{ "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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(B)(4). THOUGH THE PROCEDURE USING THE SUBJECTED DEVICE WAS PERFORMED ON (B)(6) 2018, IT WAS REPORTED TO THE COMPANY ON (B)(6) 2019, AS IT WAS IDENTIFIED BY THE SURGEON ONLY DURING THE FOLLOW-UP VISIT, OCCURRED TWO MONTHS AFTER THE ACTUAL PROCEDURE. THEREFORE, THE COMPANY IS IN COMPLIANCE TO THE 30 DAYS REPORTING REQUIREMENT." }, { "mdr_text_key": "134578900", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "DURING THE L3-L5 TLIF PROCEDURE, PERFORMED ON (B)(6) 2018, ALL TRAJECTORIES WERE CONFIRMED TO BE ACCURATE, AND NO SPECIAL ISSUES OCCURRED. HOWEVER, IN FOLLOW-UP EXAMINATION PERFORMED AFTER 2 MONTHS (COMPANY AWARENESS DATE (B)(6) 2019), THE SURGEON HAS NOTICED THAT SCREWS HAVE DEVIATED LATERALLY, REQUIRING ADDITIONAL REVISION SURGERY FOR THEIR CORRECTION. 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