMATION RECIEVED FROM THE PATIENT. ALIGN TECHNOLOGY, INC. DID NOT CONTACT THE TREATING DOCTOR UPON THE PATIENT'S REQUEST. THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING: "GENERAL RISKS TO PATIENTS - EXISTING DENTAL RESTORATIONS (E.G: CROWNS, BRIDGES) MAY BECOME DISLODGED AND REQUIRE RE-CEMENTATION OR, IN SOME INSTANCES, REPLACEMENT," "A TOOTH THAT HAS BEEN PREVIOUSLY TRAUMATIZED OR SIGNIFICANTLY RESTORED MAY BE AGGRAVATED. IN RARE INSTANCES, THE USEFUL LIFE OF THE TOOTH MAY BE REDUCED, THE TOOTH MAY REQUIRE ADDITIONAL DENTAL TREATMENT SUCH AS ENDODONTIC AND/OR ADDITIONAL RESTORATIVE WORK, AND/OR THE TOOTH MAY BE LOST," "THE HEALTH OF THE BONE AND GUMS WHICH SUPPORT THE TEETH MAY BE IMPAIRED AND AGGRAVATED." THE POTENTIAL ROOT CAUSE IS UNKNOWN. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE VIVERA RETAINERS CAUSED THE REPORTED SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR AS THE PATIENT REPORTED TOOTH LOSS (SERIOUS INJURY) AND THE VIVERA RETAINERS WERE BEING USED.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SYMPTOMS OF PAIN ON TEETH, SOFT TISSUE RECESSION AND EXTRACTION OF TOOTH #29. IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION. IT IS UNKNOWN IF THE PATIENT IS CONTINUING THE USE OF THE RETAINERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342228 VIVERA RETAINER MAINTAINER, SPACE PREFORMED, ORTHODONTIC DYT ALIGN TECHNOLOGY, INC. VIVERA RETAINER 122997451 00816063020028

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Disability