{
  "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,
      "total": 14567
    }
  },
  "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": "1030489-2020-00479",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20200427",
      "manufacturer_address_2": "",
      "pma_pmn_number": "K032265",
      "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": "KS",
      "manufacturer_contact_area_code": "",
      "date_added": "20200427",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "464519",
          "implant_date_year": "2019",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200427",
          "brand_name": "CD HORIZON SPINAL SYSTEM",
          "generic_name": "APPLIANCE, FIXATION, SPINAL INTERLAMINAL",
          "manufacturer_d_name": "MDT SOFAMOR DANEK PUERTO RICO MFG",
          "manufacturer_d_address_1": "BARRIO MARIANNA RD 909, KM0.4",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "HUMACAO",
          "manufacturer_d_state": "PR",
          "manufacturer_d_zip_code": "00792",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "00792",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "NA",
          "catalog_number": "7576545",
          "lot_number": "H5567246",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "KWP",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "00885074031156",
          "udi_public": "00885074031156",
          "openfda": {
            "registration_number": [
              "1030489"
            ],
            "fei_number": [
              "1000477302"
            ],
            "device_name": "Appliance, Fixation, Spinal Interlaminal",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.3050",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Break",
        "Break"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250730",
      "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": "20200427",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Required Intervention"
          ],
          "patient_age": "21 YR",
          "patient_sex": "",
          "patient_weight": "55",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Known Impact Or Consequence To Patient",
            "No Known Impact Or Consequence To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10001327",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200403",
      "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": "189243105",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. X-RAY REVIEW RESULTS: POST-OP X-RAYS FROM L4-L5 TLIF WERE PROVIDED. AN INTERBODY GRAFT IS PRESENT. BY REPORT, THERE IS A SEPARATION OF THE SCREW HEAD FROM THE SHANK. IT IS NOT APPRECIABLE ON THESE IMAGES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "189243106",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BACK PAIN; AND UNDERWENT POSTERIOR LUMBAR INTERBODY FUSION AT L4-L5. ON AN UNKNOWN DATE, POST-OP, THE HEAD AND THE BODY OF THE SCREW GOT SEPARATED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE BROKEN SCREW WAS COMPLETELY EXPLANTED."
        }
      ],
      "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": ""
    }
  ]
}