{ "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": "3004142400-2023-00188", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20240229", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20231026", "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": "20240229", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "896956", "implant_date_year": "", "date_removed_year": "2023", "serviced_by_3rd_party_flag": "U", "date_received": "20240229", "brand_name": "EXCELSIUS", "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-0321", "other_id_number": "", "device_availability": "No", "device_report_product_code": "OLO", "device_age_text": "", "device_evaluated_by_manufacturer": "R", "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": [ "Improper or Incorrect Procedure or Method", "Improper or Incorrect Procedure or Method" ], "reporter_state_code": "PA", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20250819", "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": "20240229", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "75 YR", "patient_sex": "Male", "patient_weight": "", "patient_ethnicity": "", "patient_race": "White", "patient_problems": [ "Insufficient Information", "Insufficient Information" ] } ], "distributor_city": "", "date_report": "20240228", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "18809674", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20231026", "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": "336581884", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS REPORT IS BEING RESUBMITTED FOR AN INCIDENT THAT OCCURRED EARLIER. INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE PURPOSE OF THIS INVESTIGATION IS TO EVALUATE THE RISK ASSOCIATED WITH THE IDENTIFIED FAILURE MODE OF MISPLACED IMPLANTS FOR EXCELSIUS GPS. INVESTIGATION OF THE CASE LOGS REVEALED THAT SKIVING IS A CONTRIBUTING FACTOR TO THE MISPLACEMENT OF SCREWS; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE CASE LOGS. THE SOFTWARE DETECTED EXCESSIVE FORCES ON THE LOAD CELL DURING BONE WORK FOR L4-L AND L5-L. THIS IS THE RESULT OF SKIVING FORCES DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. THE SOFTWARE CORRECTLY DETECTED THE FORCE AND ALERTED THE USER. SKIVING CAN LEAD TO THE MISPLACEMENT OF SCREWS. THE DYNAMIC REFERENCE BASE IN RELATION TO THIS CASE WAS RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE WAS TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "336581885", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT A SCREW USING THE EXCELSIUS GPS SYSTEM WAS MISPLACED INTRA-OPERATIVELY CAUSING A LARGE BLEED." } ], "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": "" } ] }