{ "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": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3005075696-2020-00115", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20201001", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20200911", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20201001", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1081291", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20201001", "brand_name": "MAZOR X STEALTH EDITION", "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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A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "209455283", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS HAVING A REVISION SURGERY DUE TO A SCREW BEING PLACED INFERIORLY DURING A PROCEDURE ON (B)(6) 2020. THE S1 SCREW WAS DEVIATED. THE MANUFACTURER REPRESENTATIVE NOTED THAT IT WAS UNKNOWN HOW THE PLACEMENT BECAME INFERIOR AS ALL OTHER SCREW PLACEMENTS WERE NOTED TO BE FINE AND THERE WERE NO ISSUES WITH SKIVING OF THE SCREW. THE PROCEDURE WAS NOT DELAYED." }, { "mdr_text_key": "320315629", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "ANALYSIS OF THE SOFTWARE EXPORTS AND LOGS WAS COMPLETED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED WITH RESPECT TO ALL INTRAOPERATIVE FLUORO IMAGES IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUORO IMAGES WERE CHECKED AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR WORKSTATION. ACCORDING TO INFORMATION PROVIDED FROM THE REPRESENTATIVE, NO FACETECTOMY OR LAMINECTOMY PERFORMED DURING THE CASE. ANALYSIS REVIEWED THE PLANNING AND AN INFERIOR SKIVING POTENTIAL WAS NOTICED AT S1 LEFT. THE FACET CAN INTERFERE WITH THE PLANNED TRAJECTORY AND WILL DIRECT THE TOOLS TO INFERIOR PATH THEN PLANNED. THE REGISTRATION WAS UPLOADED, PERFORMED AND VALIDATED TO BE ACCURATE. THE ORDER OF THE SCREW PLACEMENT WAS REVIEWED AND S1 TRAJECTORY, WAS THE THIRD TRAJECTORY TO BE PLACED AFTER SUCCESSFUL PLACEMENT OF TWO K-WIRES AND FOLLOWED BY ACCURATE PLACEMENT OF 3 K-WIRES. THIS CAN INDICATE THAT A PLATFORM OR PATIENT SHIFT IS NOT THE CAUSE FOR THE DEVIATION. ANALYSIS REVIEWED ALL THE AVAILABLE INFORMATION AND CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THE DEVIATION AT S1 LEFT WAS SKIVING OF THE TOOLS. THE REGISTRATION, PLATFORM PLACEMENT AND THE ORDER OF THE K-WIRE PLACEMENT DID NOT REVEAL ANY ADDITIONAL POTENTIAL CAUSES FOR THE DEVIATION. 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": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "11/01/2020" } ] }