{ "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": "3005075696-2024-00058", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240516", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20240126", "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": "20240516", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20220119", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "618234", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240516", "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 ROOT CAUSE OF THE INACCURACY REPORTED IN THE OPERATING ROOM IS SOFT-TISSUE PRESSURE APPLIED ON THE TOOLS WHILE INSTRUMENTING, RESULTING IN MEDIALLY DEVIATED LEFT TRAJECTORIES. 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": "342705861", "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 SURGEON CAUSED A TEAR OF THE SPINAL MEMBRANE(DUROTOMY) DUE TO DEVIATED PLACEMENT OF THE LEFT PEDICLE SCREW. THE SURGEON FELT THE CAUSE OF THE DEVIATED SCREW PLACEMENT WAS DUE TO A MALFUNCTION WITH THE GUIDANCE SYSTEM. THE PATIENT'S SPINAL CORD MEMBRANE WAS TORN APART, RESULTING IN SIGNIFICANT PERMANENT INJURIES INCLUDING EPIDURAL HEMATOMA, INTRADURAL COMPRESSIVE FLUID COLLECTION,  SEVERED LUMBAR NERVE ROOTS,  LOSS OF USE OF LIMBS, FOOT DROP, INCONTINENCE, AND OTHER INJURIES CONSISTENT WITH CAUDA EQUINA SYNDROME. THE PATIENT HAS ALSO EXPERIENCED PAIN AND MENTAL ANGUISH." }, { "mdr_text_key": "342705862", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2-A4: PATIENT INFORMATION IS UNAVAILABLE. H3, H6: NO PARTS HAVE BEEN RETURNED FOR PRODUCT ANALYSIS. THERE ARE MULTIPLE PATIENT CODES PROVIDED. BELOW IS WHAT EACH IS ASSOCIATED WITH: E2015 - TEAR OF THE SPINAL MEMBRANE. E0106 - INTRADURAL COMPRESSIVE FLUID COLLECTION. E0123, E0139 - SEVERED LUMBAR NERVE ROOTS E0202 - MENTAL ANGUISH E0505 - EPIDURAL HEMATOMA E2302 - LOSS OF USE OF LIMBS. E2330 - PAIN E2401 - INCONTINENCE, CAUDA EQUINA SYNDROME. 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": "387362726", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SEE B5. D4: UDI UPDATED. 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": "387362727", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE SURGEON SPECIFIED THAT THEIR SUSPECTED CAUSE WAS THAT THERE WAS A MISMATCH BETWEEN THE TRUE LOCATION OF THE PEDICLE SCREW AND THE LOCATION DISPLAYED ON THE DEVICE¿S SCREEN. THE GUIDANCE SYSTEM ALSO GENERATED WARNINGS CONCERNING THE SCREW ANGLES EXCEEDING 12 DEGREES RELATIVE TO THE MIDLINE, AS THIS INCREASES THE RISK OF SOFT TISSUE PRESSURE AND SCREW MISPLACEMENT. DESPITE THIS, THE SURGEON CONTINUED PLACEMENT AT GREATER THAT 12 DEGREES." } ], "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": "12/06/2024;09/30/2025" } ] }