{ "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": "3005075696-2024-00075", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240705", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240508", "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": [ "Literature" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20240705", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1132968", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240705", "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": "KY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250820", "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": "20240705", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "58 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bone Fracture(s)", "Unspecified Tissue Injury", "Bone Fracture(s)", "Unspecified Tissue Injury" ] } ], "distributor_city": "", "date_report": "20240705", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "19680888", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240624", "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": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "346267759", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WERTHMANN, N. J., GUM, J. L., NAGATA, K., DJURASOVIC, M., GLASSMAN, S. D., OWENS, R. K., CRAWFORD, C. H., <(>&<)> CARREON, L. Y. (2024). COMPARISON OF NO TAP (TWO-STEP) AND TAPPING ROBOTIC ASSISTED CORTICAL BONE TRAJECTORY SCREW INSERTION. JOURNAL OF ROBOTIC SURGERY, 18(1). HTTPS://DOI.ORG/10.1007/S11701-024-01890-1 SUMMARY: WORKFLOW FOR CORTICAL BONE TRAJECTORY (CBT) SCREWS INCLUDES TAPPING LINE-TO-LINE OR UNDER TAPPING BY 1 MM. WE DESCRIBE A NON-TAPPING, TWO-STEP WORKFLOW FOR CBT SCREW PLACEMENT, AND COMPARE THE SAFETY PROFILE AND TIME SAVINGS TO THE TAP (THREE STEP) WORKFLOW. PATIENTS UNDERGOING ROBOTIC ASSISTED 1¿3 LEVEL POSTERIOR FUSION WITH CBT SCREWS FOR DEGENERATIVE CONDITIONS WERE IDENTIFIED AND SEPARATED INTO EITHER A NO-TAP OR TAP WORKFLOW. NUMBER OF TOTAL SCREWS, SCREW-RELATED COMPLICATIONS, ESTIMATED BLOOD LOSS, OPERATIVE TIME, ROBOTIC TIME, AND RETURN TO THE OPERATING ROOM WERE COLLECTED AND ANALYZED. THERE WERE 91 CASES (458 SCREWS) IN THE NO-TAP AND 88 CASES (466 SCREWS) IN THE TAP GROUPS, WITH NO DIFFERENCE IN DEMOGRAPHICS, REVISION STATUS, ASA GRADE, APPROACH, NUMBER OF LEVELS FUSED OR DIAGNOSIS BETWEEN COHORTS. TOTAL ROBOTIC TIME WAS LOWER IN THE NO-TAP (26.7 MIN) VERSUS THE TAP GROUP (30.3 MIN, P=0.053). THERE WAS NO DIFFERENCE IN THE NUMBER OF MISPOSITIONED SCREWS IDENTIFIED INTRAOPERATIVELY (10 VS 6, P=0.427), SCREWS CONVERTED TO FREEHAND (3 VS 3, P=0.699), OR SCREWS ABANDONED(3 VS 2, P=1.000). NO PEDICLE/PARS FRACTURE OR FIXATION FAILURE WAS SEEN IN THE NO-TAP COHORT AND ONE IN THE TAP COHORT (P=1.00). NO PATIENTS IN EITHER COHORT WERE RETURNED TO OR FOR MALPOSITIONED SCREWS. THIS STUDY SHOWED THAT THE NO-TAP SCREW INSERTION WORKFLOW FOR ROBOT-ASSISTED CBT REDUCES ROBOTIC TIME WITHOUT INCREASING COMPLICATIONS. REPORTED EVENTS: ONE HUNDRED AND SEVENTY NINE PATIENTS UNDERWENT A SPINAL PROCEDURE. THERE WERE SIXTEEN MISPLACED SCREWS, SIX IN THE TAP GROUP AND TEN IN THE NON-TAP GROUP. SIX SCREWS WERE CONVERTED TO FREEHAND, THREE IN EACH GROUP. FIVE SCREWS WERE ABANDONED, TWO IN THE TAP GROUP AND THREE IN THE NON-TAP GROUP. IT WAS ALSO NOTED THAT THERE WERE SEVEN DURAL TEARS, SIX IN THE TAP GROUP, AND ONE PEDICLE FRACTURE. THE FRACTURE CAME FROM THE TAP GROUP, BUT WAS OBSERVED ON APOST-OPERATIVE CT AFTER THE PATIENT HAD FALLEN." }, { "mdr_text_key": "346267760", "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 MEDIAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.4. THE PATIENT'S WEIGHT WAS NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE DATE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. 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. E1603 - PEDICLE FRACTURE E2015 - DURAL TEAR. 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": "" } ] }