{ "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 CASE WAS COMPLETED WITH NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THE COMPLAINT DESCRIPTION STATES THAT THERE WAS CONSTANT DRB MOVEMENT THE RESET AS A RESULT. THE USER IS ALWAYS ADVISED TO VERIFY NAVIGATION INTEGRITY BY PERFORMING A LANDMARK CHECK, AND THE DESCRIPTION ALSO STATED THAT THE USER WENT AHEAD WITH THE PROCEDURE EVEN THOUGH THE LANDMARK CHECK FAILED. 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 CAUSE OF THE REPORTED ISSUE CAN BE TRACED TO USER TECHNIQUE." }, { "mdr_text_key": "400882560", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING A CASE WE PLACED A SP CLAMP ON S1 TO INSTRUMENT L5-S1 WITH FREEHAND NAVIGATION. DURING THE CASE, AT SEVERAL TIMES, THE DRB HAD SHIFTED DUE TO OVER-MOBILITY OF THE BODY- WE WERE ALERTED FROM WHAT WE VISUALLY SAW, AS WELL AS THE SM GOING RED. WE PERFORMED LANDMARK CHECKS THE FIRST TWO TIMES, AND SM WAS RESET ACCORDINGLY. AFTER A THIRD TIME, THE LANDMARK CHECK WAS OFF WITHOUT A DOUBT. AFTER SCREWS WERE PLACED (RIGHT SIDE ONLY), HE BELIEVED THAT L5 WAS PLACED LATERAL TO PLAN, AS WELL AS S1." } ], "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": "" } ] }