(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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 via medwatch (b)(4), a young girl with severe adolescent idiopathic scoliosis presented for elective posterior spinal fusion and bone grafting of t4-l4 vertebrae, as well as, epidural catheter placement tat t6 and t12.The patient was transported to the or at 0739.Motor potentials were unable to be obtained from the start of the surgery.Two dimensional c-arm xrays were completed intra-op.No concerns were noted.The surgery was completed at 1457 without any challenges.A "wake up" test was performed per recommended guidelines to assess sensorimotor functioning in the absence of intra-op monitoring.Upon awaking, the patient was unable to move her feet.She was extubated and brought to the post anesthesia unit for full wake-up.She had sensation of her legs but was unable to move them.She had an emergent ct scan that showed 3 pedicle screws in the spinal canal.She was brought back to the or to have the screws removed.She continued to have incomplete paraplegia after surgery including a loss of bowel and bladder control.She was treated with decadron and ketorolac.She regained some movement in her left lower extremity and was reporting bladder fullness and the sensation to void.Last report is that the patient is at home walking with crutches, using a wheelchair when fatigued.Range of motion on her right lower extremity is nearly normal but still lacks strength.Her bladder control is improving, with less retention when voiding but straight catheterizations are still required.
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