{
  "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": {
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    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "NO INFORMATION",
      "report_to_fda": "I",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
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      "manufacturer_g1_city": "",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "report_number": "MW5095374",
      "type_of_report": [
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      "product_problem_flag": "N",
      "date_received": "20200702",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20200629",
      "reprocessed_and_reused_flag": "I",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PATIENT",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200706",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "686585",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200702",
          "brand_name": "BYTE ALIGNERS",
          "generic_name": "ALIGNER, SEQUENTIAL",
          "manufacturer_d_name": "BYTE INVISIBLE BRACES",
          "manufacturer_d_address_1": "12100 WILSHIRE BLVD,",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "LOS ANGELES",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "90025",
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          "manufacturer_d_country": "US",
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          "device_operator": "I",
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          "lot_number": "",
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          "device_availability": "No answer provided",
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          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Aligner, Sequential",
            "medical_specialty_description": "Dental",
            "regulation_number": "872.5470",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Unexpected Therapeutic Results"
      ],
      "reporter_state_code": "MA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250810",
      "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": "20200702",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "23 YR",
          "patient_sex": "",
          "patient_weight": "60",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Sensitivity of Teeth",
            "No Code Available",
            "Sensitivity of Teeth",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200702",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10233221",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Voluntary 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": "197820920",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "PT REPORTED SHE USED THE BYTE ALIGNER FOR 8 WEEKS. ON (B)(6) 2020, AFTER WEARING THE ALIGNERS OVERNIGHT, SHE WOKE UP WITH HER FRONT TOP TOOTH DISCOLORED. SHE DESCRIBED IT AS A DARK GRAY BLUE COLOR. SHE WENT TO HER DENTIST FOR AN EMERGENCY APPOINTMENT. SHE STATED THAT HER DENTIST INFORMED HER THAT THE TOOTH SHIFTED TOO QUICKLY AND CAUSED BLOOD TO GO INTO HER TOOTH. HE INSTRUCTED HER TO STOP USING THE ALIGNER IMMEDIATELY. SHE WAS TOLD TO TAKE 12 ADVIL A DAY FOR 6 TO 8 WEEKS AND SEE IF THE BLOOD WILL DRAIN ON ITS OWN. IF NOT SHE WILL HAVE TO HAVE ROOT CANAL THERAPY TO SAVE HER TOOTH. SHE IS VERY UPSET AND HAS ATTEMPTED TO CONTACT THE (B)(6) DENTAL ASSOCIATION AS INSTRUCTED BY HER DENTIST. SHE HOPES THAT BYTE WILL STOP PAYMENTS."
        }
      ],
      "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": ""
    }
  ]
}