These fields have been corrected following receipt of additional communication from the field: b1, b2, b5, h1.The device remains implanted and is unavailable for evaluation.Device history record review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Additional correspondence with the field representative: "the doctor misunderstood that they probably did not deploy a blocker in screw head and they inserted a new blocker on the top of the blocker that had already been in place." from mantis surgical technique: improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.The most likely root cause of the reported event is user error.
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