{
  "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": "2026-07-28",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "TN",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "MEMPHIS",
      "manufacturer_contact_address_1": "1800 PYRAMID PLACE",
      "manufacturer_contact_pcity": "76352656",
      "event_type": "Malfunction",
      "report_number": "3003120897-2026-01105",
      "type_of_report": [
        "Initial submission"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260630",
      "manufacturer_address_2": "",
      "pma_pmn_number": "EXEMPT",
      "date_of_event": "20260602",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "38132",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "7635265677",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "ELLIS",
      "source_type": [
        "User facility"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "38118",
      "manufacturer_g1_state": "TN",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "763",
      "date_added": "20260630",
      "manufacturer_contact_f_name": "JUSTIN",
      "device_date_of_manufacturer": "20130102",
      "previous_use_code": "R",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "316826",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260630",
          "brand_name": "CD HORIZON SOLERA 5.5/6.0",
          "generic_name": "SCREWDRIVER",
          "manufacturer_d_name": "MEDTRONIC SOFAMOR DANEK USA, INC.",
          "manufacturer_d_address_1": "4340 SWINEA RD",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MEMPHIS",
          "manufacturer_d_state": "TN",
          "manufacturer_d_zip_code": "38118",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "38118",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "5584111",
          "catalog_number": "5584111",
          "lot_number": "RS12K033",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20260623",
          "device_report_product_code": "HXX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "00643169043640",
          "udi_public": "(01)00643169043640(11)130102(10)RS12K033",
          "openfda": {
            "device_name": "Screwdriver",
            "medical_specialty_description": "Orthopedic",
            "regulation_number": "888.4540",
            "device_class": "1"
          }
        }
      ],
      "product_problems": [
        "Break"
      ],
      "reporter_state_code": "KS",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260701",
      "health_professional": "",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "7635",
      "patient": [
        {
          "patient_sequence_number": "1",
          "date_received": "20260630",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260630",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "MEMPHIS",
      "mdr_report_key": "25662221",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260602",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "38118",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MEDTRONIC SOFAMOR DANEK USA, INC.",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "407357584",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "PRODUCT ANALYSIS OF PRODUCT: (B)(4)., LOT: RS12K033 VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT THE TIP OF THE DRIVER WAS WORN. THE DAMAGE IS CONSISTENT WITH ANTICIPATED WEAR OVER TIME. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN."
        },
        {
          "mdr_text_key": "407357585",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR TRANSFORAMINAL LUMBAR INTE RBODY FUSION. IT WAS REPORTED THAT THE DRIVERS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "4340 SWINEA RD",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "38132",
      "manufacturer_contact_exchange": "763",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
  ]
}