{ "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": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MR.", "manufacturer_contact_state": "PA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "AUDUBON", "manufacturer_contact_address_1": "2560 GENERAL ARMISTEAD AVENUE", "manufacturer_contact_pcity": "61093018", "event_type": "Injury", "report_number": "3004142400-2024-00528", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20250129", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20231115", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "6109301800", "noe_summarized": "1", "manufacturer_contact_l_name": "PAUL", "source_type": [ "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "19403", "manufacturer_g1_state": "PA", "reporter_country_code": "US", "manufacturer_contact_area_code": "610", "date_added": "20250129", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "632395", "implant_date_year": "2023", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20250129", "brand_name": "EXCELSIUS GPS", "generic_name": "SYSTEM, EXCELSIUS GPS, 120V", "manufacturer_d_name": "GLOBUS MEDICAL, INC.", "manufacturer_d_address_1": "2560 GENERAL ARMISTEAD AVENUE", "manufacturer_d_address_2": "", "manufacturer_d_city": "AUDUBON", "manufacturer_d_state": "PA", "manufacturer_d_zip_code": "19403", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "19403", "device_operator": "HEALTH PROFESSIONAL", "model_number": "6143.1001", "catalog_number": "", "lot_number": "GPS-0158", "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": "00889095481297", "udi_public": "00889095481297", "openfda": { "device_name": "Orthopedic Stereotaxic Instrument", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ], "product_problems": [ "Human-Device Interface Problem", "Human-Device Interface Problem" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250825", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "6109", "patient": [ { "patient_sequence_number": "1", "date_received": "20250129", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury", "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20250128", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "21263245", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20250127", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "19403", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "GLOBUS MEDICAL, INC.", "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": "362388454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THE CASE WAS AN L4-S1 ALIF 360 USING HEDRON IA AND CREO ONE HARDWARE. THERE WAS NO PRIOR HARDWARE IN THE PATIENT. THE EGPS WORKFLOW WAS INTRA-OP CT. THE EGPS IS RUNNING SOFTWARE VERSION 1_1R3. THE PATIENT WAS POSITIONED PRONE FOR THE POSTERIOR PORTION AND THE CAMERA WAS POSITIONED AT THE FOOT OF THE BED. AN O-ARM WAS USED FOR IMAGING AND REGISTRATION. DR. (B)(6) PLACED THE DRB AT RIGHT PSIS WITH THE LOW-PROFILE QUATTRO SPIKE AND SURVEILLANCE MARKER AT LEFT PSIS. SURVEILLANCE WAS REGISTERED PRIOR TO THE ICT BEING POSITIONED ON THE QUATTRO SPIKE. THE ICT WAS POSITIONED, THE BED WAS RAISED, AND THE SURGICAL SNAPSHOT WAS TAKEN. THE O-ARM SPIN WAS ACQUIRED AND TRANSFERRED SUCCESSFULLY TO EGPS VIA ETHERNET. ALL 7 FIDUCIALS WERE CAPTURED SUCCESSFULLY, AND THE REGISTRATION FIT WAS DOWN ON GREEN. DR. (B)(6) PERFORMED LANDMARK CHECKS ON THE ICT FIDUCIALS AS WELL AS DOWN THE LOW-PROFILE QUATTRO SPIKE. NAVIGATION APPEARED TO EVERYONE IN THE ROOM TO BE ACCEPTABLE AND OF HIGH QUALITY. FOLLOWING PERCUTANEOUS PLACEMENT OF ALL SCREWS THROUGH BILATERAL WILTSY INCISIONS, A POST-OP REGISTRATION O-ARM SPIN WAS ACQUIRED. DR. (B)(6) DECIDED TO DO THIS PRIOR TO LOCKING THE CONSTRUCT DOWN AS HE QUESTIONED THE PLACEMENT OF THE L5R AND S1L SCREWS. THE CONFIRMATION SPIN ALSO REGISTERED IN THE SAME SUCCESSFUL MANNER. UPON REVIEW OF THE PLACED SCREWS, DR. (B)(6) BELIEVED THERE WAS A LATERAL SHIFT AT L5 (ALTHOUGH BOTH SCREWS WERE CONSIDERED \"SAFE\") AND THE S1L SCREW WAS TOO INFERIOR FOR COMFORT. WE USED THE NEW REGISTRATION TO REPLACE THE S1L SCREW UNDER A NEW TRAJECTORY. CONFIRMATION IMAGES TAKEN WITH A C-ARM SHOWED THE REPLACED S1L SCREW TO BE PLACED ACCURATELY AND TO PLAN. WHAT IS IN QUESTION IS IF THERE WAS A SHIFT DURING REGISTRATION AND ICT DETECTION OR IF THE SCREW PLACEMENT WAS A RESULT OF OTHER FACTORS SUCH AS PLANNING AND SKIVING." }, { "mdr_text_key": "362388455", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS IS BEING REPORTED FOR A PROBLEM FOUND EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE USER OF A POSSIBLE SHIFT OF THE ICT DURING REGISTRATION TRANSFER. IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK BEFORE PROCEEDING. THE USER CLEARED THE WARNING AND PROCEEDED WITH NAVIGATION. DURING THE BONE PREP WORK FOR THE PLACEMENT IMPLANTS, THE SOFTWARE DETECTED AND ALERTED THE USER OF EXCESSIVE DEFLECTION FORCES ON THE LOAD CELL. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE SOFTWARE CORRECTLY DETECTED THE FORCE AND ALERTED THE USER OF IT. THE USER REPORTED WAS REPLACED INTRA-OPERATIVELY, NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. THE SEVERITY IS OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND THERE IS NO FURTHER INVESTIGATION REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "2560 GENERAL ARMISTEAD AVENUE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "19403", "manufacturer_contact_exchange": "610", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }