{ "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": "76352656", "event_type": "Injury", "report_number": "3005075696-2025-00427", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20251223", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20250417", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Study", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20251223", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20190418", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1590935", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251223", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "1 HAESHEL STREET. (BUILDING C)", "manufacturer_d_address_2": "CAESAREA BUSINESS PARK", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30798", "manufacturer_d_zip_code_ext": "30", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079830", "device_operator": "HEALTH PROFESSIONAL", "model_number": "TPL0059", "catalog_number": "TPL0059", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "(01)07290109183213(11)190418", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260223", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "7635", "patient": [ { "patient_sequence_number": "1", "date_received": "20251223", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Hospitalization" ], "patient_age": "42 YR", "patient_sex": "Female", "patient_weight": "70 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Muscle Weakness/Atrophy", "Pain", "Paresthesia", "Unspecified Nervous System Problem", "Muscle Weakness/Atrophy", "Pain", "Paresthesia", "Unspecified Nervous System Problem" ] } ], "distributor_city": "", "date_report": "20251223", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23878702", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20251205", "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": "388384974", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6) NO PARTS HAVE RETURNED TO THE MANUFACTURER FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. H6) MULTIPLE ANNEX E CODES WERE APPLIED TO CAPTURE PATIENT IMPACT. SEE BELOW FOR CLARIFICATIONS. E013403 - PARESTHESIA E1621 - WEAKNESS E2330 - PAIN E0139 - FOOT DROP. 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": "388384975", "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 FOLLOWING A SPINAL SURGERY, THE PATIENT WAS INITIALLY DOING WELL, BUT LATER DEVELOPED PROGRESSIVELY WORSENING LOW BACK PAIN (LEFT GREATER THAN RIGHT) AND LEFT LOWER-EXTREMITY PAIN OVER SEVERAL MONTHS. SYMPTOMS INCLUDED PAIN, PARESTHESIA'S, WEAKNESS, AND OCCASIONAL SENSATION OF LEFT-SIDED FOOT DROP; NO BOWEL OR BLADDER INCONTINENCE WAS REPORTED. PAIN WAS CONSTANT TO SOME DEGREE AND WORSENED WITH PROLONGED POSITIONING, RESEMBLING SYMPTOMS PRIOR TO THE PATENT'S ORIGINAL BERTOLOTTI'S FUSION. IT WAS SUGGESTED THAT MICROMOTION AT THE LEFT BERTOLOTTI'S JOINT POSSIBLY CONTRIBUTED TO SYMPTOMS, WITH RESIDUAL HARDWARE ALSO CONSIDERED AS A POTENTIAL FACTOR. THE PATIENT UNDERWENT A LEFT-SIDED BERTOLOTTI JOINT RESECTION AND REMOVAL OF RIGHT-SIDED INSTRUMENTATION AT L6/S1.POST-OPERATIVELY, LOW BACK AND LOWER EXTREMITY SYMPTOMS RESOLVED." } ], "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": "" } ] }