{ "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": "3005075696-2024-00061", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20240522", "manufacturer_address_2": "", "pma_pmn_number": "K182077", "date_of_event": "20240331", "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": "20240522", "manufacturer_contact_f_name": "GLEN", "device_date_of_manufacturer": "20190320", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "1609771", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20240522", "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": "DA", "device_evaluated_by_manufacturer": "N", "combination_product_flag": "N", "udi_di": "07290109183213", "udi_public": "07290109183213", "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": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/22/2024", "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": "20240522", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other", " R", " L" ], "patient_age": "15 YR", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Intracranial Hemorrhage", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Unspecified Tissue Injury", "Insufficient Information", "Intracranial Hemorrhage", "Post Operative Wound Infection", "Unspecified Nervous System Problem", "Unspecified Tissue Injury", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240523", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "IS", "manufacturer_contact_city": "MINNEAPOLIS", "mdr_report_key": "19371817", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20240501", "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": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "343101075", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "WIDMANN, R. F., WISCH, J. L., TRACEY, O. C., ZUCKER, C. P., FEDDEMA, T., MILLER, F., LINDEN, G. S., ERICKSON, M., & HEYER, J. H. (2024). ANALYSIS OF 5,070 CONSECUTIVE PEDICLE SCREWS PLACED UTILIZING ROBOTICALLY ASSISTED SURGICAL NAVIGATION IN 334 PATIENTS BY EXPERIENCED PEDIATRIC SPINE DEFORMITY SURGEONS: SURGICAL SAFETY AND EARLY PERIOPERATIVE COMPLICATIONS IN PEDIATRIC POSTERIOR SPINAL FUSION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-024-00854-7 PURPOSE: THIS STUDY EVALUATES THE INTRAOPERATIVE AND SHORT-TERM COMPLICATIONS ASSOCIATED WITH ROBOTICALLY ASSISTED PEDICLE SCREW PLA CEMENT IN PEDIATRIC POSTERIOR SPINAL FUSION (PSF) FROM THREE SURGEONS AT TWO DIFERENT INSTITUTIONS. METHODS: WE RETROSPECTIVELY REVIEWED 334 PEDIATRIC PATIENTS WHO UNDERWENT PSF WITH ROBOTIC-ASSISTED NAVIGATION AT 2 INSTITUTIONS OVER 3 YEARS (2020¿2022). FIVE THOUSAND SEVENTY ROBOTICALLY PLACED SCREWS WERE EVALUATED. DATA COLLECTION FOCUSED ON INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS WITH MINIMUM 30-DAY FOLLOW-UP. PATIENTS UNDERGOING REVISION PROCEDURES WERE EXCLUDED. RESULTS: INTRAOPERATIVE COMPLICATIONS INCLUDED 1 DUROTOMY, 6 PATIENTS WITH NEUROMONITORING ALERTS NOT RELATED TO SCREW PLACEMENT, AND 62 SCREWS (1.2%) WITH DOCUMENTED PEDICLE BREACHES, ALL OF WHICH WERE REVISED AT TIME OF SURGERY. BYQUARTILE, PEDICLE BREACHES STATISTICALLY DECLINED FROM FRST QUARTILE TO FOURTH QUARTILE (1.8% VS. 0.56%, P< 0.05). NO BREACH WAS ASSOCIATED WITH NEUROMONITORING CHANGES OR NEUROLOGICAL SEQUELAE. NO SPINAL CORD OR VASCULAR INJURIES OCCURRED. SEVENTEEN POSTOPERATIVE COMPLICATIONS OCCURRED IN ELEVEN (3.3%) OF PATIENTS. THERE WERE FVE (1.5%) PATIENTS WITH UNPLANNED RETURN TO THE OPERATING ROOM. CONCLUSION: ROBOTICALLY ASSISTED PEDICLE SCREW PLACEMENT WAS SAFELY AND RELIABLY PERFORMED ON PEDIATRIC SPINAL DEFORMITY BY THREE SURGEONS ACROSS TWO CENTERS, DEMONSTRATING AN ACCEPTABLE SAFETY PROFLE AND LOW INCIDENCE OF UNPLANNED RETURN TO THE OPERATING ROOM. REPORTED EVENTS: THREE HUNDRED THIRTY FOUR PATIENTS UNDERWENT A PEDIATRIC POSTERIOR SPINAL FUSION TO ADDRESS A SPINAL DISORDER OR INJURY. IT WAS NOTED THAT THERE WERE SIXTY TWO SCREWS THAT BREACHED. FORTY NINE WERE MEDIAL, TEN WERE LATERAL, ONE WAS INFERIOR, AND TWO BREACHED IN SOME COMBINATION OF DIRECTIONS. ONE PATIENT UNDERWENT A DUROTOMY AT A DEPTH OF TWELVE MILLIMETERS. A DURALSEAL WAS USED TO REPAIR THE ISSUE. THERE WERE TWO DEEP INFECTIONS. FIVE NEUROGLIAL COMPLICATIONS WERE NOTED AS WELL. ALL FIVE WERE NOT RELATED TO SCREW PLACEMENT. OF THE FIVE COMPLICATIONS, THREE WERE PERIPHERAL NERVE COMPRESSION SENSORY INJURIES DUE TO PATIENT POSITIONING, ONE LUMBAR STRETCH INJURY DISTAL TO THE INSTRUMENT REGION IN A PATIENT WITH SCHEUERMANN'S KYPHOSIS, AND ONE POSTOPERATIVE HEMORRHAGIC STROKE THAT OCCURRED IN A PATIENT WITH CEREBRAL PALSY. IT WAS ALSO NOTED THAT THERE WAS ONE CARDIAC AND TWO PULMONARY COMPLICATIONS. TWO CASES OF DELAYED NONUNION WERE ALSO PROVIDED IN THE LITERATURE ARTICLE. FINALLY, THERE WERE FIVE UNPLANNED RETURNS TO THE OPERATING ROOM. TWO WERE DUE TO THE DEEP INFECTIONS PREVIOUSLY MENTIONED, ONE PATIENT HAD A DISTAL LUMBAR NONUNION REVISED THREE YEARS POSTOPERATIVELY, ONE PATIENT HAD AN UNRECOGNIZED SCREW PULL OUT, AND ONE PATIENT HAD LOSS OF ALL MOTOR EVOKED POTENTIAL(MEP) IN THE OPERATING ROOM. THE PATIENT WHO LOST ALL MEP HAD ALL THE IMPLANTS REMOVED, AND THE PROCEDURE ABORTED. THE PROCEDURE WAS COMPLETED ON ANOTHER DATE WHERE THE IMPLANTS WERE INSTALLED WITHOUT COMPLICATION." }, { "mdr_text_key": "343101079", "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 ONLINE 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. E2015 - DUROTOMY E0118 - HEMORRHAGIC STROKE E0139 - NEUROLOGICAL COMPLICATIONS E2115 - DEEP INFECTION E2401 - CARDIAC & PULMONARY COMPLICATION 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": "343190422", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "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": "05/23/2024" } ] }