{
  "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": "2026-08-05",
    "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": "Malfunction",
      "report_number": "3004893332-2020-00003",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200429",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K102995",
      "date_of_event": "20200409",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "",
      "source_type": [
        "HEALTH PROFESSIONAL",
        "USER FACI"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20200429",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "475648",
          "implant_date_year": "2010",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200429",
          "brand_name": "TALON",
          "generic_name": "ORTHOSIS, SPINAL PEDICLE FIXATION",
          "manufacturer_d_name": "SPINAL ELEMENTS, INC",
          "manufacturer_d_address_1": "3115 MELROSE DRIVE, SUITE 200",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "CARLSBAD, CA",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "MNI",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthosis, Spinal Pedicle Fixation",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3070",
            "device_class": "2",
            "registration_number": [
              "3004893332"
            ],
            "fei_number": [
              "3004893332"
            ]
          }
        }
      ],
      "product_problems": [
        "Mechanical Problem",
        "Mechanical Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250825",
      "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": "20200429",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "62 YR",
          "patient_sex": "",
          "patient_weight": "99",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Failure of Implant",
            "Failure of Implant"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200409",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10012135",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200409",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "200481125",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "NO CLARIFYING DETAILS WERE PROVIDED. NO FURTHER INFORMATION WAS ABLE TO BE RECEIVED. MANUFACTURER COULD NOT BE DETERMINED. THE ROOT CAUSE IS UNKNOWN, BUT POSSIBLE PSEUDARTHROSIS CAN BE A FACTOR WITH A TEN YEAR IMPLANT DURATION."
        },
        {
          "mdr_text_key": "200481126",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "RECEIVED INQUIRY TO DETERMINE UNKNOWN MANUFACTURER OF FRACTURED S1 BONE SCREWS THAT WAS IMPLANTED TEN YEARS PRIOR. REVISION SURGEON IS DIFFERENT THAN THE ORIGINAL SURGEON. NO MEDICAL RECORDS IDENTIFYING IMPLANT MANUFACTURER WERE PROVIDED AND RADIOGRAPHS ARE INCONCLUSIVE IN DETERMINING THE MANUFACTURER. REVISION SURGERY IS SPECULATED, HOWEVER NOT CONFIRMED. NO FURTHER DETAILS ABOUT THE EVENT OR THE PATIENT CONDITION WERE PROVIDED."
        }
      ],
      "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": ""
    }
  ]
}