{ "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": "3005075696-2026-00078", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260330", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20260131", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "55112", "reporter_occupation_code": "PHYSICIAN", "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": "FR", "manufacturer_contact_area_code": "", "date_added": "20260331", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "785277", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260330", "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": [ "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260617", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "30", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260330", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "33 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Urinary Retention", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260330", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24731390", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260304", "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": "397061328", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A.1-A.5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.4. THE PATIENT'S WEIGHT WAS NOT PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE 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. E.1. STREET 1 - INSTITUTE OF PHARMACY AND MATERIOVIGILAN 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. E2401 - ILEUS E1309 - URINARY RETENTION 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": "397061329", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "KERAUDY, A., DE BUCK, P., HAETTEL, P., GHANNAM, B., ASSAKER, R., LEROY, H.-A. (2026). 2-STAGED ROBOT-ASSISTED VERTEBRECTOMY FOR METASTATIC LUMBAR SPINE LESION: A PROOF-OF-CONCEPT CASE. EUROPEAN SPINE JOURNAL. HTTPS://DOI.ORG/10.1007/S00586-025-09713-Z SUMMARY: PURPOSE: SPINAL METASTASES FROM TESTICULAR NON-SEMINOMATOUS GERM CELL TUMORS (NSGCTS) ARE EXTREMELY RARE AND MAY REQUIRE COMPLEX SURGICAL STRATEGIES. THIS CASE AIMS TO ILLUSTRATE THE ROLE OF ROBOT-ASSISTED SPINE SURGERY (RASS) IN ACHIEVING ONCOLOGICAL RESECTION AND SPINAL STABILIZATION IN THE CONTEXT OF VERTEBRAL INVASION. METHODS: A 33-YEAR-OLD MALE WITH METASTATIC NSGCT PRESENTED WITH LOCALIZED L3 VERTEBRAL INVOLVEMENT. A TWO-STAGE SURGICAL APPROACH WAS PERFORMED. THE FIRST STAGE INVOLVED POSTERIOR DECOMPRESSION AND VERTEBRAL RESECTION. PEDICLE SCREW PLACEMENTS AND OSTEOTOMIES WERE PERFORMED UNDER ROBOT-ASSISTED GUIDANCE. THE SECOND STAGE CONSISTED OF ANTERIOR TUMOR AND VERTEBRAL BODY RESECTION VIA LAPAROTOMY, FOLLOWED BY EXPANDABLE TITANIUM CAGE PLACEMENT. RESULTS: COMPLETE VERTEBRECTOMY AND TUMOR RESECTION WERE ACHIEVED WITH NO POSTOPERATIVE NEUROLOGICAL DEFICITS. THE ROBOT-ASSISTED TECHNIQUE ALLOWED PRECISE EXECUTION OF COMPLEX OSTEOTOMIES AND STABILIZATION IN ACCORDANCE WITH PREOPERATIVE PLANNING. CONCLUSION: RASS IS A VALUABLE ADJUNCT IN THE MANAGEMENT OF SPINAL METASTASES, HELPING TO ACHIEVE RADICAL ONCOLOGIC GOALS WHILE PRESERVING NEUROLOGICAL FUNCTION AND SPINAL STABILITY. REPORTED EVENT: A THIRTY-THREE-YEAR-OLD MALE UNDERWENT A TWO STAGE ROBOT-ASSISTED VERTEBRECTOMY TO ADDRESS A NON-SEMINOMATOUS GERM CELL TUMOR. AFTER THE PROCEDURES THE PATIENT EXPERIENCED TRANSIENT GASTROINTESTINAL ILEUS AND URINARY RETENTION, WHICH WAS MANAGED CONSERVATIVELY. AFTER THREE MONTHS THE PATIENT'S BLADDER AND SPHINCTER DYSFUNCTION HAD MARKEDLY IMPROVED, NO LONGER REQUIRING AN INDWELLING CATHETER." } ], "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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }