{ "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": "3004142400-2026-00063", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20260408", "manufacturer_address_2": "", "pma_pmn_number": "K171651", "date_of_event": "20260312", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "19403", "reporter_occupation_code": "PHYSICIAN", "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": "", "date_added": "20260408", "manufacturer_contact_f_name": "DANIEL", "previous_use_code": "R", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "876509", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20260408", "brand_name": "EXCELSIUS GPS", "generic_name": "ROBOT, SURGICAL, NAVIGATION UNIT", "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-0234", "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": "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" ], "reporter_state_code": "NC", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260501", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260408", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Spinal Column Injury" ] } ], "distributor_city": "", "date_report": "20260408", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "AUDUBON", "mdr_report_key": "24817407", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20260312", "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": "397790723", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY, WE DID A INTRA-OP SPIN WITH DRB IN PSIS WITH OPEN INCISION, DOING A PARTIAL REVISION AND ADDING A LEVEL ABOVE AT L2. THE SURGEON REMOVED SCREWS AT L3 LEFT AND L4 LEFT BEFORE SPIN. WE DID OUT INTRA-OP SPIN WITH E3D AND THEN PLANNED SCREWS. THE PATIENT HAD SOME SCOLIOSIS AT THE LOWER LEVELS AND WE PLANNED THE NEW SCREW TRAJECTORIES A LITTLE MORE LATERAL. ALL OF THE SCREWS WERE PLACED CORRECTLY EXCEPT L4 LEFT (LAST SCREW) WHICH ENDED UP BEING DEEP. WE CHECKED NAV BEFORE PLACING SCREWS AND EVERYTHING LOOKED CORRECT. AS WE WERE DOING LAST SCREW, THE REP TOLD SURGEON THAT IT LOOKED LIKE THEY WERE DOWN EVEN THOUGH THEY DID NOT RECEIVE \"CHECK MARK\" FOR IMPLANT PLACED. THE SURGEON PROCEEDED TO CONTINUE TWISTING SCREW AND UP ON X-RAY THE SCREW WAS DEEP. THE REP BELIEVES THAT THE SCREW FELL INTO THE OLD HOLE TRAJECTORY AND THEN THEY OVER TIGHTENED SCREW." }, { "mdr_text_key": "397790724", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THAT AN IMPLANT WAS MISPLACED AT L4-L. AN INVESTIGATION INTO THE PROVIDED CASE LOGS REVEALED THE ROOT CAUSE FOR THE MISPLACED IMPLANT WAS EXCESSIVE DEFLECTION FORCES, OR SKIVING. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. THE SOFTWARE CORRECTLY DETECTED AND ALERTED THE USER OF HIGH DEFLECTION FORCES PRESENT ON THE LOAD CELL DURING BONE WORK. THIS EXCESSIVE FORCE PRESENT ON THE LOADCELL IS LIKELY THE RESULT OF INSTRUMENT SKIVING THAT WAS DETECTED WHILE A TOOL IS INSERTED INTO THE END EFFECTOR. ULTIMATELY, THE USER OPTED TO REPLACE THE MISPLACED IMPLANT USING TRADITIONAL METHODS WITH NO ADVERSE EFFECT TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED VIA ASSOCIATED CASE LOGS AND THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE SEVERITY OBSERVED DID NOT EXCEED THE ANTICIPATED SEVERITY. THE OBSERVED OVERALL RISK LEVEL IS BELOW 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": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }