{ "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": 1 } }, "results": [ { "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": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2024-00037", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240327", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20240301", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20240327", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20221204", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "528209", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240327", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. 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THE ANALYSIS DETERMINED THAT THE PROBABLE CAUSE OF THE REPORTED DEVIATION WAS THE SKIVING OF SURGICAL TOOLS ON THE BONY ANATOMY AND THE SURGICAL TECHNIQUE EMPLOYED. 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": "338707392", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: EXPORTS HAVE BEEN RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. 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": "338707395", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text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} ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "1 HAESHEL STREET. (BUILDING C)", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "04/30/2024" } ] }