{ "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": "3005075696-2024-00135", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20241001", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240719", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "7635265677", "noe_summarized": "1", "manufacturer_contact_l_name": "ELLIS", "source_type": [ "Foreign", "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "CH", "manufacturer_contact_area_code": "763", "date_added": "20241001", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1948188", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20241001", "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": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "N", "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": [ "Incorrect, Inadequate or Imprecise Result or Readings", "Incorrect, Inadequate or Imprecise Result or Readings" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250822", "health_professional": "Y", "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": "20241001", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "65 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pain", "Numbness", "Pain", "Numbness" ] } ], "distributor_city": "", "date_report": "20241001", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "20345591", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240905", "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": "353077247", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A.1-A.5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE PATIENT'S WEIGHT WAS NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. H.6. MULTIPLE PATIENT CODES WERE APPLIED. BELOW LISTED WHAT EACH CORRELATES TO. E0127 - NUMB E2330 - PAIN 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": "353077248", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "TONG, M., ZHANG, S., ZHANG, W., MOU, L., DONG, Z., WANG, R., LI, S., <(>&<)> HUANG, Y. (2024). EFFICACY AND SAFETY OF NAVIGATION ROB OT-ASSISTED VERSUS CONVENTIONAL OBLIQUE LATERAL LUMBAR INTERBODY FUSION WITH INTERNAL FIXATION IN THE TREATMENT OF LUMBAR DEGENERATIVE DISEASES: A RETROSPECTIVE STUDY. MEDICINE, 103(32). HTTPS://DOI.ORG/10.1097/MD.0000000000039261 SUMMARY: EFFECTIVE INTERNAL FIXATION WITH PEDICLE SCREW IS A KEY FACTOR IN THE SUCCESS OF LUMBAR FUSION WITH INTERNAL FIXATION. WHETHER NAVIGATION ROBOTS CAN IMPROVE THE EFFICACY AND SAFETY OF SCREW PLACEMENT IS CONTROVERSIAL. THIRTY-EIGHT PATIENTS WHO UNDERWENT OBLIQUE LATERAL LUMBAR INTERBODY FUSION INTERNAL FIXATION FROM MARCH 2022 TO MAY 2023 WERE RETROSPECTIVELY ANALYZED, 16 CASES IN THE NAVIGATIONAL ROBOT GROUP AND 22 CASES IN THE FLUOROSCOPY GROUP. USING VISUAL ANALOG SCORE (VAS) FOR THE LOW BACK AND LOWER LIMBS, OSWESTRY DISABILITY INDEX TO COMPARE THE CLINICAL EFFICACY OF THE 2 GROUPS; USING PERIOPERATIVE INDEXES SUCH AS THE DURATION OF SURGERY, INTRAOPERATIVE BLOOD LOSS, INTRAOPERATIVE FLUOROSCOPY TIMES, AND POSTOPERATIVE HOSPITAL STAY TO COMPARE THE SAFETY OF THE 2 GROUPS; AND USING ACCURACY OF PEDICLE SCREWS (APS) AND THE FACET JOINT VIOLATION (FJV) TO COMPARE THE ACCURACY OF THE 2 GROUPS. POSTOPERATIVE FOLLOW-UP AT LEAST 6 MONTHS, THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE 2 GROUPS IN THE BASELINE DATA (P > .05). THE NAVIGATIONAL ROBOT GROUP¿S VAS-BACK WAS SIGNIFICANTLY LOWER THAN THE FLUOROSCOPY GROUP AT 3 DAYS POSTOPERATIVELY (P <(><<)> .05). HOWEVER, THE DIFFERENCES BETWEEN THE 2 GROUPS IN VAS-BACK AT 3 AND 6 MONTHS POSTOPERATIVELY, AND IN VAS-LEG AND OSWESTRY DISABILITY INDEX AT 3 DAYS, 3 MONTHS, AND 6 MONTHS POSTOPERATIVELY WERE NOT SIGNIFICANT (P > .05). ALTHOUGH DURATION OF SURGERY IN THE NAVIGATIONAL ROBOT GROUP WAS SIGNIFICANTLY LONGER THAN IN THE FLUOROSCOPY GROUP (P > .05), THE INTRAOPERATIVE BLOOD LOSS AND THE INTRAOPERATIVE FLUOROSCOPY TIMES WERE SIGNIFICANTLY LOWER THAN IN THE FLUOROSCOPY GROUP (P <(><<)> .05). THE DIFFERENCE IN THE PHS BETWEEN THE 2 GROUPS WAS NOT SIGNIFICANT (P > .05). THE APS IN THE NAVIGATION ROBOT GROUP WAS SIGNIFICANTLY HIGHER THAN IN THE FLUOROSCOPY GROUP, AND THE RATE OF FJV WAS SIGNIFICANTLY LOWER THAN IN THE FLUOROSCOPY GROUP (P <(><<)> .05). COMPARED WITH THE TRADITIONAL FLUOROSCOPIC TECHNIQUE, NAVIGATION ROBOT-ASSISTED LUMBAR INTERBODY FUSION WITH INTERNAL FIXATION PROVIDES LESS POSTOPERATIVE LOW BACK PAIN IN THE SHORT TERM, WITH LESS TRAUMA, LESS BLEEDING, AND LOWER RADIATION EXPOSURE, AS WELL AS BETTER APS AND LOWER FJV, RESULTING IN BETTER CLINICAL EFFICACY AND SAFETY REPORTED EVENT: SIXTEEN PATIENTS UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION TO ADDRESS LUMBAR DEGENERATIVE DISEASES. THREE SCREWS HAD A CORTICAL PENETRATION DISTANCE OF LESS THAN OR EQUAL TO TWO MILLIMETERS AND ONE SCREW HAD A PENETRATION DISTANCE BETWEEN TWO AND FOUR MILLIMETERS. TWO SCREW WERE LATERAL, BUT WERE NOT IN THE FACET JOINT, AND ONE SCREW PENETRATED THE FACET JOINT BY LESS THAN A MILLIMETER. IT WAS NOTED THAT THERE WAS ONE CASE OF POSTOPERATIVE LOWER LIMB PAIN WITH NUMBNESS. THE COMPLICATION WAS RELIEVED AFTER TWO WEEKS OF ORAL NUTRITIVE NERVE AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. SEE ATTACHED ARTICLE." } ], "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": "" } ] }