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 re-evaluation, the surgeon discovered that a pedicle screw broke just below the head on the patient's 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 chose 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 1 of 27 for complaint (b)(4).
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Device was used for treatment, not diagnosis.Date of event: actual event date not known.Common device name: additional product code for this report includes mni.Implant date: implant on unknown date - approx (b)(6) 2012, (b)(6) ago.Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.Placeholder.
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