Investigation summary & conclusion: review of dhr did not identify and deviations or abnormalities.Review of complaint history did not identify any additional complaints on this item for loss of motors.The 20adan spine assembly a1 cad file was downloaded and inspected.Visual inspection of the guide identified 6 patient contacting locations (2 fixation screws, 2 legs, and 2 distal extensions) to guide 3 screws (t7 l&r and t7 l hemi).Inspection of the planned trajectories identified that both t7 screws were against the medial wall of the pedicle but not breaching.All screws were planned in an acceptable location per the work order fulfillment process.Inspection of the cad files for the guides & screws found that the guide was conforming.The bone model and guide were manufactured using an internal printed and inspected.The parts were able to pass relevant manufacturing inspection checks (ff-psg-507) to stability and trajectory.No evidence of nonconformance identified.Loss of motors may be due to a variety of different reasons.Based on this, a root cause for the loss of motors cannot be definitively concluded.Based on information received from the customer, the surgeon did not believe he had seated the guide appropriately and medially breached.Without radiographs, a medial breach cannot be confirmed.All evidence indicated that the guide provided to the customer was conforming.It cannot be confirmed or refuted that the guide caused or contributed to the patient injury.
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