{ "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": "8200 Coral Sea Street NE MVS21", "manufacturer_g1_city": "Caesarea Hefa,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "+1(763)5", "event_type": "Injury", "report_number": "3005075696-2026-00127", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260813", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20260715", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "+1(763)526-5677", "noe_summarized": "1", "manufacturer_contact_l_name": "Ellis", "source_type": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "PR", "manufacturer_contact_area_code": "", "date_added": "20260813", "manufacturer_contact_f_name": "Justin", "device_date_of_manufacturer": "20250310", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "117340", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260813", "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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No failure was found. Codes B01, C19, and D14 are applicable to this analysis. 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": "15464525549", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "Medtronic received information regarding a guidance system being used outside of a procedure. It was reported that the client reported an issue with a screw. It was reported that this issue occurred intra op of a Transforaminal Lumbar Interbody Fusion (TLIF) L4-L5. The pedicle screws were planned correctly during the planification stage, but after reviewing the last images taken, the screws in L4-L5 Left side appeared to be shifted medially. The pedicles of the patient were small but still the Surgeon decided to place 7.5 in diameter screws. There was no delay to the procedure. The patient experienced pain/discomfort and could not move his left foot with the entire range of motion. The next day of the procedure, Surgeon removed both left side screws from the patient. Additional information was received. It was reported that the screw was deviated less than 3.5 millimeters (mm). The patient continued to have left foot weakness after the additional procedure and removal of the hardware. No additional procedures resolved the patient's pain. The patient's pedicles measured 8.5mm during planning." } ], "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": "" } ] }