{ "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": "3005075696-2024-00114", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20240903", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240809", "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": [ "Foreign", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "763", "date_added": "20240903", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20220213", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1106011", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240903", "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": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20240809", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109184838", "udi_public": "07290109184838", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "08/14/2024;09/11/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250822", "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": "20240903", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Disability" ], "patient_age": "NA", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Paralysis", "Perforation", "Ambulation or Postural Difficulties", "Paralysis", "Perforation", "Ambulation or Postural Difficulties" ] } ], "distributor_city": "", "date_report": "20241004", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20126529", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240809", "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": "351409093", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SEE B5. H6: ADDED DUE TO ALLEGED SPINAL CORD INJURY. 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": "351409094", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE MISPLACED SCREWS CAUSE A LACK OF MOTION AND SENSATION FOR THE LEFT LEG SINCE THE SPINAL CORD WAS INJURED BY THE MISPLACED SCREWS. THE REPRESENTATIVE SPOKE WITH THE SURGEON ON AUGUST 14TH, AND ACCORDING TO THE SURGEON, THE CONDITION OF THE PATIENT GOT SLIGHTLY BETTER TILL THAT DAY AS HE GOT BACK SOME SENSATION AND MOTION BUT IS STILL FAR AWAY FROM BEING ABLE TO WALK NORMAL." }, { "mdr_text_key": "350791668", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A2,A4: PATIENT AGE AND WEIGHT IS NOT AVAILABLE. H3, H6: THE EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS IS STILL IN PROGRESS. THERE ARE MULTIPLE PATIENT CODES. BELOW IDENTIFIES WHAT EACH IS ASSOCIATED WITH. E2302 - LACK OF MOTOR CONTROL IN THE LEFT LEG AND WAS NOT ABLE TO WALK. E012202 - SEVERE LEG PALSY ON THE LEFT 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": "350791669", "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 THERE WAS A MEDIAL SHIFT OF ALL SCREWS PLANNED. THE SITE GOT GREEN LIGHTS IN REGISTRATION WITH A YELLOW LIGHT FOR T11. VERIFICATION WAS DONE. NO SHIFTS DETECTED. ALL VERTEBRAE WERE APPROVED. THE SITE PLACED SEVEN SCREWS, STARTING AT T10 RIGHT, TOP DOWN IN A ZIG-ZAG PATTERN. ONE SURGEON PERFORMED THE RIGHT SIDE, WHILE THE NEW SURGEON PERFORMED THE LEFT SIDE. WHEN USING THE DRILL FOR L2 LEFT, THE LAST SCREW PLANNED, THE PATIENT'S LEGS TWITCHED AND CLEAR LIQUOR WAS VISIBLE. THE PROCEDURE WAS STOPPED, AND AN ACCURACY CHECK WAS PERFORMED. NAVIGATION WAS ACCURATE, WHERE A PLANAR POINTER WAS USED IN A FEW OTHER TRAJECTORIES WHERE SCREWS WERE PLACED, SHOWING NOTHING CONSPICUOUS. A 3D SHOT WAS USED, AND IT WAS FOUND THAT ALL SCREWS WERE SHIFTED TO THE RIGHT. THEY TOOK ALL SCREWS ON THE LEFT SIDE OUT STRAIGHT AWAY. THE SITE TRIED WAKING UP THE PATIENT AND MAKING THEM MOVE THEIR LEGS. THE PATIENT ONLY MOVED THEIR RIGHT LEG. THERE WAS A TINY REACTION OF THE TOE FOR ONE SECOND ON THE RIGHT. IT WAS NOTED BY THE MANUFACTURER REPRESENTATIVE THAT THE C-ARM TOUCHED THE ARM REST WHEN PULLING OUT AFTER A SUCCESSFUL REGISTRATION. THIS WAS NOT SEEN AS A SEVERE ENOUGH BY ANYONE IN THE ROOM, AND THE SYSTEM DID NOT DETECT A SHOULDER SHIFT. THIS MAY HAVE LED TO PATIENT MOVEMENT. THE PROCEDURE WAS DELAYED AN HOUR OR LONGER. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SYSTEM DID NOT ISSUE AN ERROR AND THE TERMINATION OF THE PROCEDURE WAS PERFORMED TO PREVENT COMPLETE PARALYSIS. THE PATIENT NEVERTHELESS SUFFERED DAMAGE (SEVERE LEG PALSY ON THE LEFT), AND EXPERIENCED LACK OF MOTOR CONTROL IN THE LEFT LEG AND WAS NOT ABLE TO WALK. A 3D SCAN WITH A NON-MEDTRONIC IMAGING SYSTEM WAS THEN TAKEN. THEY THEN TOOK THE MISPLACED SCREWS OUT AND PUT NEW SCREWS IN. THE SITE USED NAVIGATION TO PUT THE SCREWS AGAIN AFTER THEY WERE REMOVED. THE PROBABLE CAUSE NOTED WAS UPDATED TO UNDETECTED MOVEMENT / SHIFT OF THE PATIENT /ANATOMY OR A SOFTWARE ISSUE WITH THE SYSTEM. MOVEMENT OF THE PATIENT COULD HAVE LED TO THE INCIDENT." }, { "mdr_text_key": "353536389", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE EXPORTS/LOGS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE PROBABLE ROOT CAUSE OF THE REPORTED D EVIATIONS IS A PLATFORM SHIFT DUE TO INADEQUATE PLATFORM FIXATION POINTS. THE RISK OF SHIFTING OF ANATOMY FROM ITS REGISTERED LOCATION IS COVERED UNDER RISK-62664, DHF0477-01_0197. 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." } ], "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": "09/10/2024;10/04/2024" } ] }