BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 10102574 · Received May 29, 2020

    Report

    Report Number
    2953749-2020-01305
    Event Type
    Injury
    Date Received
    May 29, 2020
    Date of Event
    May 1, 2020
    Report Date
    May 26, 2020
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K181739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THAT FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR AS THE PATIENT REPORTED A TOOTH EXTRACTION (PERMANENT IMPAIRMENT TO A BODY STRUCTURE) AND THE INVISALIGN PRODUCT WAS BEING USED,

    Description of Event or Problem · 1

    THE PATIENT REPORTED FRACTURING, PULPITIS, AND EXTRACTION OF TOOTH # 3 (UPPER RIGHT 1ST MOLAR), GINGIVAL INFLAMMATION, PAIN (OF THE HEAD, MANDIBLE, MAXILLA, TMJ), PAIN WITH COLD, HOT AND WHILE LYING DOWN. THE PATIENT REPORTED VISITING A DENTIST, WHO EXTRACTED TOOTH # 3. THE PATIENT REPORTED BEING PRESCRIBED KETOROLACO (ANTI-INFLAMMATORY) CELEBRA WITH SUPRACALM AND SOMNO (ANTI-INFLAMMATORY) TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2020 AND THE PATIENT IS CURRENTLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565218 INVISALIGN SYSTEM ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - COMPREHENSIVE 32941643

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability