{
  "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": "2026-09-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 228
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "I",
      "report_to_fda": "N",
      "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": "3006179046-2020-00317",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200528",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K180503",
      "date_of_event": "20200423",
      "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": [
        "COMPANY REPRESENTATIVE",
        "FOREIG"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "GM",
      "manufacturer_contact_area_code": "",
      "date_added": "20200528",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "558871",
          "implant_date_year": "2019",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200528",
          "brand_name": "PRECICE STRYDE SYSTEM",
          "generic_name": "ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES",
          "manufacturer_d_name": "NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED",
          "manufacturer_d_address_1": "101 ENTERPRISE",
          "manufacturer_d_address_2": "SUITE 100",
          "manufacturer_d_city": "ALISO VIEJO",
          "manufacturer_d_state": "CA",
          "manufacturer_d_zip_code": "92656",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "92656",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "PS10.0-50C235",
          "catalog_number": "",
          "lot_number": "9020514AA",
          "other_id_number": "",
          "device_availability": "No answer provided",
          "device_report_product_code": "HSB",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00887517950956",
          "udi_public": "887517950956",
          "openfda": {
            "device_name": "Rod, Fixation, Intramedullary And Accessories",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3020",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Defective Device",
        "Defective Device"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "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": "20200528",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "15 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Failure of Implant",
            "Failure of Implant"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200528",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10099772",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200429",
      "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": "193296870",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE ALLEGED EVENT. NO ROOT CAUSE CAN BE CONFIRMED AT THIS TIME."
        },
        {
          "mdr_text_key": "193296871",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "INFORMATION WAS RECEIVED THAT ON (B)(6) 2020 X-RAY IMAGES REVEALED THAT THE IMPLANT WAS BROKEN NAMELY IN THE PROXIMAL PORTION AT THE LEVEL OF ONE OF THE LOCKING SCREWS. THERE WAS NO PATIENT INJURY REPORTED."
        }
      ],
      "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": ""
    }
  ]
}