Additional procodes kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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It was reported that on (b)(6) 2019, patient underwent t2-t12 instrumented fusion for idiopathic scoliosos.The following screws, rods and hooks were placed: left side: t2 laminar 8 mm wide blade hook, t3 4.35 x 35 verse, t4 5.0x 35 verse, t5 skip, t65.0 x 40 verse, t7 skip, t8 5.0 x 40 verse, t9 5.0 x 40 verse, t10 5.0 x 40 verse, t11 6.0 x 40 and t12 6.0 x 40.Right side: t2 pedicle up going hook expedium, t3 skip, t4 pedicle up going hook expedium, t5 4.35 x 35 verse, t6 skip, t7 5.0 x 35 verse, t8 skip, t9 6.0 x 40 verse, t10 skip, t11 6.0 x 40 verse and t12 6.0 x 40 verse.Two 5.5 x 480 cocr rods were cut and placed with correction keys and regular locking caps for hooks.Correction keys were locked on the concave side to create mono screws on the left side.Upon removing the right side the patient lost ssep¿s (somatosensory evoked potential) and motors to lower extremities.All the rods were removed.Signals did not come back.Wake up test performed and slight movement of lower extremity but marginal.Images are taken to confirm accurate screw placement and all screws locked well placed.All screws were removed and pedicles were stimulated with a probe.No responses were seen in any pedicles to stimulation.They began to close and wake up the patient.Lower extremities tested with prick test upon awakening.No sensations below upper quad areas bilaterally.Patient being transferred for mri imaging to assess an ischemic event.Patient was closed after osteotomies and removal of instrumentation leaving the outcome incomplete barring sensory loss of both ssep¿s and motors in lower extremities.Implants were removed and patient was woken up to assess issue and prevent further potential issues.Sensation was minimal at that time to prick testing the procedure outcome was incomplete.The patient hasn¿t been much positive improvement in sensory ability.As of (b)(6) 2019 the patient was getting tingling in lower extremities.(b)(4).
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