Visual, dimensional, functional inspection, and material analysis could not be performed as the device was not returned.The x-rays provided confirmed one of the screws implanted initially was too long; however, this was not visible on x-rays taken during the surgery.There were no complications during the initial surgery and, per what was reported, appropriate steps from the surgical technique were followed.The plate was inserted using a plate inserter, the surgeon checked if the plate was securely attached, final position of the plate was confirmed with x-rays, the plate was inserted after all 3 screws were in a desired position, and the screws wholes were prepared with an awl.Patient is not very active and did not experience a fall post- op.This was the surgeon¿s first case with an anchor l.The plausible root cause of the reported event could not be determined conclusively from the information provided.Per anchor l risk file, factors that may have contributed to the plate disengagement: high bmi: anchor l surgical technique (stg) indicates "an overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself".Implant not positioned ideally within the disc space.Incorrect implant size selected.Patient pathology.Deformed plate during insertion: stg indicated "minimize the number of plate.Deformations as repetitive deformations may jeopardize the integrity of the plate".Hospital did not return device.
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