{ "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": "3005075696-2023-00018", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20230327", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20221114", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55432", "reporter_occupation_code": "OTHER HEALTH CARE PROFESSIONAL", "manufacturer_contact_plocal": "6122713209", "noe_summarized": "1", "manufacturer_contact_l_name": "BELMER", "source_type": [ "Foreign", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079567", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "612", "date_added": "20230327", "manufacturer_contact_f_name": "GLEN", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1809073", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20230327", "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": "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": [ "Imprecision", "Imprecision" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250801", "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": "20230327", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Wound Dehiscence", "Wound Dehiscence" ] } ], "distributor_city": "", "date_report": "20230327", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "16620427", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20230227", "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": "312055612", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ABSTRACT: THE AIM OF THIS STUDY WAS TO COMPARE THE INTRAOPERATIVE AND POSTOPERATIVE OUTCOMES BETWEEN A ROBOT-ASSISTED VERSUS A NAVIGATED TRANS PEDICULAR FUSION TECHNIQUE. THIS RETROSPECTIVE ANALYSIS INCLUDED PATIENTS WHO UNDERWENT TRANSPEDICULAR POSTERIOR FUSION OF THE SPINE DUE TO TRAUMA, PYOGENIC SPONDYLODISCITIS AND OSTEOPOROSIS. SURGERY WAS DONE EITHER WITH A ROBOT-ASSISTED OR A PERCUTANEOUS NAVIGATED TRANSPEDICULAR FUSION TECHNIQUE. THE OUTCOME ANALYSIS INCLUDED THE DURATION OF SURGERY, THE RADIATION EXPOSURE, THE POSTOPERATIVE SCREW POSITION AND COMPLICATIONS. A TOTAL OF 60 PATIENTS WERE OPERATED AND 491 SCREWS WERE ANALYSED. NO STATISTICAL DIFFERENCE WAS SEEN IN THE APPLIED CUMULATIVE EFFECTIVE RADIATION DOSE PER PATIENT. THE RADIOLOGICAL ASSESSMENT REVEALED A MORE ACCURATE SCREW PLACEMENT WITH ROBOT ASSISTANCE. A LEARNING CURVE COULD BE OBSERVED IN ROBOT-ASSISTED FUSION. ROBOT-ASSISTED AND NAVIGATED TRANSPEDICULAR FUSION TECHNIQUES ARE BOTH EFFECTIVE AND SAFE. ROBOT-ASSISTED TRANSPEDICULAR SPINE FUSION GOES ALONG WITH HIGHER PLACEMENT ACCURACY BUT ITS IMPLEMENTATION NEEDS AN ADEQUATE LEARNING CURVE. REPORTED EVENT: 5/60 PATIENTS HAD TO UNDERGO REVISION SURGERY AFTER TRANSPEDICULAR FUSION. REVISION SURGERY WAS DUE TO SCREW MISPLACEMENT IN TWO CASES (ONE PATIENT FROM EACH GROUP) AS WELL AS WOUND DEHISCENCE IN THE OTHER CASES. ONE PATIENT FROM THE ROBOT-ASSISTED TRANSPEDICULAR FUSION GROUP WITH A MISPLACED SCREW SUFFERED FROM A TEMPORARY RADICULAR DEFICIT DUE TO A MEDIAL PEDICLE BREACH. AFTER SCREW REPOSITIONING THE DEFICIT WAS RESOLVED COMPLETELY." }, { "mdr_text_key": "312055613", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "PLEASE NOTE THAT EVENT 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: ROMAGNA A, SPERKER S, LUMENTA C, TOMASINO A, SCHWARTZ C, LEHMBERG J, ZAUSINGER S, SCHUL D. ROBOT-ASSISTED VERSUS NAVIGATED TRANSPEDICULAR SPINE FUSION: A COMPARATIVE STUDY. WILEY - THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY. (2023). HTTPS://DOI.ORG/10.1002/RCS.2500. 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." } ], "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": "" } ] }