{
  "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": {
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      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "CAESAREA BUSINESS PARK",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "MN",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "8200 CORAL SEA STREET NE MVS21",
      "manufacturer_g1_city": "CAESAREA HEFA,IL",
      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "76352656",
      "event_type": "Injury",
      "report_number": "3005075696-2025-00252",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K203005",
      "date_of_event": "20250403",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "55112",
      "reporter_occupation_code": "003",
      "manufacturer_contact_plocal": "7635265677",
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      "manufacturer_contact_l_name": "ELLIS",
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        "Health Professional",
        "Company representation"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "3079830",
      "manufacturer_g1_state": "",
      "reporter_country_code": "JA",
      "manufacturer_contact_area_code": "763",
      "date_added": "20250421",
      "manufacturer_contact_f_name": "JUSTIN",
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          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "1164485",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20250421",
          "brand_name": "MAZOR X SYSTEM",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
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          "manufacturer_d_address_2": "CAESAREA BUSINESS PARK",
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          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "OLO",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
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          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Orthopedic Stereotaxic Instrument",
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        "Adverse Event Without Identified Device or Use Problem"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20250725",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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          "date_received": "20250421",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            "Other"
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Ambulation or Postural Difficulties",
            "Insufficient Information",
            "Back pain",
            "Ambulation or Postural Difficulties",
            "Insufficient Information",
            "Back pain"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20250421",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "IS",
      "manufacturer_contact_city": "MOUNDS VIEW",
      "mdr_report_key": "21875415",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20250403",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "30798",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MAZOR ROBOTICS LTD",
      "adverse_event_flag": "Y",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "N",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "368565625",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "A1-A4: PATIENT INFORMATION IS UNAVAILABLE DUE TO RESTRICTION BY THE REGION'S PRIVACY REGULATION. H3, H6: NO PARTS WERE RETURNED FOR PRODUCT ANALYSIS. MULTIPLE PATIENT CODES WERE APPLIED. BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. E1651 - BACK PAIN E2302 - GAIT DISTURBANCE E2401 - FORWARD LEANING OF THE TRUNK HEARTBURN. 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": "368565626",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS A MEDIAL PUNCTURE ON THE RIGHT VERTEBRAE LEVEL. THE PATIENT NOW SUFFERS FOR LOWER BACK PAIN, FORWARD LEANING OF THE TRUNK, GAIT DISTURBANCE, AND HEARTBURN. THE PROCEDURE WAS COMPLETED WITH A NAVIGATION AND IMAGING SYSTEM. THERE WAS NO DELAY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THERE WAS NO DEVIATION WITH THE TRAJECTORIES."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "55112",
      "manufacturer_contact_exchange": "763",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}