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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Catalog Number 7510400 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Cerebrospinal Fluid Leakage (1772); Dysphagia/ Odynophagia (1815); Hyperglycemia (1905); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Paralysis (1997); Scar Tissue (2060); Seroma (2069); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.
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Event Description
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It was reported that on an unknown date in (b)(6) 2014, rhbmp-2/acs was implanted in the patient.Post-op, rhbmp-2/acs bone graft caused inflammation and scar tissue to develop on patient's spine after she had several lumbar surgeries.Reportedly, the patient woke up after one surgical treatment that left her completely paralyzed.
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Manufacturer Narrative
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(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2010 patient underwent a fusion surgery.Post-op, reportedly, patient suffered with severe bodily injuries, paraplegia and intractable back and leg pain and her spinal nerves got injured.Patient underwent pain management treatment but nothing relieved her pain.Patient retired as post-op her ability to enjoy life has been significantly impaired.Patient has ambulation difficulties.Patient suffered with ectopic bone growth, inflammation and scar tissue.Patient was eventually paralyzed as a result of a surgery performed on (b)(6) 2015.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2010: preoperative diagnosis: status post multiple previous surgeries, now with non-union of l4-5 and l5-s1.The patient was essentially in severe and intractable pain due to the fact that she had transforaminal lumbar interbody fusion at l4-5 and l5-s1.It was decided to perform an anterior approach to l4-5 and l5-s1 to resolve these non-unions.Procedure performed: anterior lumbar interbody fusion, l4 through s1 with posterior spinal fusion l4 through s1 with hardware revision.As per op notes: ¿the posterolateral fusion was carried out with locally harvested bone graft and bone marrow aspirate.Rhbmp-2 was also used to the extreme fragility of the bone and the very difficult situation.¿ the patient also underwent following procedures: anterior exposure of lumbosacral spine for discectomy and fusion.Placement of two-levels preclude patches.Preoperative diagnosis: degenerative disc disease, lumbosacral spine.On (b)(6) 2010: the patient underwent x-ray of the chest due to shortness of breath.Impression: mediastinal widening is new since three days prior, possibly related to line placement.Persistent edema and cardiomegaly.On (b)(6) 2010: the patient underwent x-ray of the chest due to infection.Impression: fullness within the right paratracheal region, unchanged from the recent chest radiograph.Right subclavian catheter to the superior vena cava, unchanged.3.Apical pleural thickening on the right which appears slightly increased.On (b)(6) 2010 the patient underwent ct scan of the chest.Impression: bilateral small to moderate size pleural effusions, right greater than left with atelectasis.Underlying infiltrate cannot be excluded.Possible component of interstitial edema.On (b)(6) 2010: patient presented for follow up visit and still having some leg pain and shortness of breath.On (b)(6) 2010: patient underwent ct pulmonary angiogram due to chest pain and shortness of breath.Impression: no acute disease.She underwent ct of lumbar spine as well.Conclusion: status post removal of the l2-3 pedicle screws; the fusion at l2-3 appears solid.Exuberant ossification seen behind the left l3 pedicle tract; this is almost like an area of myositis.Disc device eccentric to the left at l3-4 projecting into the left l3-4 foramina, but probably does not impinge upon the l3 ganglia; there appears to be a solid fusion at l3-4.Laminectomy at l3, l4 and l5.Pseudomeningocele 10 x 4.5 cm, epicenter approximately l4.Pedicle screws at l4-5 and l5-s1 are in reasonable position; the disc devices are reasonable, although both are anterior.7.Moderate spurring in the left l5-s1 foramina that may just touch the left l5 ganglia.On (b)(6) 2010: patient presented for follow up visit with complaint of headache with pain in back of head.X-rays of cervical spine are unremarkable.On (b)(6) 2010: patient also underwent mri of the cervical spine due to headache and neck pain.Impression: minor degenerative changes noted throughout the cervical spine.No evidence of significant central canal or foraminal narrowing.Otherwise, unremarkable mri cervical spine.On (b)(6) 2010: patient presented for follow up visit with complaints of headache(posterior occipital going into back of head).Cervical mri was unremarkable.On (b)(6) 2010: the patient presented with bilateral headaches consistent with greater occipital neuralgia.She underwent bilateral greater occipital nerve root block steroid injection.The 6 mg celestone and 2 cc of xylocaine were injected without any complication or adverse event.On (b)(6) 2010: patient presented for follow up with complaints of headache and back pain.Her back is relatively sore.On (b)(6) 2010: the patient presented for physical therapy.Evaluation findings: tightness in the lower extremity musculature, especially the hamstrings and piriformis.Increased tone in the lumbar paraspinals and bilateral piriformis.Forward head posture with poor mobility of the ¿oa¿ and ¿aa¿ segments.Decreased core strength, especially in the lower abdominals.On (b)(6) 2010: the patient presented with postoperative head ache, lower lumbar and hip pain.On (b)(6) 2011: the patient presented for bilateral sacroiliac joint intra-articular steroid injections with 90% improvement on the left and only 20 % on the right.On (b)(6) 2011: patient presented for follow up visit and continues to have issue with headache.She is also having some back pain.Her x-rays seem to show a progressing fusion.Her cervical mri is reviewed which doesn¿t seem to have any significant neuro compressive lesion or other problem.On (b)(6) 2011 the patient underwent mri of the spine.Impression: posterior lumbar interbody fusion at l4-5 and l5-s1 with metallic hardware remaining in place.Laminectomy is demonstrated at l4 and l5.A large fluid collection is present within the dorsal lumbar soft tissue which likely represents a pseudomeningocele.Interbody fusion device at l3-4 appearing protrude into the left neural foramen.Clumping of the nerve roots is appreciated suggesting arachnoiditis.Grade 1 retrolisthesis of l1 that appears stable in flexion and extension.Mild circumferential disc bulge at l1-2 mildly impressing on the thecal sac.The disc bulge appears to decrease slightly during extension with no significant change in size during flexion.Bilateral facet arthrosis and mild left neural foraminal narrowing is seen.Mild right paracentral disc protrusion at l4-5 which contacts the thecal sac and produces moderate right neural foraminal narrowing.No significant change in protrusion size seen during flexion or extension.On (b)(6) 2011 the patient underwent ct scan of the lumbosacral spine.Impression: although prior images are not available, by report, slight increase in size of large posterior fluid collection within the soft tissues dorsal to the lumbosacral spine, which extends to the thecal sac at the l3 level and likely represents a pseudomingocele.Again seen are postoperative changes from l2 to s1 with removal of screws at l2-4 and placement of pedicle screws and interconnecting rods from l4-s1, which cause bean-hardening artifact somewhat limiting evaluation.Intervertebral disc spacer at l3-4 extends into the left neural foramen.Extensive bilateral facet hypertrophic changes in the lower lumbar spine.On (b)(6) 2011: patient presented for follow up visit with complaints of left sided buttock pain and pain to ischial tuberosity.Her ct scan was reviewed which shows a progressing fusion at l4-5 and l5-s1.There is no foraminal stenosis and no obvious reason for radicular buttock pain.On (b)(6) 2011: patient presented with chief complaint of hypertension, night sweats.Diagnoses: hypertension.Hyperglycemia.Night sweats.Dehydrator.On (b)(6) 2011: patient presented with following pre-op diagnosis: left l3-4 foraminal stenosis.Peridural fibrosis.Patient underwent following procedures: left l3-4 transit decompression nerve roots.Re-exploration laminectomy with resection of peridural fibrosis.No patient complications were reported as a result of the event.The patient underwent x rays of the lumbar spine.Impression: fluoroscopic localization without radiologist present.On (b)(6) 2011: the patient was pre-operatively diagnosed with lumbar radiculopathy and underwent selective nerve root block lumbar left l3 multiplanar fluoroscopy.The patient was also pre-operatively diagnosed with hardware re exploration l3-l4, decompression with laminectomy and underwent hardware re-exploration l3-l4, decompression with laminectomy.On (b)(6) 2011: the patient presented with severe left buttock, posterior thigh, calf, and anterior shin pain.The patient has had a fusion l3 to s1 in stages.On (b)(6) 2011: the patient presented with the following diagnoses: difficult walking.Lumbago.On (b)(6) 2011: the patient presented with the diagnoses of bursitis and hip trochanteric pain, and underwent bilateral trochanteric bursa injections under fluoro with 50% reduction of her pain.No patient complications were reported.On (b)(6) 2011: the patient presented for medical refill and follow up, with a known history of low back pain radiating to the lower left extremities felt to be secondary to sacroiliitis.The pain was getting more severe.Assessments: sacroiliitis, not elsewhere classified; lumbago; sciatica; encounter for long term (current) use of other medications; postsurgical arthrodesis status; displacement of lumbar intervertebral disc without myelopathy.On (b)(6) 2011 the patient underwent ct scan of the abdomen.Impression: stable left adrenal nodule.Large fluid collection posterior to the lumbar spine.Postoperative changes in the lower lumbar spine.On (b)(6) 2011 the patient underwent ct scan of the lumbar spine.Impression: lower lumbar hardware in good position.Largest pseudo meningocele possibly arising from the region of the left facetectomy at l3-4.The patient also underwent mri of the pelvis.Impression: no significant abnormality in the bony pelvis, sacrum, coccyx, presacral soft tissues or the sacral-sciatic notches.Prior lumbar spine surgery.A large hematoma or seroma in the posterior lumbar paraspinous soft tissue.On (b)(6) 2011: the patient presented with bilateral buttock pain and pain in the coccygeal area.The pain extended into the popliteal fossas.She had numbness of the middle three toes bilaterally.Symptoms were much worse with sitting.She had subjective weakness to both lower extremities, more prominently on the left side.She had 6 weeks of physical therapy with stretching and exercise which had been of very little benefit.Neurologic examination showed weakness of great toe extensors bilaterally.She had extremely tight hamstrings and her gait was very slow and antalgic.A ct scan of the lumber spine was reviewed in depth, which showed hardware and lateral fusion from l4 to the sacrum.There was evidence of the left side of screws having been placed at both l2 and l3.She had a decompression from l3 to the sacrum.No evidence for meningocele was observed in the ct image.The artifact made the ct image difficult to be interpreted.On (b)(6) 2011: the patient presented for a consultation of drainage of her pseudomeningocele.She also complained of deep pelvic pain, sudden electric-like sensation in both lower extremities on compression of her lower back.Her pain was severe and not responding to conservative therapy.She underwent mri of lumbar spine with mr cisternography.Opinion: findings consistent with large pseudomeningocele, which measures 12 cm x 0.5 cm in ap dimension x 9 cm in transverse dimension and extends from the level of the subcutaneous tissues into the epidural space and fills the spinal canal.There is a dural defect seen on the mr cisternogram sequence both anteriorly and posteriorly at the l4 level approximately.The anterior defect measures approximately 2 mm and the posterior defect measures 4 mm.The anterior fluid collection extends down to the level of the sacral canal and markedly displaces the cauda equina posteriorly.There is diffuse enhancement of the cauda equina consistent with arachnoiditis or arachnoid adhesions.There is also compression of the upper cauda equina and conus with posterior displacement of the conus identified.On (b)(6) 2011, (b)(6) 2012: patient presented for medication refill.Diagnoses: sacroiliitis; lumbago; sciatica; encounter for long term (current) use of other medications; postsurgical arthrodesis status; displacement of lumbar interbody intervertebral disc without myelopathy.On (b)(6) 2012: patient presented with pre operative diagnosis of pseudomeningocele with cerebrospinal fluid fistula and underwent expl oration of pseudomeningocele, reduction of pseudomeningocele, duraplasty with placement of a compartmental shunt as well as placement of a lumbar drain, 2 level laminectomy at 2 as well as 5 and removal of hardware.On (b)(6) 2014: patient presented with pre operative diagnosis of intrathecal cyst with severe thoracic spinal cord compression, tethered spinal cord and underwent laminectomy t6,t7 with intrathecal fenestration and then shunting of cyst.Indications: patient who has had previous lumbar spine surgeries (also has, interestingly, had an incidental finding of an aneurysm, which was clipped).Her lumbar spine had a significant problem, with probably a bmp-type of reaction which has likely led to this significant intracanal adhesion thickness unfortunately, the compression on the spinal cord has increased.On (b)(6) 2015: patient presented with pre operative diagnosis of spinal cord myelopathy with tethered spinal cord and underwent micro de-tethering of thoracic spinal cord with laminectomies, t2, t3, t4 as well as l2 and then primary dural repair and placement of lumbar drain.On (b)(6) 2015: patient underwent mri of thoracic spine without contrast due to inability to move right side and history of laminectomies.Impression: superior extension of thoracic laminectomies.The previously seen lobulated intrathecal collection appears improved although there may still be some residual subdural fluid at t4-t5 level where there is a slightly lobulated contour to the thoracic cord.There is less mass effect upon the chord.The extent of cord signal abnormality has increased along the lower thoracic cord and now extends to the t12 level, previously t11.This presumably reflects extension of cord edema.On (b)(6) 2015: patient underwent mri of thoracic spine with and without intravenous contrast for assessing change from previous imaging.Impression: extensive thoracic laminectomies are again noted from t2-l1.The previously noted surgical drain in the laminectomy bed fluid collection has been removed.Fluid is again noted throughout the laminectomy bed, with only minimal mass effect on the dorsal aspect of the upper thoracic thecal sac.Nonspecific enhancement is seen diffusely in the dorsal operative soft tissues around the laminectomy bed collection, with apparent contiguous thin enhancement in the lower thoracic epidural space.This is all probably postsurgical.Extensive thoracic spinal cord signal abnormality is again noted from t5 down to the conus medullaris, grossly unchanged.This may represent cord edema or myelomalacia or both.Small collections of possible residual loculated csf are visible in the upper thoracic spinal canal, with slight mass effect/indentation on the cord.Unchanged appearance of the broad t8-t9 disc protrusion, which contributes to central stenosis.On (b)(6) 2015: patient underwent ct of head due to weakness.Impression: unchanged postsurgical changes of prior left mca aneurysm clipping.Moderate to severe chronic small vessel ischemic changes which could obscure an area more recent ischemic injury.Senescent changes roughly commensurate patient age.Interval development of multiple air fluid levels at the paranasal sinuses, but without significant inflammatory mucosal thickening.No acute intracranial abnormality.The patient was presented for office visit for post op follow up.Assessments: (b)(6) post op de-tethering of spinal cord with t2, 3, 4, l2 laminectomies, repair of dura and placement of lumbar drain.Mri of thoracic spine showed abnormal cord signal increased along the lower thoracic cord and now extends to the t12 level.Also mild to moderate central canal stenosis at t8-9 from central disc protrusion.On (b)(6) 2015: patient was discharged with discharge diagnosis of tethered thoracic spinal cord with severe stenosis and myelopathy with paraplegia and hyperglycemia.On (b)(6) 2015: the patient presented with following complaints: t2-t1 lami with cord detether duraplasty resulting in pain gait disturbances decreased le function decreased i with adls dysphagia.
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Event Description
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It was reported that on: (b)(6) 2014: the patient was pre-operatively diagnosed with degenerative sacroiliitis and underwent the following procedure: minimally invasive left sacroiliac joint fusion.Intraoperative use of fluoroscopy.Intraoperative neurophysiological monitoring consisting of "ssep x4 and emg" bilateral lower extremity and anal sphincter.On (b)(6) 2014: the patient was pre-operatively diagnosed with thoracic stenosis with thoracic tethered cord and underwent the following procedures: laminectomy at t5 with redo opening of t6, t7 and t8.Laminectomies at t9, t10, t11, t12 and s1.Primary dural opening.Microsurgical release of tethers.Removal of previous shunt catheters.Primary closure with duraplasty.Indications for procedure: the patient had treatment using rhbmp-2, which may or may not have had anything to do with creating a significant inflammatory response.The patient had significant loculated collections of fluid throughout the thoracic spine, severe stenosis and myelopathy.
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Event Description
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It was reported that on: (b)(6) 2011: the patient underwent mri of the lumbar spine with mr cisternography with and without contrast.Findings: there is a large fluid collection in the subcutaneous tissues.This extends from the axial level of l1 down to s1 and extends into the epidural space.The fluid collection communicates with the epidural space dorsal to the thecal sac extending superior to the laminectomy site to the l3 level.There has been a laminectomy performed at l3-4, 4-5 and 5-1.There has also been prior surgery with placement of posterior rods and screws at l4-5 and 5-1.There has also been placement of an anterior fusion cage at the l3-4 level.There is fluid seen anterior and posterior to the thecal sac at the l3-4 and l4-5 levels and then there is fluid seen filling the canal at the l4-5 and 5-1 levels.The fluid collection at l4-5 and 5-1 is located anterior to the thecal sac and the fibers of the cauda equina are plastered around the posterolateral margin of the sac at the l4-5 and 5-1 levels.There is communication with the dorsal fluid collection and the fluid connection with the canal seen at the axial level of the superior endplate of l4 with pulsatility artifact seen at this level.This is seen best on axial cisternogram sequence slice 12.Then there is a communication with the anterior fluid collection just inferior to this approximately 3 mm with pulsatility artifact seen.The anterior fluid collection extends up to the l2 level.There is pulsatility within this fluid collection seen best on the stir sequence extending up to the l2 level.At the l3-4 level on the left side, the fluid does track to the left paravertebral margin.There has been a prior left foraminotomy at this level.There is no direct communication with the fluid on the left side of the spine at the l3-4 foramen and the canal on the fiesta or cisternogram sequence.There is deformity and compression of the upper fibers of the cauda equina with the anterior fluid collection at the l2 level and also the tip of the conus is posteriorly displaced.There is diffuse enhancement of the fibers the cauda equina.On (b)(6) 2012: the patient underwent mri lumbar spine due to back pain.Findings: there is posterior interbody fusion and wide laminectomies from l2-s1.There is posterolateral instrumental fixation from l3-s1.The interbody cage is uncovered by approximately 5 mm anteriorly at l4-s1.There is no hardware fracture.There are small lucencies surrounding the l4 pedicle screws suggestive of loosening.There is probable osseous fusion at l2-l4 and l5-s1 but not convincingly at l4-l5.There is an apparent at least partial linear fracture through the level l4-l5 level, which involve the disk space and bilateral pedicles.There is mild reverse s-shaped thoracolumbar scoliosis.There is chronic-appearing, 9 x 4.5 x 12.5 cm (transversexanteroposteriorxcraniocaudal) fluid collection centered w ithin the paraspinous muscles and extending from the l1-l2 level through the s1-s2 level.On (b)(6) 2012: the patient underwent mri of the lumbar spine with and without contrast.Findings: the hardware has been removed.A fluid collection is seen deep to the incision site extending from the l2 to the l5-s 1 level.The fluid is similar in signal intensity to cerebrospinal fluid on the t2 sequence; however, it demonstrates higher signal intensity than cerebrospinal fluid on the t1 images.The fluid tracks down to the left side of the thecal sac at the l3-4 level.There is no dural defect seen.There is enhancing tissue seen along the dorsal aspect of the thecal sac, and then there is nonenhancing material seen along the laminectomy site.This would be consistent with prior duraplasty.A shunt catheter has been placed in the thecal sac.This extends from the anterior fluid collection into the thecal sac.There is crowding of the fibers of the cauda equina from the conus inferiorly.Also the fibers of the cauda equina enhance and are thickened and clumped.There is also clumping of the nerve root fibers around the caudal aspect of the thecal sac and conus.On (b)(6) 2012: the patient underwent mri of the lumbar spine with and without contrast.Findings: the fluid collection within the laminectomy site is again identified extending from the l2 to the s1 level.This is isointense to csf.There is also connection of this fluid with fluid collection extending from the lateral margin of the thecal sac into the posterior left foramen at the l3-4 level.This is seen best on image 20.There is also deformity of the thecal sac.A fluid collection is seen anterior to the distal cord and conus tracking up into the inferior thoracic region.This then extends down to the level of the laminectomy site at l2 and l3.Then there is a shunt catheter seen between this fluid collection and the thecal sac.The fibers of the cauda equina are flat and thickened and deformed extending from l2 to the s1 level.There is then fluid also seen anterior to the thecal sac in the subdural space extending down to the sacral canal.The more posterior fluid collection measures 11 em in length by 7 em in transverse by 3.2 em in ap dimension.On (b)(6) 2014: the patient underwent thoracic spine mri without contrast and lumbar spine mri without contrast.Impressions: reaccumulation of lobulated and possible loculated csf intensity fluid which appears subdural in location along the mid thoracic spine from the t4-t5 level through the t7-t8 level.This causes new significant mass effect upon the mid thoracic cord.There is a new long segment cord signal abnormality from the t5 level through the t11 level.The superior to mid portion of this cord signal abnormality is central while the inferior portion appears to course along the dorsal columns.This likely represents edema although a presynrix is also possible.The ventral subdural csf collection along the thoracolumbar junction appears similar to the prior exam.The dorsal lateral fluid collection seen on (b)(6) 2014 has improved as seen on the prior exam of (b)(6) 2014.Similar appearance of the retained catheter along the lumbar canal.Stable large fluid collection along the lumbar laminectomy bed which may be postoperative collection or pseudomeningocale.The previously seen fluid collection along the lumbar laminectomy bed has significantly improved.On (b)(6) 2017: the patient was pre-operatively diagnosed with : failure to thrive as an adult.Unstageable sacrococcygeal pressure wound.Paraplegia, longstanding.Tissue necrosis is present in the wound( localized gangrene) and underwent the following procedures: local infiltration of 1% lidocaine with epinephrine for perioperative and post surgical pain control perfomed by the surgeon.Sharp excisional debridement of skin, soft tissue, muscle and bone, sacrococcygeal region for wound hygiene and potential for wound closure 12 x 6 cm.Tissue advancement 12 x 6 cm, sacrococcygeal region utilizing double opposing #1 nylon mattress sutures to distribute tension and allow for wound closure over the sacrococcygeal bone.Tissue eversion with complex closure 13 cm, sacrococcygeal region in a vertical fashion over 19 french round fluted drain for wound reconstruction, sacrococcygeal region ( 12 x 6 cm), length of wound closure 13 cm.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on (b)(6) 2011: the patient underwent mri of the lumbar spine with mr cisternography with and without contrast.Findings: there is a large fluid collection in the subcutaneous tissues.This extends from the axial level of l 1 down to s1 and extends into the epidural space.The fluid collection communicates with the epidural space dorsal to the thecal sac extending superior to the laminectomy site to the l3 level.There has been a laminectomy performed at l3-4, 4-5 and 5-1.There has also been prior surgery with placement of posterior rods and screws at l4-5 and 5-1.There has also been placement of an anterior fusion cage at the l3-4 level.There is fluid seen anterior and posterior to the thecal sac at the l3-4 and l4-5 levels and then there is fluid seen filling the canal at the l4-5 and 5-1 levels.The fluid collection at l4-5 and 5-1 is located anterior to the thecal sac and the fibers of the cauda equina are plastered around the posterolateral margin of the sac at the l4-5 and 5-1 levels.There is communication with the dorsal fluid collection and the fluid connection with the canal seen at the axial level of the superior endplate of l4 with pulsatility artifact seen at this level.This is seen best on axial cisternogram sequence slice 12.Then there is a communication with the anterior fluid collection just inferior to this approximately 3 mm with pulsatility artifact seen.The anterior fluid collection extends up to the l2 level.There is pulsatility within this fluid collection seen best on the stir sequence extending up to the l2 level.At the l3-4 level on the left side, the fluid does track to the left paravertebral margin.There has been a prior left foraminotomy at this level.There is no direct communication with the fluid on the left side of the spine at the l3-4 foramen and the canal on the fiesta or cisternogram sequence.There is deformity and compression of the upper fibers of the cauda equina with the anterior fluid collection at the l2 level and also the tip of the conus is posteriorly displaced.There is diffuse enhancement of the fibers the cauda equina.On (b)(6) 2012: the patient underwent mri lumbar spine due to back pain.Findings: there is posterior interbody fusion and wide laminectomies from l2-s1.There is posterolateral instrumental fixation from l3-s1.The interbody cage is uncovered by approximately 5 mm anteriorly at l4-s1.There is no hardware fracture.There are small lucencies surrounding the l4 pedicle screws suggestive of loosening.There is probable osseous fusion at l2-l4 and l5-s1 but not convincingly at l4-l5.There is an apparent at least partial linear fracture through the level l4-l5 level, which involve the disk space and bilateral pedicles.There is mild reverse s-shaped thoracolumbar scoliosis.There is chronic-appearing, 9 x 4.5 x 12.5 cm fluid collection centered within the paraspinous muscles and extending from the l1-l2 level through the s1-s2 level.On (b)(6) 2012: the patient underwent mri of the lumbar spine with and without contrast.Findings: the hardware has been removed.A fluid collection is seen deep to the incision site extending from the l2 to the l5-s 1 level.The fluid is similar in signal intensity to cerebrospinal fluid on the t2 sequence; however, it demonstrates higher signal intensity than cerebrospinal fluid on the t1 images.The fluid tracks down to the left side of the thecal sac at the l3-4 level.There is no dural defect seen.There is enhancing tissue seen along the dorsal aspect of the thecal sac, and then there is nonenhancing material seen along the laminectomy site.This would be consistent with prior duraplasty.A shunt catheter has been placed in the thecal sac.This extends from the anterior fluid collection into the thecal sac.There is crowding of the fibers of the cauda equina from the conus inferiorly.Also the fibers of the cauda equina enhance and are thickened and clumped.There is also clumping of the nerve root fibers around the caudal aspect of the thecal sac and conus.On (b)(6) 2012: the patient underwent mri of the lumbar spine with and without contrast.Findings: the fluid collection within the laminectomy site is again identified extending from the l2 to the s1 level.This is isointense to csf.There is also connection of this fluid with fluid collection extending from the lateral margin of the thecal sac into the posterior left foramen at the l3-4 level.This is seen best on image 20.There is also deformity of the thecal sac.A fluid collection is seen anterior to the distal cord and conus tracking up into the inferior thoracic region.This then extends down to the level of the laminectomy site at l2 and l3.Then there is a shunt catheter seen between this fluid collection and the thecal sac.The fibers of the cauda equina are flat and thickened and deformed extending from l2 to the s1 level.There is then fluid also seen anterior to the thecal sac in the subdural space extending down to the sacral canal.The more posterior fluid collection measures 11 em in length by 7 em in transverse by 3.2 em in ap dimension.On (b)(6) 2013: the patient underwent ct of the pelvis without intravenous contrast due to left hip pain, assess for sacroilitis and previous lower lumbar surgery.Impression: moderate degenerative osteoarthritis bilateral si joints.Postoperative changes lower lumbar spine.On (b)(6) 2013: the patient presented with thoracic pain.On (b)(6) 2014: the patient underwent mri thoracic spine.Impression: 1) unchanged appearance of the nonenhancing cyst within the ventral spinal canal from t2-t3 through visualized lumbar levels.Mass effect upon the spinal cord is unchanged as described.This likely represents an arachnoid cyst.2) small focus of central t2 hyperintensity within the spinal cord at t7 level.This could represent prominence of the central canal versus focal myelomalacia.3) degenerative changes as described, including a prominent at t8-9.These findings are similar to the prior exam.On (b)(6) 2014: the patient underwent mri of thoracic spine.Impression: 1) heterogenous nonenhancing material in the new laminectomy bed extending from t5-t6 through t7-t8 causes mild diffuse mass effect on the posterior aspect of the thecal sac, leading to effacement of the csf around the spinal cord in this region, without definite cord compression or edema.This laminectomy bed collection probably contains blood products, and there is suggestion of a surgical drain traversing the collection.2) the csf- intensity fluid collection previously notable in the ventral aspect of the upper thoracic canal has decreased in prominence, with less mass effect on the spinal cord.This presumably represents the results of interval surgery.No definite enhancing abnormality is seen.3) the t8-t9 disc protrusion or slightly superior extrusion seen on prior imaging is unchanged, again indention the ventral aspect of the cord without frank cord compression or edema.On 19 may 2014: the patient underwent dx thoracic spine 3 and spine 4 view exam.Impressions: 1) moderate degenerative change is noted of lower lumbar spine.2) postsurgical change is detected.No significant movement is suspected on the flexion or extension views.On (b)(6) 2014: the patient underwent dx procedure in or.The patient was diagnosed with degenerative sacroilitis and underwent following procedures: 1) minimally invasive left sacroiliac joint fusion.2) intraoperative use of fluoroscopy.3) intraoperative neurophysiological monitoring consisting of ssep* 4 and emg bilateral lower extremity and anal sphincter.On (b)(6) 2014: the patient underwent mri lumbar spine.Impressions: 1) lobular contour near the thoracolumbar junction.This part of collection has increased in size from the comparison mri performed (b)(6) 2013 with increased mass effect on and deformation of the concus medullaris.There is enhancement at the l2 level, suggesting scarring and/or adhesions.2) there is hazy enhancement extending throughout the lumbar canal in front of the l2-l5 laminectomy bed.Descending nerve roots in this region are abnormally clumped and abnormally spaced, again suggesting severe cannot be excluded by mri.Impressions: 1) since the postsurgical mri performed (b)(6) 2014 following mid thoracic laminectomies, there has been accumulation of csf intensity fluid around most of the thoracic spinal cord.This accumulation fluid causes mass effect upon and compression of the spinal cord, most notably between the levels of t5 and the conus, giving the cord, an indented and undulating contour.Fluid is primarily anterior in the mid thoracic region and posterior to the lower thoracic region.2) cord contour abnormality, compression and new t2 signal abnormality is noted between t5 and t7.This may represent myelomalacia given the apparent cord volume loss in the region, although a component od cord edema is not excluded.3) enhancing tissue in the t5-t8 laminectomy bed likely represents postoperative granulation tissue.This enhancing tissue extends ventrally into the epidural space, more on the right than the left, and the possibility of scarring and/or adhesions contributing to the areas of csf loculation is raised.On (b)(6) 2014: the patient underwent mri thoracic spine.Impressions: 1) laminectomies now evident at each level from t4-t5 down to at least t12-l1.Laminectomy bed fluid causes no mass effect on the thecal sac.Surrounding postoperative enhancement is noted in the dorsal soft tissues and also to a lesser degree circumferentially in the epidural space around the lower thoracic thecal sac.2) previously noted extensive and apparently loculated collections of csf surrounding and intermittently compressing the spinal cord are no longer seen.The spinal cord contour is much less undulating today, with no areas of frank compression.3) previously noted cord signal abnormality centered at the t6 level is again seen, and there is subtle additional signal noted in the lower half of the thoracic spinal cord today, likely related to prior compression.4) t8-t9 right paracentral protrusion noted previously is unchanged, without frank cord compression.On (b)(6) 2014: the patient underwent thoracic spine mri without contrast and lumbar spine mri without contrast.Impressions: 1) reaccumulation of lobulated and possible loculated csf intensity fluid which appears subdural in location along the mid thoracic spine from the t4-t5 level through the t7-t8 level.This causes new significant mass effect upon the mid thoracic cord.There is a new long segment cord signal abnormality from the t5 level through the t11 level.The superior to mid portion of this cord signal abnormality is central while the inferior portion appears to course along the dorsal columns.This likely represents edema although a presynrix is also possible.2) the ventral subdural csf collection along the thoracolumbar junction appears similar to the prior exam.The dorsal lateral fluid collection seen on (b)(6) 2014 has improved as seen on the prior exam of (b)(6) 2014.3) similar appearance of the retained catheter along the lumbar canal.4) stable large fluid collection along the lumbar laminectomy bed which may be postoperative collection or pseudomeningocele.5) the previously seen fluid collection along the lumbar laminectomy bed has significantly imp roved.On (b)(6) 2015: the patient was pre-operatively diagnosed with 1) spinal stenosis with t2-l1 laminectomy and revision on (b)(6).2) hypoperfusion with spinal cord involvement approximately at t5 level.3) neurogenic bowel secondary to myelomalacia.4) neurogenic bladder secondary to myelomalacia/spinal cord injury.5) deficits of activities of daily living secondary to above with now paraparesis.6) spasticity secondary to spinal cord involvement.Secondary diagnosis 1) depression 2) type 2 diabetes 3) hypertension 4) hyperlipidimia 5) polyneuropathy 6) history of pulmonary embolism back in 2012 7) spinal stenosis with 9 back surgeries in the past.8) skin integrity issues.9) neurogenic bladder as outlined above.10) urinary tract infection of e coli and klebsiella 12) right second toe nail onycholysis.On (b)(6) 2015: the patient underwent mri of the thoracic spine.Findings: there is no fracture or acute appearing osseous pathology.There is multilevel disc generation and endplate degenerative change, most pronounced at t9-t10.No acute changes detected in imaged lungs or ribs.On (b)(6) 2017: the patient was pre-operatively diagnosed with : 1) failure to thrive as an adult.2) unstageable sacrococcygeal pressure wound.3) paraplegia, longstanding.4) tissue necrosis is present in the wound( localized gangrene) and underwent the following procedures: 1.Local infiltration of 1% lidocaine with epinephrine for perioperative and post surgical pain control performed by the surgeon.2.Sharp excisional debridement of skin, soft tissue, muscle and bone, sacrococcygeal region for wound hygiene and potential for wound closure 12 x 6 cm.3.Tissue advancement 12 x 6 cm, sacrococcygeal region utilizing double opposing #1 nylon mattress sutures to distribute tension and allow for wound closure over the sacrococcygeal bone.4.Tissue eversion with complex closure 13 cm, sacrococcygeal region in a vertical fashion over 19 french round fluted drain for wound reconstruction, sacrococcygeal region ( 12 x 6 cm), length of wound closure 13 cm.
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