Analysis of the clinical exports and logs was completed.During the analysis, the clinical export data file was thoroughly inspected.The export file was generated by the mazor x system, and includes records of all the data that was used and generated by the system during the case, including but not limited to the intra-operative scans, preoperative planning, procedure actions that were executed, and the log text file.The log text file is a chronologic documentation of the software during operation, including trajectories sent by the system, star marker (sm) recognition accuracy, etc.The log file was examined with respect to all intraoperative fluoro images to inspect and understand procedure workflow.O-arm images were checked, star marker recognition was attempted with the registration, star marker images utilized during the operation on a mazor x r d workstation.Analysis reviewed the planning made for the case.A planning of l4-l5 tlif procedure was done for the specific segment.It seems that the trajectories planned in both l4 and l5 vertebras are very proud and placed in anatomical areas which have high chance of skiving potential.The nature of the deviation was reviewed.It was reported that during a t5-l4 tlif procedure, after placing the screws and doing a spin - l4 trajectories were thought to be slightly lateral and the patient experienced right side back pain.Observing the planning of l4 and l5 from axial views, it is shown that the planned trajectories are very proud (wide) and their location is sub optimal in an anatomical area with high potential for skiving.Analysis reviewed all available information and concluded the root cause of the deviations is sub-optimal planning, resulted in skiving potential for both l4 and l5 vertebras.If information is provided in the future, a supplemental report will be issued.
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