A complete manufacturing records review conducted by intrinsic showed that the product was manufactured to specification.The provided ct imaging showed clear evidence of the anchor head fracture.Based on the immediate post-operative image, the barricaid device was well-implanted.A comparison of the immediate post-op image and the image with the fractured anchor shows a marked decrease in posterior disc height.This decrease in disc height likely brought the opposing endplate in contact with the anchor head, providing the driving force for the eventual fracture.Anchor fracture is a known inherent risk identified in the device ifu with occurrence rates lower than those stated in our device ifu which are determined and based upon the pivotal superiority study.Note: this mdr is being filed since intrinsic has identified 12 complaints that originated outside the us (ous) between feb 2019 and may 2020 that are deemed to be reportable in the us.Hence this mdr report is past 30 days from the adverse event occurrence date.
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