On (b)(6) 2020 patient developed progressive motor dysfunction, neurogenic bowel and bladder from a large thoracic disc herniation.Patient has chronic pain in the back, numbness in the legs since the surgery and episodic falling.Thoracic stenosis, disc degeneration, and stenosis requiring extension of her previous fusion up to t9 with new development of proximal junctional kyphosis (above the fusion t8-t9), back pain, and persistent urinary dysfunction.The surgeon reviewed the mri at the (b)(6) 2021 visit which failed to reveal any surgical lesions.On (b)(6) 2021 patient was in the emergency room.Mri noted post operative changes with a small disc budge at t5-t6 and t8-t9 focal kyphosis.T9 pedicle screw appears to have migrated and bein the foramen.Since the initial details were received, there has been no further information provded that would contribute to the determination of the root cause.If relevant information is later identified, the record will be reopened and updated.Review of labeling: possible adverse events: loosening of spinal fixation implants may occur due to, latent infection, and/or premature loading, possibly resulting in bone erosion, migration or pain.
|
On (b)(6) 2020 patient developed progressive motor dysfunction, neurogenic bowel and bladder from a large thoracic disc herniation.Patient has chronic pain in the back, numbness in the legs since the surgery and episodic falling.Thoracic stenosis, disc degeneration, and stenosis requiring extension of her previous fusion up to t9 with new development of proximal junctional kyphosis (above the fusion t8-t9), back pain, and persistent urinary dysfunction.The surgeon reviewed the mri at the (b)(6) 2021 visit which failed to reveal any surgical lesions.On (b)(6) 2021 patient was in the emergency room.Mri noted post operative changes with a small disc budge at t5-t6 and t8-t9 focal kyphosis.T9 pedicle screw appears to have migrated and bein the foramen.
|