{ "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. 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THE SCREW WAS REMOVED AND REPLACED." }, { "mdr_text_key": "394161726", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. NO DETERMINATIONS COULD BE MADE AS TO THE CAUSE OF THE REPORTED ISSUE." }, { "mdr_text_key": "401364453", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "NO CASE LOGS WERE SUBMITTED, SO NO FORMAL INVESTIGATION COULD BE PERFORMED. HOWEVER, IT WAS REPORTED BY A GLOBUS MEDICAL REPRESENTATIVE THAT DURING THE PROCEDURE, ONE IMPLANT WAS MISPLACED AND THEY WERE EXPERIENCING A LOSS OF NAVIGATIONAL INTEGRITY. ONE IMPLANT HAVING NAVIGATIONAL INTEGRITY ISSUES CAN BE INDICATIVE OF EXCESSIVE DEFLECTION FORCES, OR SKIVING. SKIVING CAN LEAD TO THE MISPLACEMENT OF IMPLANTS. ULTIMATELY, THE USER OPTED TO REPLACE THE MISPLACED IMPLANT INTRA-OPERATIVELY WITH NO ADVERSE EFFECT TO THE PATIENT REPORTED. THIS EVALUATION HAS BEEN COMPLETED WITHOUT 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 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 FOLLOWING SECTIONS WERE UPDATED FOR THIS SUPPLEMENTAL REPORT: B4, G3, G6, H2, H3, H6, H10." }, { "mdr_text_key": "401364454", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING AN EXCELSIUS GPS SURGERY THERE WAS A L4 ACCURACY ISSUE WITH PLACEMENT OF THE SCREW. THE SCREW WAS REMOVED AND REPLACED." } ], "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": "03/25/2026" } ] }