No product has been returned for evaluation nor were xrays provided to confirm the alleged event.As per reporter computerized tomography (ct) and magnetic resonance imaging (mri) images confirmed the screws were touching a nerve.It is unknown if fluoroscopy was used at time of procedure.Labeling review: warnings, cautions and precautions: potential risks identified with the use of this device system, which may require additional surgery, include neurological injury."careful preoperative planning and the use of intraoperative fluoroscopy/imaging should be utilized to help avoid spinal cord, vertebral artery, nerve root, and/or other injuries.".
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On (b)(6) 2019, patient underwent a posterior cervical spinal fusion procedure at c4/5/6 levels with no reported issue.On (b)(6) 2019, one day postoperative, the patient started to experience numbness in right upper limb.That same day the patient underwent a revision procedure where all screw sets and rods of right side at the c5 and c6 levels were removed along with a left side rod.New screws were implant on the c5 level but not c6.New screw set and rods were implanted on both sides at the c7 levels.
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