It was reported that the patient was originally treated for a burst fracture of t12 about 18 months ago, exact date unknown.The patient had the click x construct implanted due to this fracture.Upon reevaluation, the surgeon discovered that a pedicle screw broke just the below the head on the patients left l2 disk which was confirmed by x-ray on an unknown date.It was reported that patient was feeling discomfort from the hardware prominence.Due to the fact that the fracture had healed the surgeon choose to remove all the hardware and the explant was done on (b)(6) 2014 with no issues.The product has not been returned for investigation and no further information was provided.This is report 23 of 27 for (b)(4).
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Device was used for treatment, not diagnosis.Actual event date not known.(b)(4).Implant on unknown date - approx (b)(6) 2012, 18 months ago.Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.
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