{ "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": "3005075696-2020-00088", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200529", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20200505", "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": "20200529", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "565119", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200529", "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. 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": "", "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": "20200601", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Use of Device Problem", "Use of Device Problem" ], "reporter_state_code": "VA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "06/01/2020", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200529", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "", "patient_weight": "67", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Known Impact Or Consequence To Patient" ] } ], "distributor_city": "", "date_report": "20200615", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10100902", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200505", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "193033180", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "193033181", "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 A T9-PELVIS CASE WAS BEING DONE. TWO PINS WERE PLACED IN THE PSIS TO MOUNT THE SURGICAL SYSTEM TO THE PATIENT. THE MANUFACTURER REPRESENTATIVE NOTED THAT THERE WAS A ROTATION IN THE SPINE. FOR THE T9-L2 SCREWS, THE LEFT SIDE WAS MEDIAL AND THE RIGHT SIDE WAS LATERAL. FOR THE SECOND SEGMENT, L3 TO S2AI, REGISTRATION WAS DONE AND THE SCREWS WERE PLACED. THE SCREWS ON THE LEFT SIDE WERE LATERAL AND MEDIAL ON THE RIGHT SIDE. THE REPRESENTATIVE DID NOT BELIEVE THERE WAS A TECHNIQUE ISSUE. THE S2 SCREWS WERE ACCURATE, BUT ALL OTHER SCREWS WERE SUPERIOR TO PLAN. A REVISION HAD TO BE DONE TO REPOSITION THE SCREWS. THERE WAS NO PATIENT HARM AND THE PROCEDURE WAS NOT DELAYED MORE THAN AN HOUR." }, { "mdr_text_key": "317317599", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3: A SOFTWARE ANALYSIS WAS INITIATED. CLINICAL EXPORT DATA FILE WAS THOROUGHLY INSPECTED. THE LOG FILE WAS EXAMINED IN ORDER TO INSPECT AND UNDERSTAND PROCEDURE WORKFLOW. FLUOROSCOPIC IMAGES WERE CHECKED AND 3D REGISTRATION WAS ATTEMPTED WITH THE REGISTRATION 3D MARKER IMAGES UTILIZED DURING THE OPERATION ON A MAZOR X R<(>&<)>D WORKSTATION. THIS CASE INCLUDED TWO SEGMENTS WHICH WERE OPERATED ON SEPARATELY: (1) T9-L2 LEVELS AND (2) L3-S2 LEVELS. SINCE THIS WAS AN OPEN CASE AND TWO SCHANZ SCREWS WERE PLACED IN THE PSIS AS A CHOSEN PLATFORM, THE ENTIRE FIRST SEGMENT WAS EXECUTED OUTSIDE THE RECOMMENDED OPERATIONAL RANGE, MEANING ALL VERTEBRAE T9-L2, INCLUDING L3 FROM THE LOWER SEGMENT, WERE MOBILE. FROM THE AP INTRA-OPERATIVE IMAGE PROVIDED (ATTACHED BELOW), BOTH SCHANZ SCREWS WERE INSERTED NEAR THE SI JOINTS (BOTH JOINTS ARE MARKED IN RED CIRCLES), INSTEAD OF THE PSIS AS INSTRUCTED IN THE SURGICAL TECHNIQUE GU IDE. MISS-PLACEMENT OF THE PLATFORM MAY LEAD TO INSTABILITY, AND CAUSE DEVIATIONS FOR ALL OPERATED TRAJECTORIES. THE PATIENT'S OSTEOPOROTIC CONDITION, IN CONJUNCTION WITH MISPLACEMENT OF THE SCHANTZ SCREWS, SUGGESTS THE PLATFORM WAS NOT EFFECTIVE. ANALYSIS REPRODUCED THE REGISTRATION RESULTS. THE REGISTRATION WAS SUCCESSFUL, RESULTED IN GREEN VALUES FOR ALL VERTEBRAE WITH NO APPARENT SHIFTS. AFTER REVIEWING ALL AVAILABLE INFORMATION, TWO MAJOR ISSUES WERE FOUND. THE ENTIRE UPPER SEGMENT (INCLUDING L3 FROM THE LOWER SEGMENT) WAS OUTSIDE THE OPERATIONAL RANGE, MEANING THAT T9-L3 TRAJECTORIES WERE PERFORMED ON A MOBILE SPINE. PLACING SCHANZ SCREWS NOT IN THE PSIS RESULTED IN SUB-OPTIMAL FIXATION, WHICH WAS WORSEN BY THE PATIENT'S OSTEOPOROTIC BONE QUALITY. GIVEN THE FACT THAT THIS WAS A HIGH BMI PATIENT WITH OSTEOPOROTIC BONE, THE COMBINATION OF A POSSIBLE WATERBED AFFECT AND A FIXATION METHOD THAT DOES NOT SUIT THIS SPECIFIC CASE, HAVE LED TO A HIGHLY MOBILE SPINE AND RESULTED IN MULTIPLE DEVIATED SCREWS (THE PATTERN OF THE DEVIATIONS IS TYPICAL TO THIS KIND OF PHENOMENA AND CAN BE EXPECTED). 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": "317317600", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE REPORTED THE DEVIATION WAS LESS THAN 3.5 MM. DURING THE INITIAL PROCEDURE, THE SURGEON WAS INSTRUMENTING FROM THE RIGHT SIDE OF THE PATIENT AND THEIR RESIDENT WAS INSTRUMENTING FROM THE LEFT SIDE. THE SURGEON HAD VERIFIED THE PLATFORM WAS RIGID AND THEY HAD NOT LEANED ON THE PATIENT DURING THE PROCEDURE. A REVISION WAS DONE A WEEK LATER SO THE SURGEON COULD REPOSITION THE SCREWS FREEHAND. THE SURGEON INDICATED THAT SOME OF THE SCREWS WERE REMOVED DURING THE REVISION." } ], "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": "06/15/2020" } ] }