{ "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": "P.O. BOX 3104", "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": "3005075696-2022-00014", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20220227", "manufacturer_address_2": "", "pma_pmn_number": "K180307", "date_of_event": "20210512", "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" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "612", "date_added": "20220227", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2054468", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20220227", "brand_name": "MAZOR X SYSTEM", "generic_name": "ORTHOPEDIC STEREOTAXIC INSTRUMENT", "manufacturer_d_name": "MAZOR ROBOTICS LTD", "manufacturer_d_address_1": "5 SHACHAM STREET", "manufacturer_d_address_2": "P.O. BOX 3104", "manufacturer_d_city": "CAESAREA HEFA,IL", "manufacturer_d_state": "", "manufacturer_d_zip_code": "30795", "manufacturer_d_zip_code_ext": "67", "manufacturer_d_country": "IS", "manufacturer_d_postal_code": "3079567", "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": "*", "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": [ "Imprecision", "Use of Device Problem", "Imprecision", "Use of Device Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250808", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "67", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6122", "patient": [ { "patient_sequence_number": "1", "date_received": "20220227", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Tissue Breakdown", "Insufficient Information", "Tissue Breakdown", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20220227", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "13615023", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220201", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "30795", "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": "288397408", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: LEE N, BUCHANAN I, BODDAPATI V, MATHEW J, MARCIANO G, PARK P, LEUNG E, BUCHHOLZ A, POLLINA J, JAZINI E, HAINES C, SCHULER T, GOOD C, LOMBARDI J, LEHMAN R. DO ROBOT-RELATED COMPLICATIONS INFLUENCE YEAR REOPERATIONS AND OTHER CLINICAL OUTCOMES AFTER ROBOT-ASSISTED LUMBAR ARTHRODESIS? A MULTICENTER ASSESSMENT OF 320 PATIENTS. JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH. (2021) 16:308. HTTPS://DOI.ORG/10.1186/S13018-021-02452-Z IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "288397409", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ABSTRACT: ROBOT-ASSISTED PLATFORMS IN SPINE SURGERY HAVE RAPIDLY DEVELOPED INTO AN ATTRACTIVE TECHNOLOGY FOR BOTH THE SURGEON AND PATIENT. ALTHOUGH CURRENT LITERATURE IS PROMISING, MORE CLINICAL DATA IS NEEDED. THE PURPOSE OF THIS PAPER IS TO DETERMINE THE EFFECT OF ROBOT-RELATED COMPLICATIONS ON CLINICAL OUTCOMES THIS MULTICENTER STUDY INCLUDED ADULT (=18 YEARS OLD) PATIENTS WHO UNDERWENT ROBOT-ASSISTED LUMBAR FUSION SURGERY FROM 2012-2019. THE MINIMUM FOLLOW-UP WAS 1 YEAR AFTER SURGERY. BOTH BIVARIATE AND MULTIVARIATE ANALYSES WERE PERFORMED TO DETERMINE IF ROBOT-RELATED FACTORS WERE ASSOCIATED WITH REOPERATION WITHIN 1 YEAR AFTER PRIMARY SURGERY. A TOTAL OF 320 PATIENTS WERE INCLUDED IN THIS STUDY. THE MEAN (STANDARD DEVIATION) CHARLSON COMORBIDITY INDEX WAS 1.2 (1.2) AND 52.5% OF PATIENTS WERE FEMALE. INTRAOPERATIVE ROBOT COMPLICATIONS OCCURRED IN 3.4% OF PATIENTS AND INCLUDED INTRAOPERATIVE EXCHANGE OF SCREW (0.9%), ROBOT ABANDONMENT (2.5%), AND RETURN TO THE OPERATING ROOM FOR SCREW EXCHANGE (1.3%). THE 1-YEAR REOPERATION RATE WAS 4.4%. ROBOT FACTORS, INCLUDING ROBOT TIME PER SCREW, OPEN VS. PERCUTANEOUS, AND ROBOT SYSTEM, WERE NOT STATISTICALLY DIFFERENT BETWEEN THOSE WHO REQUIRED REVISION SURGERY AND THOSE WHO DID NOT (P>0.05). PATIENTS WITH ROBOT COMPLICATIONS WERE MORE LIKELY TO HAVE PROLONGED LENGTH OF HOSPITAL STAY AND BLOOD TRANSFUSION, BUT WERE NOT AT HIGHER RISK FOR 1-YEAR REOPERATIONS. THE MOST COMMON REASONS FOR REOPERATION WERE WOUND COMPLICATIONS (2.2%) AND PERSISTENT SYMPTOMS DUE TO INADEQUATE DECOMPRESSION (1.5%). IN THE MULTIVARIATE ANALYSIS, ROBOT RELATED FACTORS AND COMPLICATIONS WERE NOT INDEPENDENT RISK FACTORS FOR 1-YEAR REOPERATIONS. REPORTED EVENTS: ONE PATIENT UNDERGOING LUMBAR ARTHRODESIS USING THE GUIDANCE SYSTEM REQUIRED A REVISION FOR SCREW REMOVAL AND/OR EXCHANGE. THERE WAS NO INJURY TO MOTOR/SENSORY FUNCTION. FOUR PATIENTS UNDERGOING LUMBAR ARTHRODESIS USING THE GUIDANCE SYSTEM REQUIRED A REVISION DURING THE INITIAL HOSPITAL STAY FOR SCREW REMOVAL AND/OR EXCHANGE. THERE WAS NO INJURY TO MOTOR/SENSORY FUNCTION. AFTER USE OF THE GUIDANCE SYSTEM FOR LUMBAR ARTHRODESIS, SIX PATIENT EXPERIENCED WOUND COMPLICATIONS WITHIN 90 DAYS AFTER THE SURGERY. A REVISION PROCEDURE WAS REQUIRED. AFTER USE OF THE GUIDANCE SYSTEM FOR LUMBAR ARTHRODESIS, ONE PATIENT EXPERIENCED A WOUND COMPLICATION BETWEEN 91 DAYS AND A YEAR AFTER SURGERY. A REVISION PROCEDURE WAS REQUIRED. DURING USE OF THE GUIDANCE SYSTEM FOR LUMBAR ARTHRODESIS, MALPOSITIONED SCREWS WERE REPOSITIONED DURING THREE PROCEDURES. THERE WAS NO INJURY TO MOTOR/SENSORY FUNCTION." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "5 SHACHAM STREET", "distributor_zip_code": "", "manufacturer_contact_postal_code": "55432", "manufacturer_contact_exchange": "612", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }