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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 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Anemia (1706); Conjunctivitis (1784); Cyst(s) (1800); Headache (1880); Hematoma (1884); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Tingling (2171); Cramp(s) (2193); Stenosis (2263); Pressure Sores (2326); Inadequate Pain Relief (2388); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Nerve Proximity Nos (Not Otherwise Specified) (2647); No Code Available (3191)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a transforaminal lumbar interbody and posterolateral spinal fusion from vertebrae l5 to s1 using rhbmp-2/acs.Reportedly, the patient experienced severe pain and symptoms and underwent two revision surgeries.The patient continued to experience low back pain and radiculopathy in her lower extremities.
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Manufacturer Narrative
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(b)(4).Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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Additional information: pt identifier, age/date of birth, weight, relevant tests/lab data, other relevant history, device manufacture date, evaluation codes.(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) 2006: patient underwent mri of lumbar spine.Sagittal views demonstrate relative maintenance of the lumbar lordosis with evidence of disc space collapse and retrolistheis at the l5-s1 level.The neuroforamen have modest compromise bilaterally.There is the beginnings of some modic changes.Axial view demonstrate central disc herniation at the l5-s1 level perhaps favoring the right side.All other levels appear relatively benign.Assessment: left leg sciatica pain ddd l5-s1.On (b)(6) 2007: patient presented for office visit with chief complaint of back and left leg pain.Patient describes her back pain as along the midline and lower lumbar spine radiating down to her tailbone.Patient also describes constant left leg pain involving the left buttock, posterior thigh, posterior calf and top the dorsum of her foot.Patient also has right buttock pain.Patient also underwent epidural injections which gave patient no relief.Review of symptoms is significant for headaches, blurred vision, loss of memory, joint pain and stiffness.On physical examination patient experienced facial twitching as well as speech stuttering through out examination.She ambulates with an antalgic gait to the left.She is tender is palpation through out the midline and lumbar spine.X-rays were performed and demonstrate disc collapse and retrolistheis at l5-s1 level.On (b)(6) 2007: patient underwent mri of lumbar spine without contrast due to low back pain.Impression: narrowing of the disc space of the l5-s1 level is associated with a slight right paracentral protrusion of the disc by 4 mm.This leads to mild spinal stenosis, mild bilateral l5 foraminal stenosis and mild stenosis of the lateral recesses of the s1 nerve roots, greater on right.A 16 x 9 mm perineural cyst occupies the left sacral canal at the s2 level.Patient had emg nerve conduction study performed of lower extremities.There is some slight increase in lumbar paraspinal insertional activity.Surgeon describes as a very weak support for the presence of non localized left lumbar motor radiculopathy.On (b)(6) 2007: patient presented for office visit.Patient complains of an unrelenting pain down the leg with motion.Assessment: disc space collapse, retrolistheis, ddd and herniation of l5-s1.Patient also underwent x-ray (pa and lateral views) study of chest.Impression: no active disease in the chest.On (b)(6) 2007: patient presented with chief complaint of back and left leg pain.Patient's review of systems revealed the following: headaches, blurred vision, loss of memory, joint pain and stiffness.Patient underwent x-ray examination, lateral flexion and extension views, which demonstrated disc space collapse and retrolistheis at the l5-s1 level.Patient's mri of (b)(6) 2006, was studied.Assessment: left leg sciatic pain, degenerative disc disease, l5-s1.On (b)(6) 2007: patient presented with preoperative diagnosis of degenerative disc disease with hypertension, radiculopathy and neural foraminal stenosis l5-s1 and underwent lumbar decompression with bilateral medial facetectomy and foraminotomies l5-s1.Posterior spinal fusion l5-s1.Placement of posterior instrumentation using rods and screws at l5-s1.Interbody fusion l5-s1.Placement of peek interbody cage 10 x 22 mm at l5-s1.Placement locally harvested morsellized autograft in the posterior gutters.Placement of rhbmp-2/acs collagen sponge combined with bone graft in the interbody space and posterior gutters.Per operative notes ".Through a transforaminal approach on the left a complete discectomy was performed and the endplates curetted to subcortical bleeding bone.A 10 x 22 mm peek interbody cage filled with rhbmp-2/acs collagen sponge and bone graft was then tapped into position." post-operative x-ray of lumbar spine was taken which demonstrate performance of laminectomy with placement of pedicular screws, short rods and disc space markers across the l5-s1 level.On (b)(6) 2007: patient presented with preoperative diagnosis of difficulty with drain removal and underwent open removal of lumbar drain with exploration of lumbar decompression at l5-s1.On (b)(6) 2007: patient presented for office visit.On (b)(6) 2007: patient who is seven weeks status post lumbar decompression and fusion of l5-s1 presented for office visit with chief complaint of pain along the tail bone.Patient underwent x-rays of lumbar spine which shows intact hardware and no evidence of fusion.Assessment: coccydynia.On (b)(6) 2007: patient presented for office visit.Patient is status post lumbar decompression and fusion of l5-s1.Patient continues to suffer from limiting coccydynia.Patient also reports a recent back spasm secondary to bending.On physical examination patient has spasms to the left paravertebral musculature of the lumbar spine.X-rays demonstrate the instrumentation to be in place and in appropriate alignment.On (b)(6) 2007: patient presented with preoperative diagnosis of coccydynia and underwent ganglion impar block under local anesthesia and there were no complications.Patient describes the pain as a burning sensation over the coccyx with tenderness.Review of systems is remarkable for headache, blurred vision, loss of memory, joint pain and stiffness.Assessment: elements of coccydynia.On (b)(6) 2007: patient underwent mri of sacrum and coccyx due to pain with sitting.Impression: status post l5-s1 posterior fusion with intrapedicular screw placement.L5-s1 degenerative disc disease with interbody fusion with modic type 1 marrow changes.Marrow signal abnormalities within the sacrum and coccyx consistent with focal area's of yellow marrow deposition, an anatomic variant of normal.No mr finding of insufficiency fracture, neoplastic infiltration or inflammatory disease.On (b)(6) 2007: patient presented for office visit with chief complaint of tailbone pain.Patient reported exacerbation of pain initially which prompted an mri which was performed on (b)(6).There are areas of focal yellow marrow at this position.An arachnoids cyst is noted at s2.On questioning patient stated that while it was numb she felt good which may confirm the diagnosis of coccydynia.On (b)(6) 2007: patient presented for office visit.Patient has failed to note any improvement in her pain and is unable to sit secondary to pain.Her leg pain has improved.X-rays demonstrate instrumentation to be in place.Evidence of interbody fusion.The coccyx is clearly absent from these views.Patient underwent mri of sacrum due to pain.Impression: intact osseous structures and marrow signal inflammatory soft tissue abnormality at the level of the inferior aspect of the coccyx.On (b)(6) 2008: patient presented with severe pain in coccygeal area.Patient is unable to sit or lay supine secondary to pain.On physical examination patient is exquisitely tender with palpation over the sacral region.Patient's mri dated (b)(6) 2007 shows evidence of fluid collection in and about the site of the coccygectomy.Assessment: chronic coccydynia despite coccygectomy.On (b)(6) 2008: patient presented for office visits.Patient still reports pain in coccyx.Patient also complains of right sided foot pain on the 4th and 5th metatarsal after a fall.Upon physical examination of her right foot she does have echomosis over the right 4th and 5th metatarsal.Patient is tender to palpation over this area.Ap and lateral oblique views of right foot shows no obvious fracture or dislocation.Ap and lateral views of lumbar spine shows evidence of fusion both in posterolateral gutters as well as interbody space.On (b)(6) 2010: patient presented for office visit.Patient reports severe left leg symptoms involving the lumbar spine, left buttock, posterior thigh and extending below the knee into the foot.On physical examination patient has tension signs with straight leg raising ion the left.Assessment: left sciatica.Patient underwent ct of lumbar spine without contrast due to numbness and tingling in left leg.Impression: moderate to moderately severe facet osteoarthropathy at l4-l5 with a mild diffuse posterior and leftward eccentric disc bulge.On (b)(6) 2011: patient presented with preoperative diagnosis of painful hardware, lumbar spine, l5-s1.Patient underwent removal of hardware of the lumbar spine l5-s1.Exploration of fusion mass, l5-s1.Lateral mass fusion, l5-s1.Per op-notes, "once we identified the hardware, retractors were placed to help with exposure.At which point with the help of equipment, we removed the caps as well as the rods bilaterally and then we removed the screws with a screw driver旅 identified fusion mass along the transverse processes extending onto the sacrum.At this point we removed some of the fusion mass in order to get the rod out.The equipment that was removed was from lumbar pedicle system." on (b)(6) 2012: patient underwent mri of pelvis with and without contrast, due to low back pain, sacral pain, and rule out fracture.Comparison study of mri (dated (b)(6) 2012) was also done.Impression: no occult fracture identified.Linear abnormal signal within the left gluteus maximus muscle at the sacral origin adjacent to the left s3 nerve root, which likely represents a focal area myonecrosis related to prior radiofrequency ablation.On (b)(6) 2013: patient underwent ct of lumbar spine w/o contrast.Impression: there is evidence of lower lumbar laminectomy with "ghost holes" at l5 following prior removal of pedicle screws.There is also evidence of lower lumbar posterior bony fusion.There is no evidence, however, of malalignment of the sagittal reformatted images.There is mild dextroscoliosis at the l4 level on the coronal reformatted images.Three (3) metallic screws across the left si joint related to recent fusion surgery.There is no ct evidence to suggest complications related to the metallic hardware.There is no evidence of fracture, osteomyelitis, or definite focal bony abnormality.On (b)(6) 2013: patient underwent x-ray study, 3 views, of the right sacroiliac joint.Conclusion: metallic fusion of the right si joint.On (b)(6) 2013: patient underwent bone scan, single area, due to back pain post her right si joint surgery ((b)(6) 2013) and left si joint surgery ((b)(6) 2012).Conclusion: there is increased tracer uptake across both si joints with more intense on the right is a site of more recent surgery.The increased uptake is not unexpected in the light of recent surgeries.On (b)(6) 2013: patient presented with preoperative diagnosis of hnp/ddd and spondylosis (l4-5) and status post lumbar instrumented fusion and posterior lateral lumbar interbody fusion at l5-s1 and underwent a minimally invasive lumbar decompression instrumented fusion at l4-5 ,percutaneous pedicle screw instrumentation at l4-5 bilaterally, complete medial facetectomy, hemilaminotomy, neural foraminotomy, discectomy at left l4-5, take down of epidural scar and revision, neural foraminotomy at left l4-5 extending to l5-s1,transforaminal lateral inter-body fusion at left l4-5 with peek inter-body cage, synthetic bone graft and neural monitoring.The spine wave sniper pedicle screw system and the stack inter-body cages were used.Per operative notes: small incisions were created over the l4-5 level which were carried down through the skin and then percutaneous pedicle screws were placed at l4 and l5 bilaterally.Epidural scar was removed from the previous surgery and it was freed with no further impingement down to the foramen.With the disk space exposed, a discectomy performed at that level down to bleeding endplates with the disk space prepared, the cage was impacted into place and expanded and some synthetic bone graft substitute was prepared on the back table and injected into the area of disk space.Intra-operative radiographs during spinal fusion at l4-l5 did not reveal any obvious hardware complication.On (b)(6) 2013: patient underwent mri of lumbar spine, with and without contrast, due to back pain.Impression: new l4 and l5 bilateral pedicle screws and stabilizing rods.Disc spacers at l4-l5 and l5-s1 levels.The central spinal canal and neural foramina are normal at all the lumbar levels.Left side perineural enhancement at l4-l5 as noted above.Finding may be secondary to presence of scar tissue.No arachnoiditis.On (b)(6) 2015: patient presented with preoperative diagnosis of multiple large intrasacral meningeal cysts within the sacrospinal canal causing sacral nerve root compression and sacral radiculopathy,l3-4 spondylolisthesis and stenosis and underwent following procedures: wrapping of large left and right s2,s3 and right s4 nerve root meningeal cyst/tarlov cyst causing sacral nerve root compression.Sacral lamina reconstruction with resorbable plating.Left lateral exposure l3-4 diskectomy, placement of peek spacer with dbm, interbody fusion, left l3-4 lateral plating, posterior l3-4 laminectomies, foraminotomies and medial facetectomies.Intraoperative electrophysiologic monitoring and intraoperative microscope and fluoroscopy is used.
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Event Description
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It was reported that on : (b)(6) 2007: patient presented for office visit.Assessment: status post lumbar decompression and fusion of l5-s1.On (b)(6) 2009: patient presented with pain in head left temple.Patient underwent mri of brain.Impression: mild cortical atrophy.On (b)(6) 2009: patient presented with chronic headache status post head injury(2001) (b)(6) 2009: patient presented for office visit with severe left side back pain and occipital neuralgia.Reason for visit: headache, s/p closed head in jury.Diagnosis: cervical region syndrome , cervicalgia.Patient underwent left occipital nerve stimulator trial.On (b)(6) 2010: patient presented for office visit.Patient reports severe left leg symptoms involving the lumbar spine, left buttock, posterior thigh and extending below the knee into the foot.On physical examination patient has tension signs with straight leg raising ion the left.Assessment: left sciatica.Patient underwent ct of lumbar spine without contrast due to numbness and tingling in left leg.Impression: moderate to moderately severe facet osteoarthropathy at l4-l5 with a mild diffuse posterior and leftward eccentric disc bulge.X-rays demonstrate hardware to be in place at l5-s1 level with solid fusion.Assessment: left sciatica.On (b)(6) 2011: patient presented with pain in right hip.Problem was worsening (b)(6) 2011: patient presented for office visit with right wrist pain.Assessment: right ulnar positivity.X-ray showed approximately 1mm to 2mm of ulnar positivity.On (b)(6) 2013: patient presented with chief complaint of lumbar nerve root; other mononeuritis of lower limb, low back pain.Assessment: lumbago; lumbosacral root lesions, not elsewhere classified; postlaminectomy syndrome, lumbar region; other mononeuritis of lower limb.On (b)(6) 2013: patient presented with complaint of tailbone pain.Assessment: other mononeuritis of lower limb.On (b)(6) 2013: patient presented with chief complaint of lumbar nerve root.Assessment: lumbosacral root lesions, not elsewhere classified.On (b)(6) 2013: patient presented with chief complaint of lumbar nerve root, low back pain.Assessment: lumbago; lumbosacral root lesions, not elsewhere classified.On (b)(6) 2013: patient presented with ¿left lbp¿ with leg pain.Assessment: lumbosacral root lesions, not elsewhere classified.On (b)(6) 2013: patient presented for a follow up visit with complaint of chronic back pain and severe pain in tail bone.Assessment: p ostlaminectomy syndrome, lumbar region.On (b)(6) 2014: patient underwent x-ray of lumbar spine.06 nov 2014: patient presented with complaint of low back pain, treatment of bilateral hip and thigh pain.Assessment: piriformis sy ndrome; sacroiliac dysfunction; failed back surgical syndrome.On (b)(6) 2014: patient presented with complaint of low back pain, treatment of bilateral hip and thigh pain.Assessment: piriformis sy ndrome; sacroiliac dysfunction; failed back surgical syndrome.Patient also underwent emg <(>&<)> ncv test due to complaint of lbp, left hip and leg pain, numbness and tingling.Impression: unremarkable study.On (b)(6) 2014: patient underwent lumbar myelogram and ct of lumbar spine.On (b)(6) 2015: patient presented for office visit and reported sacral pain worsened by sitting, radiating into left buttock, posterolateral thigh, posterior calf and into the bottom and lateral aspect of foot.On (b)(6) 2015: patient presented for office visit (b)(6) 2015: patient presented for office visit for pre-operative evaluation.On (b)(6) 2015: patient presented for office visit for alleged lumbar radiculopathy and anemia.On (b)(6) 2015: the patient presented with worsening lower back pain just above the area of her prior fusion radiating into the anterior thighs, particularly on left.On (b)(6) 2015: patient presented reporting double vision and mild headache.On (b)(6) 2015: on a telephonic conversation, patient stated that there was an increasing pain to bilateral legs.On (b)(6) 2015: the patient underwent x-ray of lumbosacral spine two views due to mononeuritis ¿nos¿, lumbosacral neuritis and surgery follow up.Impression: there has been interval surgery fusing l3 and l4.On (b)(6) 2015: the patient underwent mri of sacrum with and without contrast due to disorder of sacrum and lumbosacral neuritis.Impression: postsurgical changes of the lumbosacral spine including laminectomies at s1 and s2 with posterior mesh at the s2 level.There is prominent heterogeneous enhancing material in the epidural soft tissues at s1 end s2 likely reflecting scar tissue.This tissue surrounds the descending and exiting nerve roots at these levels.There are a few additional tiny cystic structures, no more than 4mm, within this tissue at the 52 level which may be post surgical or represent small peri-neural cysts.Partially imaged nonspecific at least 2 x 1.9 cm fluid collection within the subcutaneous fat of the left gluteal region.
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Event Description
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It was reported that on: (b)(6) 2011: the patient presented for follow up on hip pain, neck pain.On (b)(6) 2012: patient underwent mri left foot without and with contrast enhancement.Impression: unremarkable mri of left foot except for mild degenerative changes in first metatarsal phalangeal joint.On (b)(6) 2013: patient presented for office visit with axial back pain and right lower limb pain.Diagnosis: coccyx disorder.Impression: chronic low back pain, coccyx pain with radicular right lateral thigh and left foot pain.On (b)(6) 2013: patient presented for office visit for epidural steroid injection.Patient presented with following pre-op diagnosis: coccyx disorder.Patient underwent the following procedure: caudal with ganglion impar injection.On (b)(6) 2013: patient presented for follow up.On (b)(6) 2013: patient presented for orthopedic evaluation for low back pain.Patient underwent x-ray ap and lateral of lumbar spine.No acute findings.No fracture.Significant disc degeneration.Spurring about foramen at l5-s1.Diagnosis: degenerative disc disease.Low back pain.Lumbar radiculitis.Patient underwent ct lumbar spine.Impression: l3-4 degenerative retrolisthesis with mild spinal canal stenosis, mild to moderate bilateral foraminal stenosis.L4-5 level posterior instrumentation fusion, discectomy and interbody fusion device as well as posterior decompression without spinal canal or foraminal stenosis.No evidence of bony fusion.L5-s1 level evidence of solid bony fusion and posterior decompression as well as removed s1 pedicle screws without spinal canal or foraminal stenosis.Bilateral pelvic screws.On (b)(6) 2013: patient underwent x-ray of lumbar spine.Patient presented with chief complaint of low back pain and leg pain.Impression x-ray: solid fusion.Instrumented fusion interbody at l4-5 and l5-s1.Patient also underwent ct scan of lumbar spine.Impression: instrumented fusion, interbody and posterolateral at l4-5 and l5-s1.Wear at l3-4 disc space.No significant stenosis.Instrumentation is intact in lumbar spine.Diagnosis: low back pain.Lumbar disc disease.Failed back syndrome.Sciatica.On (b)(6) 2013: patient presented for office visit.Patient underwent the following procedure: trial spinal cord stimulator.On (b)(6) 2013: patient presented with chief complaint of axial back pain and right lower limb pain.Diagnosis: degenerative disc, coccyx disorder, low back pain.Radiculitis thoracic.Patient underwent thoracic spine x-rays.Impression: leads were identified in dorsal epidural space without evidence of migration.On (b)(6) 2013: patient presented for office visit with chief complaint of low back pain.On (b)(6) 2013: patient presented for office visit.Diagnosis: radiculitis thoracic, postlaminectomy syndrome lumbar region, spinal stenosis lumbar region.Patient underwent the following procedure: permanent spinal cord stimulator lumbar spine.
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Event Description
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It was reported that on (b)(6) 2015, the patient underwent x-ray of spine due to spinal cord stem removal.Impression: no spinal cord stimulator identified.
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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) 2011: patient presented for evaluation in neurosurgery clinic for consultation regarding having medical device(neurostimulator ) removed.Patient was implanted with neuro-stimulator for control of her chronic pain (in a left occipital nerve distribution) in (b)(6) 2009.Patient also has pain in the left temporal area and also in the left lateral occipital area.Patient reports she also has some problems with stimulator being present and causing soreness along the entire device from the lead wire down to ipg.The soreness causes her to have limited range of motion of her neck.On (b)(6) 2011, she decided to turn off the device.From that date until three days ago, she continued to have residual adequate pain control.However approximately 3 days ago patient started to have return of her baseline pain.Review of system revealed joint and muscle pain.Imaging studies of her skull, cervical spine and chest was performed to determine the type of stimulator.It does appear to be a paddle lead in the left occipital region.This was then connected via an extending wire to a pulse generator that is placed in the left anterior chest wall.There is no evidence of any obvious abnormalities with the device itself on the x-rays.On (b)(6) 2011: patient presented for follow up visit for allergic conjunctivitis, brain injury, hot flashes.Ros: patient notes leg cr amps.Assessment: history of traumatic brain injury.Other chronic allergic conjunctivitis.Contact dermatitis and other eczema due to other specified agents.Sleep related leg cramps.On (b)(6) 2011: patient presented for preoperative visit for removal of a nonfunctional neurostimulator.On physical examination patient has slightly decreased extension.On (b)(6) 2011: patient has onset of worsening headaches and photophobia.Patient presented with re-evaluation for worsening headaches.Patient has neurostimulator removed in (b)(6).Patient has dark streak under right thumb nail.Assessment: headache, unspecified disease of nail, neoplasm of certain behavior of skin.On (b)(6) 2011: patient underwent removal of neurostimulator.On (b)(6) 2011: the patient was pre-operatively diagnosed with occipital pain and underwent removal of occipital nerve stimulator and generator.On (b)(6) 2011: patient presented for office visit with chief complaint of what sound to be more trochanteric bursitis.Patient walks with antalgic gait.Patient in the lateral recumbent position with her right hip pointing up she has exquisite tenderness to palpation over top of right greater troch.X-rays (ap pelvis) shows previous posterior fusion l4-5 along with some hypo-opaque increased uptake on the right hip with no evidence of bad arthritis.Impression: right greater trochanteric bursitis.On (b)(6) 2011: patient underwent mri of lumbar spine with and without contrast due to coccygeal pain and hip pain right greater than left.Patient is status post nephrectomy.Impression: mild lumbar spondylosis.No frank herniations are appreciated.Post surgical changes are noted distally.On (b)(6) 2011: patient presented for office visit regarding low back.Patient has tenderness to palpation on the right greater troch area.On standing, patient has tenderness across her low back.Mri of lumbar spine shows hardware at l5-s1 but no evidence of transitional changes above the fusion mass.There does not appear to be any evidence of any disc herniation at l2-3 and l3-4 or any other issues on her lumbar spine.Impression: continued right hip pain and anterior thigh pain.Right greater trochanteric bursitis with it band tendinitis not improving after conservative care.On (b)(6) 2011: patient presented for follow up visit for her lumbar spine.Impression: status post lumbar decompression and fusion l5-s1 with painful hardware.On (b)(6) 2012: the patient underwent mri of lumbar spine with and without contrast due to left gluteal pain.Impression: l5-s1 intervertebral fusion with posterior decompression with removal of the pedicle screws.Central canal is decompressed at this level.There is some scar tissue surrounding the left s1 nerve root sleeve without frank nerve root compression.Edema in the soft tissues behind the sacrum extending from the surgical level, which may represent soft tissue strain.Minor degenerative changes in the upper lumbar spine without high grade central canal, lateral recess, neural foraminal stenosis.On (b)(6) 2012: the patient presented with chief complaint of sacrum pain.The patient underwent mri of pelvis with and without contrast due to left gluteal pain.Impression: post-operative changes of a l5-s1 interbody fusion with mild enhancement/scar tissue surrounding the s1 nerve roots, left greater than right.Mild abnormal signal within the right greater than left quadratus femoris muscle, which can be associated with clinical findings of ischiofemoral impingement.Right gluteal medius and minimum tendinopathy.On (b)(6) 2012: the patient underwent caudal approach epidural steroid injection of sacrum.On (b)(6) 2012: the patient underwent x-ray of sacrum and coccyx minimum 2 views due to midlin coccydynia.Impression: posterior lumbar decompression and interbody fusion at l5-s1.Mild degenerative changes in sacroiliac joints.02 apr 2012: the patient underwent ct guided l4-l5 and l5-s1 bilateral perifacetal steroid injection due to low back pain.On (b)(6) 2012: the patient underwent ct guided bilateral l5-s1 facet lateral medial branch blocks.On (b)(6) 2012: the patient underwent left sacro-iliac joint steroid injection due to low back pain.On (b)(6) 2012: the patient underwent x-ray of lumbar spine due to back pain and lumbar compression fracture.Impression: prior l5 posterior decompression and l5-s1 fusion with osseous fusion of the articular columns and disc without hardware complication identified.No fracture identified.Moderate degenerative disc changes at l3-l4 and l4-l5 with mild retrolisthesis of l4 on l5 which is not significantly changed from prior exam.Prior left nephrectomy surgical changes.On (b)(6) 2012: the patient underwent radiofrequency ablation of the lateral medical branches of left sacroiliac joint.On (b)(6) 2012: the patient presented for follow up on left sacroiliac joint.On (b)(6) 2012: the patient underwent ¿ps¿ ct injection spine facet lumbar sacral.On (b)(6) 2012: the patient also underwent mri of lumbar spine with and without contrast due to low back pain.Impression: no evidence of compression fracture.Post surgical changes from laminectomy with interbody fusion at l5-s1.Enhancing epidural scar within the lateral recess, right greater than left, at l5-s1 surrounding the traversing s1 nerve root.On (b)(6) 2012: the patient underwent lumbar discogram under fluoroscopic guidance.On (b)(6) 2012: the patient presented for follow up for chronic low back pain and bilateral hip pain.On (b)(6) 2012: the patient called office to request some sedative for sleep.On (b)(6) 2012: patient underwent provocative/neutralization testing, a titration of skin tests were done, nickel, aluminium and titanium were found to be positive by both local reaction(both immediate and delayed).On (b)(6) 2012: the patient underwent bone scan due to low back pain extending to both thighs.Impression: moderate to intense radiotracer uptake at the l4-l5 facets bilaterally compatible with active facet arthropathy.Postsurgical changes from laminectomy and instrumented fusion at l5-s1 status post posterior fusion hardware removal.The patient also underwent x-ray of lumbar spine 4 or more views due to lumbar stenosis.Impression: post surgical change at l5-s1 with unchanged alignment.On (b)(6) 2014: the patient presented with bilateral hip pain.On (b)(6) 2014: patient underwent x-ray of lumbar spine.Impression: no evidence of hardware complication/failure.Mild retrolisthesis of l3 on l4.The vertebral body heights are maintained.Ssc generator present in the left gluteal soft tissue with leads extending superiorly out of the plane of imaging.Surgical clips present in the left hemiabdomen.On (b)(6) 2014: patient underwent lumbar myelogram.Impression: successful lumbar myelogram under fluoroscopic guidance.Patient also underwent ct of lumbar spine post myelogram with contrast protocol.Impression: stable postoperative changes status post l4-5 fusion with posterior decompression, l5-s1 disc spaces and bilateral sacroiliac joint fusion.Moderate disc bulge at l3-4 with ligamentum flavum hypertrophy causing mild right and moderate left neuroforaminal narrowing.On (b)(6) 2015: the patient presented for removal of spinal cord stimulator.On (b)(6) 2015: the patient presented for completing ¿h<(>&<)>p¿.On (b)(6) 2015: the patient was pre-operatively diagnosed with failed back syndrome.Failed spinal cord stimulator and underwent the following procedure: removal of epidural spinal cord stimulator leads.Removal of left gluteal spinal cord stimulator generator.Continuous use of c-arm fluoroscopy for anatomical guidance and explanation confirmation.
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Event Description
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It was reported that on, (b)(6) 2012: patient presented to office for evaluation of her back.Physical examination: patient is apparently uncomfortable.She has exquisite tenderness to palpation over the area of left sacroiliac joint.Diagnostic test were reviewed and these demonstrate fusion at l5-s1 level without any evidence of other acute osseous abnormality.Assessment: left si joint dysfunction.On (b)(6) 2012: patient was diagnosed with left sacroiliac joint dysfunction and underwent minimally invasive left sacroiliac joint fus ion.Operative course: ".The back was then prepped and draped in the usual sterile fashion.Ap and lateral c-arm images were utilized to visualize the si joint on the left side.A small incision was created on the posterior buttock.The incision was carried down through skin and then blunt dissection was carried down to the gluteal fascia.A guidewire was placed in the usual globus fashion.The ap and lateral c-arm images verified good positioning.Reaming was performed over that guidewire, and some of the bone graft was placed within the screw.The screw was placed until it was secure.Then a guide was utilized to place screws number two and three in an identical fashion.Images demonstrated all hardware to be in excellent position in both the ap and lateral projections.The wound then copiously irrigated.The subcutaneous tissues closed using vicryl suture and the skin closed using monocryl suture.Sterile dressings were applied.Patient was transferred to recovery room instable condition." on (b)(6) 2012: patient was discharged.On (b)(6) 2012: patient presented for office approximately 2 weeks post left sacroiliac joint fusion.Patient recently noticed some pain down the left leg and has difficulty with sleeping on her left side at night.Physical examination: there is some ecchymosis in the area.There is exquisite tenderness to palpation over the area of the trochanteric bursa.X-rays of pelvis were obtained which demonstrate si joint screws in place on the left side in good position.No evidence of loosening or failure.Assessment: status post left si joint fusion, trochanteric bursitis, left hip.On (b)(6) 2013: patient presented for recheck of her neck.X-rays of sacrum and pelvis were obtained which demonstrate the hardware from the si joint fusion in good position.There does appear to be good consolidation in early fusion of si joint.Also there is tremendous bone growth and fusion at the l5-s1 level.Patient underwent ct of pelvis without contrast due to pain.Impression: there is evidence of prior lower lumbar laminectomy with "ghost holes" at l5 following prior removal of pedicle screws.There is also evidence of lower lumbar posterior bony fusion and there is disc prosthesis at the l5/s1 level.There is no evidence, however, of mal alignment at these levels.There is evidence of insertion of metallic screws related to current su joint fusion.There is no evidence to suggest complication related to the metallic screws.There is no evidence of fracture, osteomyelitis, or definite focal bony abnormality.On (b)(6) 2013: patient returns to office for recheck of her back and legs after her ct scan but also complaints of right side si joint pain.The low back shows minimal tenderness to palpation at the left si joint.There is exquisite tenderness with palpation on the right side.Assessment: right si joint dysfunction.Persistent lower extremity pain, questionable etiology.Patient presented for office visit with complains of right wrist pain.Which reportedly aggravated with using crutches after her si joint fusion.There is some tenderness with palpation at the area of the druj.X-rays of right wrist were obtained in office which demonstrate an ulnar positive variant.There also appears to be a cystic formation in the lunate consistent with an ulnar abutment syndrome.Assessment: ulnar abutment syndrome, right wrist (b)(6) 2013: patient was diagnosed with right si joint dysfunction and underwent right si joint fusion.Instrumentation : globus si lock, si joint fusion screws.On (b)(6) 2013: patient presented for office visit approximately 2 weeks status post right si joint fusion.Diagnostic tests: x-rays of the pelvis obtained in the office today demonstrate hardware in place bilaterally at the si joints.There is excellent position of the hardware and good stabilization of the joints.A ct myelogram performed at holy spirit a few weeks ago also demonstrates fusion at the l5-s1 level, some stenosis at the l4-l5 level, but no specific nerve root cut-out.Assessment: status post right si joint fusion.Persistent lower extremity symptoms, questionable etiology.Patient presented with chief complaint of right wrist pain.Diagnostic tests: x-rays reveal +3 ulnar variance with mild degenerative changes in the druj.She has a large cyst on the ulnar border of the lunate.Assessment: right wrist ulnar impaction.On (b)(6) 2013: patient presented for office visit status post bilateral si joint fusions.The left side does have some tenderness at one specific spot more superiorly along the area of the si joint.Diagnostic tests: x-rays of the pelvis were obtained in the office today.Those studies demonstrate hardware in place for the bilateral si joints.There is no evidence of hardware loosening.There does appear to be nice compression across the si joints and early fusion there.Assessment: status post bilateral si joint fusion.Patient underwent mri of right wrist due to chronic wrist pain ulnar side.Impression: partial tear of the triangular fibrocartilage particularly on the radial side.Findings highly suggestive of ulnolunate abutment syndrome.Torn lunotriquetral ligament.On (b)(6) 2013: patient presented with complaint of tailbone pain.Assessment: other mononeuritis of lower limb.Patient underwent radiofrequency lesioning of peripheral nerve site: left nerve,s4.On (b)(6) 2013: patient presented with bilateral sacral disorder.Patient demonstrates limited bilateral lower extremity rom/mobility/flexibility status post si fusion bilateral sides.On (b)(6) 2013: patient was diagnosed with right wrist ulnar impaction and underwent right wrist arthroscopy with debridement, ulnar shortening osteotomy.Intraoperative fluoroscopy was also used.On (b)(6) 2013: patient presented for office visit.Patient states that now she has a sore spot in her back that radiates down into her lower extremity.She states that when she flexes and extends she feels a popping-type sensation in her low back.The pain and the area of her sensation is not in the si area.It is a little bit more proximal.Physical examination :there is some tenderness to palpation of the low lumbar paraspinal area.Diagnostic tests: x-rays of the low lumbar spine and pelvis obtained in the office today.Those studies demonstrate the previous hardware from the si joint fusions in good position.There is no evidence of loosening or hardware failure there.It also demonstrates her previous lumbar fusion at l5-s1.It appears that there is excellent consolidation of the bone graft and fusion bilaterally, and there is an interbody cage in place that also appears to be well healed and consolidated.Assessment: low back pain with radiating lower extremity pain.Previous bilateral si joint fusions.Previous lumbar fusion l5-s1.On (b)(6) 2013: patient presented with chief complaint of lumbar nerve root.Assessment: lumbosacral root lesions, not elsewhere classified.Patient has low back pain with radiation to anterior and posterior thigh which is worse with sitting.His lumbar spine ct shoes nothing to account for this new pain.On physical examination patient is tender left of midline around l4.Patient underwent lumbar transforaminal esi.Patient presented for recheck after right forearm/wrist surgery.On (b)(6) 2013: patient underwent diagnostic test of right wrist which show bony architecture is intact without evidence of fracture or dislocation.No significant soft tissue abnormality is seen.She is approximately 3-4 ulnar variance.The plate is in good position as is the ulna.On (b)(6) 2013:patient underwent lumbar transforaminal esi.On (b)(6) 2013: patient underwent mri sacrum routine without contrast.Impression: postsurgical changes of prior metallic bilateral sacroiliac joint fusion surgeries.Patient underwent mri of spine lumbar with and without contrast.Impression: postsurgical changes compatible with l5-s1 decompressive laminectomy and intervertebral fusion.Mild multilevel degenerative changes, most prominently involving the l4-5 with moderate to severe left neuroforaminal stenosis at this level.On (b)(6) 2013: patient presented for office visit.On physical examination, there is little bit of tenderness on the left side.A positive straight-leg raise test on that left side.Diagnostic tests: an mri of the lumbar spine obtained on (b)(6) 2013 was available for review.Those studies demonstrate a previous lumbar instrumentation at the l5-s1 level that appears to be well fused with good canal patency.At the l4-l5 level there is facet degeneration along with a disc herniation at the l4-l5 level on the left side.This causes fairly significant foraminal and lateral recess stenosis.Assessment: degenerative disc disease, l4-l5, mild to moderate at l3-l4.Status post previous lumbar decompression and instrumentation at l5-s1.Status post bilateral si joint fusion.On (b)(6) 2013: patient was discharged.On (b)(6) 2013: patient presented for second postoperative visit right ulnar shortening and two weeks post operative minimally invasive lumbar fusion.Patient still has some persistent pain in the wrist.Diagnostic testing: two view wrist x-rays show the bony architecture is intact without evidence of fracture or dislocation.No significant soft tissue abnormality is seen.The hardware is in good position and the osteotomy appears to be healing.X-rays of the lumbar evidence of spine were obtained.Those studies demonstrate hardware in place.There is no screw loosening or failure.Cages in place in the interspaces.Assessment: 6 weeks after right ulnar shortening.Two weeks status post minimally invasive lumbar instrumented fusion.On (b)(6) 2013: patient presented for office visit.Examination of the back shows some tenderness to palpation of the lumbar area and in the area of the si joints, but is seems to be fairly superficial.Diagnostic tests: two-view x-rays of lumbosacral spine were obtained in the office today.Those studies demonstrate hardware from the si joint fusion surgeries.The si joints do appear to consolidating nicely and fusing.The hardware at l4-5 is in good position with some healing there, excellent restoration of the height.The l5-s1 fusion is nicely healed.Diagnosis: status post lumbar instrumented fusion l4-5.Status post bilateral si joint fusions.On (b)(6) 2013: patient presented with chief complaint of right little finger numbness and tingling 13 weeks after right ulnar shortening.Tinel's sign at the cubital tunnel and flexion test are positive.Assessment: probable right cubital tunnel syndrome, painful deep hardware.On (b)(6) 2013: patient underwent ap lateral and two oblique images of right wrist.These are inconclusive regarding healing of osteotomy.There does not appear to be any loose hardware.Patient underwent ct of right forearm.There is a volar plate and screws fixating an osteotomy site at the distal diaphyseal third of the ulna.The osteotomy line is clearly visible.There is no malalignment.There is a small amount of callus formation about the tip o f the middle screw fixating the plate.No discontinuity of the plate is identified.No soft tissue abnormality is noted such as a collection.On (b)(6) 2013: patient presented for follow up visit.Physical exam: there is tenderness about the incision on the ulnar border of the wrist.Diagnostic testing: ap, lateral, and oblique images repeated today do reveal the osteotomy is healed.Assessment: painful hardware left ulnar shortening (b)(6) 2013: patient presented for office visit.Diagnostic tests: x-rays of the lumbar spine were obtained in the office today.Those studies demonstrate hardware in place in the lumbar spine.There is excellent consolidation of the bone graft.There is no evidence of hardware loosening or failure assessment: three months status post minimally invasive lumbar instrumented fusion.On (b)(6) 2013: patient was diagnosed with right wrist ulnar painful plate and underwent right wrist ulnar plate removal.On (b)(6) 2013: patient presented for office visit with recurrent tailbone pain.Assessment: persistent pain at left sacrum.Successful resolution of her lle radicular pain after last lumbar spine surgical procedure.Postlaminectomy syndrome, lumbar region.On (b)(6) 2013: patient presented for office visit post op right ulnar plate removal.Diagnostic testing: ap and lateral images of the forearm reveal a plate removed with a healed osteotomy.Assessment: plate removal right forearm.On (b)(6) 2013: patient underwent xr guided multiple peripheral nerve blocks.On (b)(6) 2013: patient presents for axial back pain and right lower limb pain.Ros: musculoskelatal: reports joint pain.Neuro: reports numbness.Significant tenderness over coccyx bone, lumbar paraspinals.Impression: patient with chronic low back, coccyx and radicular bilateral lower limb pain with parasthesias and numbness in all toes.No alleviation of symptoms with recent caudal epidural and ganglion impar block.Her symptoms consistent with coccydynia chronic radiculitis.On (b)(6) 2013: patient is unable to sit due to severe pain in her back.Patient has significant diminished lumbar flexibility with forward flexion.She has significant tenderness over the lumbar spine to palpation.Diagnosis: degenerative disc disease.Low back pain lumbar radiculitis.
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Event Description
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It was reported that on (b)(6) 2014: the patient presented with low back pain-lumbar area and hip pain; bilateral lower extremity numbness and difficulty in ambulation.(b)(6) 2014: the patient presented with back pain-lumbar area and gait problem.Findings: the patient is status post posterior fusion at l4-l5 with interbody spacers at l4-l5 and l5-s1.2 cannulated screws traverse the right s1 joint and 3 cannulated screws traverse the left s1 joint.No evidence of hardware complication/failure.Mild retrolisthesis of l3 on l4.The vertebral body heights are maintained.Scs generator present in the left gluteasoft tissue with leads extending superiorly out of the plane of imaging.Surgical clips present in the left hemiabdomen.(b)(6) 2014: findings from patients spine imaging studies are as indicated: standing films show hardware at l4-5 and bilateral s1 screws (3 on left, 2 on right).There is retrolisthesis of l3-4 and l4-5.Ct imaging from (b)(6) 2014 shows stable interbody fusion at l5-s1 with evidence of lucency surrounding l4-5 interbody graft.(b)(6) 2014: patient was ordered to undergo ir lumbar myelogram, ct cervical spine post myelogram with contrast protocol and ct lumbar spine post myelogram with contrast protocol due to diagnosis of s/p lumbar fusion and lumbar stenosis.(b)(6) 2014: patient was ordered to undergo x-ray lumbar myelogram due to diagnosis of s/p lumbar fusion and lumbar stenosis.(b)(6) 2014: findings: patient is status post l5 posterior decompression with bilateral l4-5 pedicle screws and fixation rods.No evidence of hardware failure or loosening.There is a disc spacer at l4-5.No osseous fusion is seen at l4-5 disc space.There is some osseous bridging at the l5-s1 disc space.Patient is also status post bilateral sacroiliac joint fusion.Hardware appears intact without evidence of loosening.There is minimal retrolisthesis at l3-4, unchanged from prior exam.Vertebral body heights are preserved.Mild degenerative change including schmorl's nodes are seen at t12-l1 and the superior endplate of l2.Old screw tracts are seen at s1 bilaterally.Perivertebral soft tissues and visualized surrounding organs and viscera.No fractures, dislocations, or epidural hematoma." t1 2 -l 1 = there is no evidence of spinal stenosis, disc bulge or neural foraminal narrowing.No facet degenerative disease." l1-l2 = there is no evidence of spinal stenosis, disc bulge or neural foraminal narrowing.No facet degenerative disease." l2-l3 = small disc bulge causing minimal impression on the ventral thecal sac.There is no evidence of spinal stenosis or neural foramina narrowing.No facet degenerative disease." l3-l4 = moderate disc bulge with impression on the ventral thecal sac with associated ligamentum flavum hypertrophy causing mild right and moderate left neural foraminal narrowing.There is no evidence of spinal stenosis." l4-l5 = there is no evidence of spinal stenosis, disc bulge or neural foraminal narrowing." l5-s1 = there is no evidence of spinal stenosis, disc bulge or neural foraminal narrowing.Marked facet degenerative disease.(b)(6) 2014: patient was informed via phone that the myelo/ct scan does not show any surgical lesions.No loose screws.Just some mild arthritis above the prior fusion.Pain management is her best option, not more surgery.".
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