{ "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": "3005075696-2025-00361", "type_of_report": [ "Initial submission", "Followup", "Followup", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20251008", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20250912", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "User facility", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "763", "date_added": "20251008", "manufacturer_contact_f_name": "JUSTIN", "device_date_of_manufacturer": "20211219", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "687381", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20251008", "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": "20250916", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Mechanical Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Communication or Transmission Problem", "Unintended Movement", "Mechanical Problem", "Incorrect, Inadequate or Imprecise Result or Readings", "Communication or Transmission Problem", "Unintended Movement" ], "reporter_state_code": "TX", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "09/25/2025;11/03/2025;12/04/2025;02/18/2026", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260331", "health_professional": "", "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": "20251008", "sequence_number_treatment": [ "\"SEE H11.\"" ], "sequence_number_outcome": [ "Other" ], "patient_age": "64 YR", "patient_sex": "Female", "patient_weight": "54 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cerebrospinal Fluid Leakage", "Cerebrospinal Fluid Leakage" ] } ], "distributor_city": "", "date_report": "20260218", "initial_report_to_fda": "Yes", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "23246281", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250912", "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": "382010618", "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, A T1-T12 SPINAL FUSION. IT WAS REPORTED THAT AN ALLEGED INACCURACY OCCURRED. INITIALLY, THE FIRST SURFACE SCAN WAS DELETED WITHOUT USER ACTION, AND THE SECOND SURFACE SCAN WAS UNUSABLE DUE TO A SHOULDER SHIFT. A THIRD SURFACE SCAN WAS SUCCESSFULLY PERFORMED. MEDTRONIC IMAGING WAS CONDUCTED FOR SCREW PLACEMENT PLANNING AND VERIFICATION. THE FIRST SCREW WAS PLACED, BUT WHEN THE ROBOT ARM WAS MOVED TO THE SECOND SCREW LOCATION, THE SURGEON OBSERVED THAT THE LOCATION APPEARED INACCURATE. THE ROBOT ARM USE WAS HALTED, AND CHICKENFOOT WAS USED TO CONFIRM THE LOCATION OF THE FIRST SCREW PLAN, REVEALING THAT THE PLAN WAS APPROXIMATELY 1 CENTIMETER (CM) LATERAL TO THE ACTUAL FIRST SCREW PLACEMENT. THE GUIDANCE SYSTEM USE WAS ABORTED. THE SURGICAL TEAM SWITCHED TO MEDTRONIC IMAGING AND NAVIGATION SYSTEM FOR PLACEMENT OF THE REMAINING SCREWS. MEDTRONIC IMAGING SHOWED THAT THE FIRST SCREW APPEARED TO BE 1 CM MEDIAL OF THE ORIGINALLY PLANNED LOCATION, AND IT WAS REPORTED THAT THE SCREW PENETRATED THE CANAL AT P1. A CEREBROSPINAL FLUID (CSF) LEAK WAS IDENTIFIED AND WAS REPORTEDLY BEING ADDRESSED DURING THE CALL. AFTER THE CASE, AN ISSUE WAS FOUND WITH THE STAR MARKER, WHICH COULD NOT BE TIGHTENED FLUSH TO THE TARGET EXTENDER, LEAVING A GAP. SURGICAL DELAY WAS LESS THAN ONE-HOUR." }, { "mdr_text_key": "382010619", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6) THE SYSTEM WAS SERVICED IN THE FIELD. IN SUMMARY, THE SYSTEM PERFORMED AS INTENDED AND NO FAULTS WERE FOUND. CODES B01, C19, AND D14 ARE APPLICABLE. H3, H6) A CLINICAL ANALYSIS WAS PERFORMED. THE ROOT CAUSE OF THE REGISTRATION ISSUES INACCURACIES EXPERIENCED IN THE OPERATING ROOM WERE ATTRIBUTED TO IMPROPER ASSEMBLY OF THE STAR-MARKER AND FAULTY PARTS LEADING TO THE STAR-MARKER NOT SITTING FLUSH ON THE TARGET EXTENDER, WHICH RESULTED IN INCORRECT ORIENTATION REGISTRATION. B01, C13, AND D11 ARE APPLICABLE. H6) MULTIPLE ANNEX A CODES WERE APPLIED TO CAPTURE THIS EVENT. A13 CAPTURES THE SURFACE SCAN ISSUES WHILE A0908 CAPTURES THE INACCURATE SCREW PLACEMENT. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN." }, { "mdr_text_key": "392701246", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H2: ADDITIONAL INFORMATION IN SECTION B5. H2, H3, H6: A CLINICAL ANALYSIS WAS PERFORMED. IN SUMMARY, THE ROOT CAUSE OF THE INACCURACIES WAS MOST LIKELY HARDWARE RELATED, ATTRIBUTED TO IMPROPER ASSEMBLY OF THE STAR-MARKER AND FAULTY PARTS. THIS CAUSED THE STAR-MARKER NOT TO SIT FLUSH ON THE TARGET EXTENDER, RESULTING IN INCORRECT ORIENTATION OF REGISTRATION. NO SOFTWARE ANOMALIES WERE NOTED. PREVIOUSLY REPORTED CODE, B01, IS APPLICABLE, AS WELL AS C07 AND D02. SECTION E4: USER REPORT NUMBER: (B)(4). 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": "392701247", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO THE CSF LEAK AND THEY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE T1 SCREW WAS MEDIAL AND WENT [THROUGH] THE SPINAL CORD. ROBOTIC REGISTRATION OF THE PATIENT ON THE TABLE WAS FOUND OUT TO BE INACCURATE AFTER PLACEMENT OF THE LEFT T1 SCREW. THE OTHER 3 SCREWS WERE ABORTED AND AN OPEN APPROACH WITH MEDTRONIC NAVIGATION WAS ADOPTED TO PROCEED. THE ORIGINAL INTENDED PROCEDURE WAS A POSTERIOR SPINAL FUSION FROM LEVELS T1-2, USING ARTHRODESIS POSTEROLATERAL TECHNIQUE. POSTERIOR SEGMENTAL SPINAL INSTRUMENTAL AT T1/2 WAS PERFORMED. IT WAS NOTED THE MORSELIZED LOCAL AUTOGRAFT WAS HARVESTED FROM THE SAME INCISION AND AN ALLOGRAFT WAS USED FOR THE SPINE SURGERY. MULTIMODAL INTRAOPERATIVE NEUROMONITORING WAS USED AND STEREOTACTIC NAVIGATION FOR THE PLACEMENT OF SPINAL HARDWARE WAS PERFORMED." }, { "mdr_text_key": "392702148", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: THE STAR MARKER WAS RETURNED FOR ANALYSIS. PHYSICAL DAMAGE WAS REPORTED. PREVIOUSLY REPORTED CODES B01, C07, AND D02 ARE APPLICABLE. 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": "395257221", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CORRECTED: H10 (UF REF ADDED FROM H11 ON #002 FOLLOW-UP REPORT). 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": "388946124", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "CONTINUATION OF D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: KIT0571. PRODUCT ID: ASM0207. H6: MULTIPLE DEVICE CODES ARE LISTED. BELOW CLARIFIES WHAT EACH DEVICE CODE IS ASSOCIATED WITH. A0512 - SHOULDER SHIFT A05 - STAR MARKER NOT TIGHTENING FLUSH 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": "10/21/2025;11/21/2025;12/26/2025;02/18/2026" } ] }