Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, no adverse trends were identified.Initial report states that the left s2 screw set screw popped out [migrated] post-op.No images, x-rays, or products were received.As it is the job of the set screw to hold the screw in place and there are no alleged deficiencies with the screw, this device did not contribute to the event.Report #3005525032-2022-00012 has been filed to capture the set screw.
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