{
  "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",
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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",
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      "manufacturer_contact_pcity": "76352656",
      "event_type": "Injury",
      "report_number": "3005075696-2026-00098",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "K182077",
      "date_of_event": "20241008",
      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "55112",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "7635265677",
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      "manufacturer_contact_l_name": "ELLIS",
      "source_type": [
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        "Company representation"
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "3079830",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
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      "date_added": "20260518",
      "manufacturer_contact_f_name": "JUSTIN",
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          "device_sequence_number": "651694",
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          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20260518",
          "brand_name": "MAZOR X SYSTEM",
          "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT",
          "manufacturer_d_name": "MAZOR ROBOTICS LTD",
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          "manufacturer_d_address_2": "CAESAREA BUSINESS PARK",
          "manufacturer_d_city": "CAESAREA HEFA,IL",
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          "device_availability": "No",
          "device_report_product_code": "OLO",
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          "combination_product_flag": "N",
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          "openfda": {
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260810",
      "health_professional": "Y",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "30",
      "manufacturer_contact_extension": "",
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          "date_received": "20260518",
          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
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          "patient_race": "",
          "patient_problems": [
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        }
      ],
      "distributor_city": "",
      "date_report": "20260518",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "IS",
      "manufacturer_contact_city": "MOUNDS VIEW",
      "mdr_report_key": "25210446",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260424",
      "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",
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      "mdr_text": [
        {
          "mdr_text_key": "401625832",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "A2-A4: PATIENT INFORMATION NOT AVAILABLE. D4, H4: SERIAL NUMBER UNAVAILABLE. H3, H6: NO PARTS WERE RETURNED FOR PRODUCT ANALYSIS. MULTIPLE PATIENT CODES WERE APPLIED BELOW CLARIFIES WHAT EACH IS ASSOCIATED WITH. E2330 - PAIN E2401 - PERMANENT INJURIES, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE 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": "401625833",
          "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 THE PATIENT HAD PERMANENT INJURIES, PAIN, SUFFERING, AND LOSS OF ENJOYMENT OF LIFE, AS A RESULT OF THE PROCEDURE."
        }
      ],
      "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": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}