It was reported that a revision surgery was performed to replace a 2-level mobi-c construct due to persistent and worsening pain from the neck into the lue down into the fingers of the left hand.According to imaging, there was severe stenosis bilaterally at c567 levels and x-rays show clear implant malposition.The patient was revised with implant removal, revision decompression with uncinate resection, and placement of competitive implants.This patient had immediate relief of their arm pain and immediate return of full range of motion.This is report one of two for this event.
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Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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