{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-18",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
      "event_type": "Injury",
      "report_number": "2953749-2020-01261",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "N",
      "date_received": "20200512",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K181739",
      "date_of_event": "20200401",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "DENTIST",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "HEALTH PROFESSIONAL"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200512",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "511195",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200512",
          "brand_name": "INVISALIGN SYSTEM",
          "generic_name": "ALIGNER, SEQUENTIAL",
          "manufacturer_d_name": "ALIGN TECHNOLOGY, INC.",
          "manufacturer_d_address_1": "2820 ORCHARD PARKWAY",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SAN JOSE, CA",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "LAY USER/PATIENT",
          "model_number": "INVISALIGN SYSTEM - COMPREHENSIVE",
          "catalog_number": "8824",
          "lot_number": "33968346",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "NXC",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "2953749"
            ],
            "fei_number": [
              "3002519584"
            ],
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Appropriate Device Problem Term/Code Not Available",
        "Appropriate Device Problem Term/Code Not Available"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250812",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20200512",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Disability"
          ],
          "patient_age": "33 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200506",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10049482",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200421",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "190979741",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "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 LOST A TOOTH WHILE AN INVISALIGN PRODUCT WAS BEING USED."
        },
        {
          "mdr_text_key": "190979742",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE PATIENT REPORTED HAVING TEETH EXTRACTED (UNSPECIFIED TEETH). IT IS UNKNOWN IF THE PATIENT REQUIRED ANY MEDICAL INTERVENTION TO ALLEVIATE THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE PATIENT TOOK OR WAS PRESCRIBED ANY MEDICATION DUE TO THE REPORTED SYMPTOM. IT IS UNKNOWN IF THE TREATMENT WAS DISCONTINUED OR IF THE PATIENT IS STILL WEARING THE ALIGNERS."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}