No revision surgery is planned.Surgeon has elected to monitor patient at this time.There is no evidence that the device malfunctioned.It is unknown what caused the dysesthesia in the legs.It is unknown if the patient followed post-operative instructions.Patient should be cautioned against early weight bearing and premature ambulation that could lead to loosening and/or failure of the fixators or loss of reduction.It is unknown which concomitant device (if any) or part of the interbody fusion surgical procedure (if any) has caused or contributed to this event, and no conclusion can be drawn.Labeling, warning and precautions: procedures involving bone grafting can produce highly variable results.Significant vascular or neurological impairment proximal to the graft site.Severe vascular or neurological disease.Metabolic or systemic bone disorders that affect bone or wound healing.Severe degenerative bone disease.Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.It is not intended to replace or change standard procedures for treatment of bone defects involving bone grafting and fixation.Does not possess sufficient mechanical strength to support the reduction of a graft site prior to tissue in-growth.Therefore anatomical reduction and rigid fixation in all planes should be obtained independently.
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On (b)(6) 2016 a (b)(6) year old female underwent a one level transforaminal lumbar interbody fusion at l5-s1 involving cascadia interbody (k2m inc.), posterior fixation, autograft and bone void grafting biologic devices.First follow up, seven to ten days postoperatively, the patient reported dysesthesia in their leg.Surgeon reported there was no pedicle breach, no nerve root swelling and no emg changes.A six week follow up, the surgeon determined the patient was progressing, but continuing to experience pain in the leg.At this time, no medical intervention/revision surgery is planned.Surgeon will continue to monitor patient improvement.
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