{ "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": "3005075696-2026-00058", "type_of_report": [ "Initial submission" ], "product_problem_flag": "Y", "date_received": "20260225", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20251120", "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": [ "Literature", "Health Professional" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "3079830", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20260225", "manufacturer_contact_f_name": "JUSTIN", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "504449", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260225", "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" ], "reporter_state_code": "CA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20260327", "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": "20260225", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " S", " L" ], "patient_age": "63 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Dural Tear", "Pulmonary Embolism", "Anemia", "Atrial Fibrillation", "Bone Fracture(s)", "Hematoma", "Hypersensitivity/Allergic reaction", "Low Blood Pressure/ Hypotension", "Unspecified Infection", "Muscle Weakness/Atrophy", "Nausea", "Nerve Damage", "Neuropathy", "Pain", "Sepsis", "Urinary Tract Infection", "Vomiting", "Great Vessel Perforation", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Thrombosis/Thrombus", "Hyponatremia", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20260225", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MOUNDS VIEW", "mdr_report_key": "24446535", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260203", "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": "394019493", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "ETIGUNTA, S. K., WALKER, C. T., GAUSPER, A., GALOUSTIAN, N., LIU, A., GOWD, A. K., CHAN, V., ANAND, N., NOMOTO, E., PERRY, T. G., SODHA, S., JOHNSON, J. P., SKAGGS, D. L., KIM, T. (2025). DECREASED ROBOT-RELATED COMPLICATIONS FOLLOWING THE DEVELOPMENT AND ADOPTION OF A STANDARDIZED SAFETY PROTOCOL. JOURNAL OF BONE AND JOINT SURGERY, 108(1), 45¿50. HTTPS://DOI.ORG/10.2106/JBJS.25.00406 SUMMARY: BACKGROUND: ROBOT-ASSISTED SPINE SURGERY (RASS) ENABLES PRECISE PEDICLE SCREW INSERTION VIA PRE-PLANNED TRAJECTORIES, AND YET COMPLICATIONS REMAIN A NOTABLE CONCERN. PRIOR WORK SUGGESTS THAT OSSEOUS PEDICLE WALL BREACHES FROM INSTRUMENTATION AND ENSUING COMPLICATIONS RELATED TO ROBOTIC SURGERY MAY BE FROM SHIFTING OF THE REFERENCE FRAME OR IMPROPER METHODOLOGY. IN THIS STUDY, WE HYPOTHESIZED THAT THE INTRODUCTION OF STANDARDIZED INSTITUTIONAL GUIDELINES FOR RASS WOULD REDUCE COMPLICATIONS ASSOCIATED WITH ROBOTIC SCREW PLACEMENT. METHODS: THIS RETROSPECTIVE COHORT STUDY INCLUDED PATIENTS WHO UNDERWENT RASS USING 2 ROBOTIC SYSTEMS AT A SINGLE INSTITUTION. WE ANALYZED THE CASES OF 264 PATIENTS IN A HISTORICAL COHORT BEFORE, AND 290 PATIENTS AFTER, THE IMPLEMENTATION OF A STANDARDIZED INSTITUTIONAL PROTOCOL DEVELOPED TO ENSURE SAFETY WITH ROBOTIC PLACEMENT OF PEDICLE SCREWS. THE PROTOCOL PROVIDED SURGEONS WITH DETAILED GUIDELINES FOR REFERENCE-FRAME PLACEMENT, INTRAOPERATIVE SCREW TRAJECTORY AND ALIGNMENT CHECKS, DEPTH OF DRILL INSERTION, VERIFICATION OF SCREW POSITIONING, NEUROMONITORING FOR THORACIC INSTRUMENTATION, AND POSTOPERATIVE IMAGING. PATIENT DEMOGRAPHICS, PREOPERATIVE DIAGNOSES, SURGICAL CHARACTERISTICS, AND COMPLICATIONS WERE COLLECTED FOR ALL PATIENTS. RESULTS: THERE WAS NO DIFFERENCE BETWEEN THE PRE-PROTOCOL AND POST-PROTOCOL GROUPS WITH RESPECT TO PATIENT DEMOGRAPHICS. IN THE PRE- PROTOCOL COHORT, 6 (2.3%) OF THE PATIENTS EXPERIENCED ROBOT-RELATED COMPLICATIONS, INCLUDING NERVE INJURY, DUROTOMY, AND MALPOSITIONED SCREWS, WITH HALF OF THESE COMPLICATIONS ATTRIBUTED TO REFERENCE-FRAME ERRORS. FOLLOWING THE IMPLEMENTATION OF THE PROTOCOL, NO PATIENT (0%) EXPERIENCED A ROBOT-RELATED COMPLICATION AMONG 290 CASES INVOLVING 2,030 SCREWS PLACED WITH ROBOTIC ASSISTANCE, REPRESENTING A SIGNIFICANT REDUCTION (P = 0.01). THE NUMBER OF PATIENTS WITH OPEN SURGERY (VERSUS MINIMALLY INVASIVE SURGERY) DID NOT DIFFER SIGNIFICANTLY BETWEEN THE PRE-PROTOCOL (132 PATIENTS, 50%) AND POST-PROTOCOL (143 PATIENTS, 49.3%) GROUPS. THE MEAN NUMBER OF INSTRUMENTED LEVELS PER PATIENT POST-PROTOCOL WAS 3.3 ± 2.1. NON-ROBOT-RELATED COMPLICATION RATES WERE SIMILAR POST-PROTOCOL (19.7%) VERSUS PRE-PROTOCOL (26.1%) (P > 0.05). NOTABLY, POST-PROTOCOL, THERE WERE NO INSTANCES OF A PEDICLE BREACH WITH NEUROSTIMULATION OR ON POSTOPERATIVE IMAGING. CONCLUSIONS: FOLLOWING THE IMPLEMENTATION OF STANDARDIZED ROBOTIC SURGERY GUIDELINES, NO ROBOT-RELATED SCREW COMPLICATIONS OCCURRED IN A POST-PROTOCOL COHORT OF 290 PATIENTS. THIS STUDY UNDERSCORES THE IMPORTANCE OF PROTOCOL STANDARDIZATION, ALONGSIDE TECHNOLOGICAL ADVANCEMENTS, IN OPTIMIZING PATIENT SAFETY AND IMPROVING OUTCOMES IN RASS. WELL-DESIGNED INSTITUTIONAL PROTOCOLS MAY NOTABLY REDUCE ROBOTIC SURGERY COMPLICATIONS AND CAN BE A VALUABLE MODEL FOR OTHER INSTITUTIONS. LEVEL OF EVIDENCE: THERAPEUTIC LEVEL III. SEE INSTRUCTIONS FOR AUTHORS FOR A COMPLETE DESCRIPTION OF LEVELS OF EVIDENCE. REPORTED EVENT: FIVE HUNDRED AND FIFTY-FOUR PATIENTS UNDERWENT A SPINAL PROCEDURE. TWO HUNDRED AND SIXTY-FOUR UNDERWENT THE PROCEDURE PRIOR TO THE CREATION OF A PROCEDURE PROTOCOL, AND TWO HUNDRED AND NINETY UNDERWENT THE PROCEDURE AFTER THE PROTOCOL WAS INSTATED. DURING THE PRE-PROTOCOL PROCEDURES, THERE WERE SIX COMPLICATIONS RELATED TO THE GUIDANCE SYSTEM. THERE WAS ONE PATIENT WITH PERMANENT MOTOR DEFICIT, ONE PATIENT WITH DUROTOMY, ONE PATIENT, ONE PATIENT WITH SENSORY NERVE DAMAGE, AND THREE PATIENTS WITH MALPOSITIONED SCREWS THAT BREACHED THE MEDIAL PEDICLE WALL, WHICH REQUIRED REOPERATION. IN ONE CASE, THE REFERENCE FRAME WAS PLACED ON THE POSTERIOR SUPERIOR ILIAC SPINE CONTRIBUTED TO A SCREW MISPOSITIONING AT T10-T11. HALF OF THE SIX COMPLICATIONS WERE A RESULT OF A REFERENCE FRAME SHIFT ERROR. IT WAS ALSO NOTED THAT THERE WERE SIXTY-NINE COMPLICATIONS THAT WERE UNRELATED TO THE GUIDANCE SYSTEM, WHICH REQUIRED THIRTY-SEVEN REOPERATIONS. ADDITIONALLY, IN THE PRE-PROTOCOL PROCEDURES, THREE PATIENTS EXPERIENCED TEMPORARY NERVE INJURIES DUE TO MEDIALLY MALPOSITIONED SCREWS, ONE PATIENT EXPERIENCED NERVE ROOT DAMAGED DUE TO TAPPING, ANOTHER HAD SENSORY INJURY FROM DRILLING, AND THEN ANOTHER HAD DUROTOMY FROM SCREW MALPOSITION. DURING POST-PROTOCOL PROCEDURES, THERE WERE NO COMPLICATIONS ASSOCIATED WITH THE GUIDANCE SYSTEM. THERE FIFTY-SEVEN COMPLICATIONS THAT WERE UNRELATED TO THE GUIDANCE SYSTEM. THERE WERE FIVE GASTROINTESTINAL COMPLICATIONS, WHICH INCLUDED ILEUS, NAUSEA/DELAYED RETURN OF BOWEL FUNCTION, DEHYDRATION FROM NAUSEA OR VOMITING, AND SEVERE ABDOMINAL PAIN. THERE WERE TEN NEUROLOGICAL COMPLICATIONS, WHICH INCLUDED FOOT DROP, PERSISTENT RADICULOPATHY, RIGHT ILIOPSOAS WEAKNESS, QUADRICEPS WEAKNESS, DURAL TEAR, RIGHT HAND WEAKNESS, AND DISC REHERNIATION. THESE REQUIRED SEVEN REOPERATIONS. THERE WERE TWELVE INFECTIONS, INCLUDING WOUND INFECTION, URINARY TRACT INFECTION, SEPSIS, AND AN INFECTED ABSCESS. THESE REQUIRED FIVE REOPERATIONS. THERE WERE TWO PULMONARY COMPLICATIONS, WHICH WERE A BILATERAL PULMONARY EMBOLISM AND A PULMONARY EMBOLISM. THERE WERE EIGHTEEN CARDIOVASCULAR COMPLICATIONS, WHICH INCLUDED BLOOD LOSS ANEMIA, HYPOTENSION, NEW ONSET ATRIAL FIBRILLATION, DEEP VEIN THROMBOSIS, HEMATOMA, HYDROSTATIC ORTHOSTASIS, AND INFERIOR VENA CAVA INJURY. THIS RESULTED IN TWO REOPERATIONS. THERE WERE FOUR LONG TERM DEGENERATION COMPLICATIONS, WHICH INCLUDED IMPLANT FAILURE, PSEUDARTHROSIS, AND PROXIMAL JUNCTIONAL FAILURE. ALL LONG-TERM COMPLICATIONS REQUIRED REOPERATION. THERE WERE SIX OTHER COMPLICATIONS IDENTIFIED, WHICH INCLUDED L1-L2 AND T11-T12 SPONDYLOLYSIS, CONCERN FOR METAL ALLERGY, ACUTE-ON-CHRONIC HYPONATREMIA WITH NAUSEA OR VOMITING, SUSTAINED LEFT L5 PEDICLE FRACTURE, RETROGRADE EJACULATION, RETROPERITONEAL FLUID C OLLECTION WITH ILEUS, PERSISTENT ANTERIOR THIGH PAIN, AND QUADRICEPS WEAKNESS. THESE REQUIRED FOUR REOPERATIONS. ADDITIONALLY, IT WAS INDICATED THAT THERE WAS ONE SCREW THAT DEVIATED, BUT DUE TO THE PROTOCOL IT WAS IDENTIFIED AND REVISED PRIOR TO THE PROCEDURE ENDING. SEE ATTACHED LITERATURE ARTICLE." }, { "mdr_text_key": "394019494", "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 MEAN 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 NOT 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. 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. E050303 - PULMONARY EMBOLISM E0301 - ANEMIA E060102 - ATRIAL FIBRILLATION E051101 - GREAT VESSEL PERFORATION E120202 - HYPONATREMIA E0123 - SENSORY NERVE DAMAGE E0126 - PERSISTENT RADICULOPATHY E2401 - ILEUS, DISC REHERNIATION, IMPLANT FAILURE, PSEUDARTHROSIS, PROXIMAL JUNCTIONAL FAILURE, RETROGRADE EJACULATION, RETROPERITONEAL FLUID COLLECTION WITH ILEUS E0139 - FOOT DROP E0144 - DURAL TEAR E0306 - SEPSIS E0402 - METAL ALLERGY E0505 - HEMATOMA E0514 - DVT E1020 - NAUSEA E1032 - VOMITING E1310 - URINARY TRACT INFECTION E1603 - PEDICLE STRESS FRACTURE E1621 - RIGHT ILIOPSOAS WEAKNESS, QUADRICEPS WEAKNESS, RIGHT HAND WEAKNESS E1906 - INFECTED ABSCESS E2115 - WOUND INFECTION E2321 - HYPO TENSION E2330 - PAIN 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": "55112", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }