{ "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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WE DECIDED TO BACK OUT SCREW. THE SCREW WAS FIGHTING US. THERE WAS A STABILIZER FAILURE. THE SURGEON REMOVED POWER BLOCK AND USED T. WE STILL COULDN'T BACK OUT. WE NOTICED STAR TIP OF CUP DRIVER LODGED INTO THE FEMALE STAR OF SCREW. WE REMOVED ROBOT FROM FIELD. WE TOOK AN X-RAY AND THE L4 WAS LOW AND MEDIAL AND NOT IN THE PLANNED TRAJECTORY. THE SURGEON TESTED DRB RIGIDITY WITH FINGERS AND IT WAS COMPLETELY OUT OF BONE. THE SURGEON PROCEEDED TO REMOVE SCREW VIA DRILLING AROUND IT. THE SCREW WAS REMOVED. WE PROCEEDED WITH LAMI/DECOMPRESSION. WE PLACED SCREWS NON ROBOTICALLY POST DECOMPRESSION." }, { "mdr_text_key": "388394466", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. IT WAS REPORTED THAT SCREWS WERE MISPLACED AT L3-R AND L4-R. CASE LOGS WERE NOT PROVIDED, SO A FORMAL INVESTIGATION COULD NOT BE COMPLETED. HOWEVER, THE GLOBUS MEDICAL REPRESENTATIVE REPORTED THAT THE DYNAMIC REFERENCE BASE (DRB) HAD LOST PURCHASE IN THE BONE DURING THE PROCEDURE. THIS CAN LEAD TO A REGISTRATION SHIFT OR DYNAMIC REFERENCE BASE (DRB) SHIFT. BOTH REGISTRATION AND DRB SHIFTS CAN RESULT IN A LOSS OF NAVIGATIONAL INTEGRITY. AFTER THE REGISTRATION HAS BEEN COMPLETED, IT IS RECOMMENDED TO PERFORM A LANDMARK CHECK OR VERIFICATION TO ENSURE THAT THE REGISTRATION WAS SUCCESSFULLY CALCULATED . USING THE NAVIGATED VERIFICATION PROBE, TOUCH AN ANATOMICAL LANDMARK AND VERIFY THAT THE CORRESPONDING LOCATION IS SHOWN ON THE SYSTEM MONITOR. ULTIMATELY, THE USER OPTED TO REPLACE THE IMPLANTS AT L3-R AND L4-R USING TRADITIONAL METHODS AND THE CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT. THERE ARE NO ASSOCIATED WORK ORDER OR PART RETURNS. THE OBSERVED OVERALL RISK LEVEL IS LOW, WHICH MATCHES THE OBSERVED ANTICIPATED RISK LEVEL; THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED. 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": "" } ] }