{ "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": "7000 CENTRAL AVENUE NE RCW215", "manufacturer_g1_city": "CAESAREA HEFA,IL", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "61227132", "event_type": "Injury", "report_number": "3005075696-2024-00016", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240207", "manufacturer_address_2": "", "pma_pmn_number": "K230064", "date_of_event": "20240202", "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": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20240207", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20190101", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1907693", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240207", "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", "device_report_product_code": "OLO", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/03/2024", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250819", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20240207", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "65 YR", "patient_sex": "Female", "patient_weight": "80 KG", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Paraplegia", "Paraplegia" ] } ], "distributor_city": "", "date_report": "20240513", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "18660705", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240202", "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": "334779587", "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 WHILE USING THE NEW 5.1.1 SOFTWARE, THE NAVIGATION WAS SHOWING THE SCREW HIT THE BULLSEYE DEPTH, BUT THE SCREW WAS STILL PROUD. THE SURGEON CHECKED THE DEPTH WITH A PROBE AND BELIEVED IT WAS AT 40MM DEEP, INSTEAD OF 50 MM DEEP. THE SNAPSHOT WAS REDONE TO MAKE SURE ACCURACY WAS GOOD. THE SITE TOUCHED THE LAMINA WITH THE PASSIVE PLANAR PROBE AND THE SYSTEM SHOWED THAT IT WAS 5-10 MM PAST WHERE IT WAS LOCATED. AN ACCURACY CHECK ON THE DIVOT OF THE ARM GUIDE WAS MATCHING. THE REGISTRATION WAS REDONE AND THE SITE HAD TO AIRPLANE THE BED TO CONFIRM HOW DEEP THE SCREWS ACTUALLY WERE AND THEY WERE ABLE TO SEE THERE WAS PLENTY OF ROOM LEFT. WHEN AIRPLANING THE BED, THE SITE BELIEVED THE PATIENT ANATOMY SHIFTED SO THE ORIGINAL PILOT HOLE WAS INFERIOR AND MEDIAL. DURING THE LEFT L3 SEGMENT, THE SURGEON B REACHED THE INTERVERTEBRAL CANAL AND CENTRAL CANAL. NEUROMONITORING INDICATED SIGNAL LOSS ON THE LEFT SIDE. DESPITE THE CHALLENGES, THE PATIENT DID REGAIN THE ABILITY TO MOVE THEIR LEGS POST-OPERATION. DURING THE LEFT L3 PART, THE NAVIGATION SYSTEM INDICATED A 5 MM INSTRUMENT DEPTH ANOMALY AT L4. DESPITE MULTIPLE ATTEMPTS TO ADDRESS THIS, THE PROBLEM PERSISTED. SUBSEQUENT CONFIRMATION X-RAYS REVEALED THAT THE L4 AND L5 SCREWS WERE PROUD. THE GUIDANCE SYSTEM WAS ABORTED FOR NAVIGATION FOR THE REMAINDER OF THE CASE. THE PROCEDURE WAS DELAYED LESS THAN ONE HOUR." }, { "mdr_text_key": "334779588", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H3, H6: NO PARTS HAVE BEEN RETURNED AT THIS TIME FOR 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": "342325098", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "H6: THE EXPORTS WERE RETURNED FOR CLINICAL ANALYSIS. THE ANALYSIS DETERMINED THAT THE ROOT CAUSE OF THE DEPTH INACCURACIES WAS DUE TO PATIENT SHIFT, POSSIBILITY DUE TO THE PATIENT SINKING IN THE BED. 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": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "05/13/2024" } ] }