{
  "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": "2016150-2020-00001",
      "type_of_report": [
        "Initial submission",
        "Followup"
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      "product_problem_flag": "N",
      "date_received": "20200522",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "reprocessed_and_reused_flag": "I",
      "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": [
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      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200522",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "547622",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20200522",
          "brand_name": "SPARK ADVANCED ALIGNERS",
          "generic_name": "SPARK ADVANCED ALGINERS",
          "manufacturer_d_name": "ORMCO CORPORATION",
          "manufacturer_d_address_1": "1937 W. MISSION BLVD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "POMONA, CA",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "I",
          "model_number": "728-3030",
          "catalog_number": "728-3030",
          "lot_number": "113997",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "NXC",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00889989083460",
          "udi_public": "00889989083460",
          "openfda": {
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Adverse Event Without Identified Device or Use Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/23/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250805",
      "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": "20200522",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Swelling",
            "Swelling"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200522",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10083283",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200423",
      "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": "319036203",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT BY EMAIL ON (B)(6) 2020, (B)(6) 2020, AND (B)(6) 2020 IN ORDER TO OBTAIN FURTHER INFORMATION ON THE WELL BEING OF THE PATIENT; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO SUGGEST THAT A SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT."
        },
        {
          "mdr_text_key": "194840133",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IT WAS ALLEGED THAT A PATIENT HAD A REACTION TO THE PRODUCT SPARK ADVANCED ALIGNERS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED IF THE PATIENT HAS FULLY RECOVERED. A FOLLOW UP WILL BE DONE ONCE ADDITIONAL INFORMATION IS GIVEN."
        },
        {
          "mdr_text_key": "194840134",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE PATIENT HAS AN ANGIOEDEMA DIAGNOSIS AND HAS SWELLING IN HER MOUTH WHEN WEARING THE SPARK 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": "09/14/2020"
    }
  ]
}