{ "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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INVESTIGATION REVEALED THAT THERE WAS NO SYSTEM MALFUNCTION. THE CASE LOGS SHOWED THAT THE SYSTEM DETECTED AND NOTIFIED THE USER OF A DRB SHIFT. AS THIS SHIFT EXCEEDED THE ACCEPTED TOLERANCE FOR DRB MOVEMENT OR SURVEILLANCE MARKER MOVEMENT, THIS IS LIKELY THE CAUSE FOR THE SCREWS BEING SLIGHTLY OFF PLAN. AFTER A \"POSSIBLE SHIFT OF THE DRB\" WARNING IS PRESENTED, IT IS RECOMMENDED THAT THE USER PERFORMS AN ANATOMICAL LANDMARK CHECK. IF THE ANATOMICAL LANDMARK CHECK IS INACCURATE, THE USER CAN REREGISTER. THE USER CAN REREGISTER THE PATIENT BY SELECTING THE \"EXTEND CASE OPTION\" IN THE UPPER RIGHT-HAND CORNER OF THE SCREEN, USING THE LIFE-SAVER ICON. ULTIMATELY, THIS CASE WAS COMPLETED WITH NO REPORTED ADVERSE EFFECTS TO PATIENT. THE OBSERVED OVERALL RISK LEVEL IS LOW WHICH DOES NOT EXCEED THE OBSERVED ANTICIPATED RISK LEVEL. THEREFORE, THE OVERALL RISK OF THE SYSTEM HAS BEEN MAINTAINED AND NO FURTHER INVESTIGATION IS REQUIRED. THE CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "362187308", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "PROCEDURE WAS A L3-5 OPEN/MIDLINE RIGHT TLIF USING A PRE-OP CT WORKFLOW. 9' FLOURO FIXTURE WAS USED WITH A OEC 9900 ELITE C ARM. SURGEON IDENTIFIED A MEDIAL BREACH OF THE RIGHT L3 SCREW." } ], "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": "" } ] }