{ "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": "3005075696-2024-00065", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20240607", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240322", "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", "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": "20240607", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1285897", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240607", "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": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "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": "20240607", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "69 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Bacterial Infection", "Fever", "Insufficient Information", "Bacterial Infection", "Fever", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240607", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "19484806", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240516", "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": "344271351", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PHAM, M. H., HERNANDEZ, N. S., & STONE, L. E. (2024). PREOPERATIVE ROBOTICS PLANNING FACILITATES COMPLEX CONSTRUCT DESIGN IN ROBOT-ASSISTED MINIMALLY INVASIVE ADULT SPINAL DEFORMITY SURGERY¿A PRELIMINARY EXPERIENCE. JOURNAL OF CLINICAL MEDICINE, 13(7), 1829. HTTPS://DOI.ORG/10.3390/JCM13071829. BACKGROUND: THE CORRECTION OF ADULT SPINAL DEFORMITY (ASD) CAN REQUIRE LONG, COMPLEX CONSTRUCTS WITH MULTIPLE RODS WHICH TRAVERSE IMPORTANT BIOMECHANICAL LEVELS TO ACHIEVE MULTI-PELVIC FIXATION. MINIMALLY INVASIVE (MIS) PLACEMENT OF THESE CONSTRUCTS HAS HISTORICALLY BEEN DIFFICULT. ADVANCED TECHNOLOGIES SUCH AS SPINAL ROBOTICS PLATFORMS CAN FACILITATE THE DESIGN AND PLACEMENT OF THESE CONSTRUCTS AND FURTHER ENABLE THESE SURGICAL APPROACHES IN MIS DEFORMITY SURGERY. METHODS: A RETROSPECTIVE STUDY WAS PERFORMED ON A SERIES OF ASD PATIENTS UNDERGOING MIS DEFORMITY CORRECTION WITH =EIGHT FUSION LEVELS TO THE LOWER THORACIC SPINE WITH PREOPERATIVE ROBOTIC CONSTRUCT PLANNING AND ROBOT-ASSISTED PEDICLE SCREW PLACEMENT. RESULTS: THERE WERE 12 PATIENTS (10 FEMALE, MEAN AGE 68.6 YEARS) WITH A DIAGNOSIS OF EITHER DEGENERATIVE SCOLIOSIS (8 PATIENTS) OR SAGITTAL IMBALANCE (4 PATIENTS). ALL UNDERWENT PREOPERATIVE ROBOTIC PLANNING TO ASSIST IN MIS ROBOT-ASSISTED PERCUTANEOUS OR TRANSFASCIAL PLACEMENT OF PEDICLE AND ILIAC SCREWS WITH MULTIPLE-ROD CONSTRUCTS. MEAN OPERATIVE VALUES PER PATIENT WERE 9.9 LEVELS INSTRUMENTED (RANGE 8¿11), 3.9 INTERBODY CAGES (RANGE 2¿6), 3.3 ILIAC FIXATION POINTS (RANGE 2¿4), 3.3 RODS (RANGE 2¿4), 18.7 SCREWS (RANGE 13¿24), ESTIMATED BLOOD LOSS 254 CC (RANGE 150¿350 CC), AND OPERATIVE TIME 347 MIN (RANGE 242¿442 MIN). ALL PATIENTS SHOWED IMPROVEMENT IN RADIOGRAPHIC SAGITTAL, AND, IF APPLICABLE, CORONAL PARAMETERS. MEAN LENGTH OF STAY WAS 5.8 DAYS WITH NO ICU ADMISSIONS. TEN PATIENTS AMBULATED ON POD 1 OR 2. OF 224 SCREWS PLACED MINIMALLY INVASIVELY, FOUR BREACHES WERE IDENTIFIED ON INTRAOPERATIVE CT AND REPOSITIONED (THREE LATERAL, ONE MEDIAL) FOR A ROBOT-ASSISTED SCREW ACCURACY OF 98.2%. CONCLUSIONS: MINIMALLY INVASIVE LONG-SEGMENT FIXATION FOR ADULT SPINAL DEFORMITY SURGERY HAS HISTORICALLY BEEN CONSIDERED LABORIOUS AND TECHNICALLY INTENSIVE. PREOPERATIVE ROBOTICS PLANNING FACILITATES THE DESIGN AND PLACEMENT OF EVEN COMPLEX MULTI-ROD MULTI-PELVIC FIXATION FOR MIS DEFORMITY SURGERY. REPORTED EVENT TWELVE PATIENTS UNDERWENT MIS DEFORMITY SURGERY TO ADDRESS ASD. IT WAS FOUND THAT FOUR SCREWS BREACHED(THREE LATERAL, ONE MEDIAL) AND THEY HAD TO BE REPOSITIONED. IT WAS ALSO NOTED THAT TWO PATIENTS HAD TO BE REOPERATED ON DUE TO PROXIMAL JUNCTIONAL FAILURE. ONE PATIENT PRESENTED WITH EARLY RADIOGRAPHIC EVIDENCE OF PROXIMAL JUNCTIONAL KYPHOSIS AFTER A MECHANICAL FALL, BUT WAS ASYMPTOMATIC. ONE PATIENT SUFFERED ASPIRATION PNEUMONIA BETWEEN THE FIRST AND SECOND STAGE SURGERIES. THIS RESULTED IN A PROLONGED HOSPITAL STAY FOR RESPIRATORY RECOVERY AND PERSISTENT DRUG FEVERS." }, { "mdr_text_key": "344271352", "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 AVERAGE 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 AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B5 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. E1901 - ASPIRATION PNEUMONIA E230101 - PERSISTENT DRUG FEVERS E2401 - PROXIMAL JUNCTIONAL FAILURE. 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": "" } ] }