{ "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": "P.O. BOX 3104", "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": "3005075696-2022-00077", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20221027", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20220920", "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": [ "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20221027", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20190717", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2720573", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221027", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. 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PENDING COMPLETION OF ANALYSIS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "302507810", "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 SYSTEM APPEARED TO REGISTER BUT ACCURACY SEEMED TO BE OFF SIGNIFICANTLY RESULTING IN MISPLACED SCREWS. AT THE TIME OF THE COMPLAINT COMING IN, THE CONFIRMATION SPIN HAD NOT YET BEEN TAKEN, SO EXACT DETAILS OF PLACEMENT WERE NOT YET KNOWN, LIKELY MEDIAL ON THE LEFT AND LATERAL ON THE RIGHT. THE PROCEDURE WAS ON L4-L5, PLACED RIGHT FIRST THEN LEFT, USING CT TO FLUORO WORKFLOW. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS ASSUMED THAT THE TRAJECTORIES WERE OFF GREATER THAN10MM BECAUSE TWO WERE NOT IN BONE. THE SCREWS WERE REMOVED PRIOR TO THE CONFIRMATION SPIN. TWO OF THESE SCREWS PATHWAYS WERE NOT ABLE TO BE LOCATED. NO SCREWS WERE REPLACED AT THE TIME OF THE CASE. THE CASE WAS NOT COMPLETED. THE SCREWS WERE TAKEN OUT AND THE CASE WAS ABORTED. THERE HAS BEEN NO NOTIFICATION ON RESCHEDULING THE CASE." }, { "mdr_text_key": "336765994", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2) SEE B5. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "336765995", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED STATING THAT ONCE SEDATED AND INTUBATED, THE PATIENT WAS THEN APPROPRIATELY PLACED FOR A SINGLE POSITION SURGERY ON THE OSI FLAT TOP TABLE. THE RIGHT-SIDED SCREWS WERE PLACED PER PLAN WITH NO EVIDENCE OF EMG ACTIVITY OR CHANGES FROM THE NEUROMONITORING. THE PATIENT OF NOTE WAS FULLY RELAXED AT THIS POINT. ATTENTION WAS THEN TAKEN TO THE LEFT-SIDED SCREWS. THE L4 WAS PLACED FIRST, FOLLOWED BY L5. DURING THE PREPARATION FOR THE LEFT (L5) SCREWS, THE PATIENT ¿BUCKED¿ THE VENTILATOR, HOWEVER THE SURGEON REPORTED NO SIGNIFICANT MOVEMENT, AND CONTINUED WITH THE PLACEMENT OF THE LEFT L4 AND L5 SCREWS. FOLLOWING STANDARD PROTOCOL, X-RAYS WERE THEN OBTAINED NOTING THE LEFT L4 AND L5 SCREWS WERE IN A VERY SUBOPTIMAL POSITION, ESPECIALLY ON THE AP. THE SURGEON THEN REMOVED ALL SCREWS , AND CT SCAN IMAGING WAS OBTAINED AND REVIEWED BY THE SURGEON. THE SURGEON OBSERVED NO GROSS EVIDENCE OF SPINAL CANAL VIOLATION, HOWEVER ABORTED THE PROCEDURE SO THAT HE COULD PERFORM A NEUROLOGICAL EXAM AND FULLY EVALUATED THE PATIENT. ONCE THE PATIENT WAS AWAKENED IN THE RECOVERY ROOM, THE SURGEON OBSERVED WEAKNESS IN HER LEFT EHL (EXTENSOR HALLUCIS LONGUS) WHICH WAS NEW WITH NEW NUMBNESS IN HER LEFT FOOT AND SOLE. FOLLOWING THIS SURGERY, THE PATIENT HAS BEEN DEALING WITH SEVERE NEUROPA THIC PAIN IN THE L5-S2 DERMATOME SOON ACCOMPANYING LEFT LEG WEAKNESS AND BOWEL/BLADDER INCONTINENCE. HER UNCONTROLLED PAIN IS ADDITIONALLY RESULTING IN ACCOMPANYING MYOFASCIAL PAIN, BURSITIS ON RIGHT HIP, AND REACTIVE DEPRESSION. SHE HAD BEEN ASSESSED AND THERE IS NO INFECTION. THE PATIENT DEMONSTRATES A LOSS OF RIGHT LOWER EXTREMITY STRENGTH, REDUCED STAMINA OR DAILY TASKS, AND DECREASED GAIT PATTERN. ADDITIONALLY THE PATIENT SUFFERED NERVE DAMAGE ON THE LEFT SIDE OF HER LUMBAR SPINE, RESULTING IN PAIN, WEAKNESS, AND NUMBNESS IN HER LEFT GROIN REGION. SHE SUFFERED PERMANENT NUMBNESS AND PAIN FROM THE NERVE DAMAGE ON HER LOWER LEFT SIDE THAT EXTENDED FROM THE TOP OF HER BUTTOCK DOWN HER LEFT LEG, AND INCLUDED HER VAGINA AND ANUS, AND SHE SUFFERED OTHER SIGNIFICANT PERSONAL INJURIES AND OTHER DAMAGES." }, { "mdr_text_key": "332777379", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A CLINICAL ANALYSIS WAS COMPLETED AND AFTER REVIEWING ALL OF THE AVAILABLE INFORMATION, THE INVESTIGATING TEAM CONCLUDED THAT THE ROOT CAUSE FOR THE DEVIATIONS EXPERIENCED IN THE OPERATING ROOM IS A PATIENT SHIFT THAT HAPPENED AFTER SCANNING WAS COMPLETED. DUE TO THE PATIENT'S HIGH BMI AND LATERAL POSITION, IT IS POSSIBLE THAT THE PATIENT SANK INTO THE BED, LEADING TO THE MEDIAL-LATERAL DEVIATION PATTERN OBSERVED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "332777432", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A1-A4: THE PATIENT INFORMATION WAS PROVIDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55112", "manufacturer_contact_exchange": "763", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/04/2022;11/17/2022;09/12/2023;02/09/2026" } ] }