{ "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": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2022-00090", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20221221", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20221130", "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": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20221221", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20170901", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1405923", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20221221", "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. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079567", "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": "20221214", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "07290109180465", "udi_public": "07290109180465", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Imprecision", "Imprecision" ], "reporter_state_code": "AL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "12/25/2022;12/11/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20221221", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " S", " R" ], "patient_age": "46 YR", "patient_sex": "Male", "patient_weight": "115 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cerebrospinal Fluid Leakage", "Hematoma", "Muscle Weakness/Atrophy", "Nausea", "Pain", "Numbness", "Ambulation or Postural Difficulties", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions", "Cerebrospinal Fluid Leakage", "Hematoma", "Muscle Weakness/Atrophy", "Nausea", "Pain", "Numbness", "Ambulation or Postural Difficulties", "Insufficient Information", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20250106", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "16027892", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20221130", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30795", "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": "305937621", "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 SURGICAL DEVIATION THAT OCCURRED ON (B)(6) 2022. THE ORIGINAL PLAN INCLUDED FOUR SCREW INSERTIONS; HOWEVER, ONLY ONE SCREW WAS INSERTED USING THE GUIDANCE SYSTEM. THE USE OF THE GUIDANCE SYSTEM WAS CANCELED AFTER THE DEVIATION WITH THE FIRST SCREW. THE PLAN ANGLE WAS TOO CONVERGENT, SO THE ANATOMY HAD TO BE MOVED SO THE SCREW COULD FIT THROUGH THE INCISION. ONCE THE SCREW MADE CONTACT, THE PATIENT JUMPED, CAUSING A DEVIATION. THE DOCTOR STATED THAT HE PULLED TOO HARD ON THE RETRACTOR, WHICH CAUSED THE SPINE TO SHIFT OVER. THE SURGEON DECIDED THAT A REPAIR NEEDED TO OCCUR ON THE FIRST SCREW INSERTION. A FOLLOW-UP SURGERY OCCURRED ON (B)(6) 2022 WITHOUT THE USE OF THE GUIDANCE SYSTEM USE. THE SURGEON REPORTED THAT THE PATIENT'S MOTOR FUNCTIONS ON HIS LEGS WERE DECREASED DUE TO THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THAT THE AMOUNT OF DEVIATION WAS ESTIMATED TO BE LESS THAN 3.5MM." }, { "mdr_text_key": "305937622", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "EXPORT/LOG FILES RECEIVED FOR ANALYSIS. PENDING ANALYSIS AT THE TIME OF FILING. 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. 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": "334373261", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2 ADDITIONAL INFORMATION: A1, PATIENT IDENTIFIER HAS BEEN UPDATED. H3: THE EXPORT DATA FILES WERE ANALYZED. THE INVESTIGATING TEAM REVIEWED ALL OF THE AVAILABLE INFORMATION AND CONCLUDED THAT THE MOST PROBABLE CAUSE OF THE REPORTED INACCURACY ON L2-RIGHT SCREW WAS UNILATERAL RETRACTION. TO MINIMIZE THE RISK FOR THAT TO HAPPEN, THE SURGEON COULD HAVE (1) ENLARGED THE INCISION A COUPLE CM ROSTRALLY, AND/OR (2) PULLED BILATERALLY ONTO BOTH RETRACTORS AT THE SAME TIME SO AS NOT TO SHIFT THE ANATOMY TO ONE SIDE. THE USAGE OF A SCHANZ SCREW IN AN OPEN SURGERY ABOVE L4 MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REPORTED INACCURACY. 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": "362081390", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A LEGAL REPRESENTATIVE REPORTED THE GUIDANCE SYSTEM WAS USED TO PLACE SCREWS AT L2 AND L3. RIGHT L2 WAS FOUND TO BE MEDIAL. AFTER THIS PROCEDURE THE PATIENT HAD WEAKNESS AND NUMBNESS IN THEIR RIGHT LEG. DURING THE FOLLOW-UP SURGERY, IT WAS FOUND THAT THERE WAS A HEMATOMA ASSOCIATED WITH THE RIGHT L2 PEDICLE SCREW, AND THERE WAS CSF LEAKAGE. REPAIR OF THE DUROTOMY AND HEMOSTASIS WAS ACHIEVED. THE PATIENT THEN NOTED THAT THEY HAD INCREASED RIGHT LOWER EXTREMITY WEAKNESS, AND NUMBNESS AS WELL AS BOWL AND BLADDER INCONTINENCE. THE PATIENT ALSO EXPERIENCED SEVERE PHANTOM PAIN, WHICH COULD LEAD TO NAUSEA. THE PATIENT RELIES ON A CAN FOR MOBILITY AND USES A KNEE BRACE ON UNEVEN SURFACES. THE PATIENT HAS ALSO LOST FEELING IN THEIR PENILE REGION." }, { "mdr_text_key": "362081391", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "SEE B5. H6: MULTIPLE PATIENT CODES HAVE BEEN APPLIED. BELOW CLARIFICATION IS PROVIDED ON WHAT COMPLICATION THEY ARE ASSOCIATED WITH. E0106 - CEREBROSPINAL FLUID LEAKAGE E0127 - NUMBNESS E0505 - HEMATOMA E1020 - NAUSEA E1621 - WEAKNESS E2302 - THE PATIENT RELIES ON A CAN FOR MOBILITY AND USES A KNEE BRACE ON UNEVEN SURFACES E2330 - PHANTOM PAIN E2401 - BLADDER/BOWEL INCONTINENCE 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": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "01/19/2023;01/06/2025" } ] }