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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 7510200 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Pulmonary Embolism (1498); Anemia (1706); Chest Pain (1776); Cyst(s) (1800); Headache (1880); Hematoma (1884); Incontinence (1928); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Seroma (2069); Thrombosis (2100); Urinary Retention (2119); Vomiting (2144); Weakness (2145); Tingling (2171); Cramp(s) (2193); Stenosis (2263); Injury (2348); Depression (2361); Sore Throat (2396); Numbness (2415); Neck Stiffness (2434); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2008 the patient underwent a spinal fusion surgery on the lumbar region of her spine from l4-s1 using rhbmp-2/acs.The patient's post-op period was marked by severe pain and weakness in her legs.It was reported that the patient underwent a revision surgery on (b)(6) 2012 to decompress her l4-s1 nerve roots due to overgrown bone.It was reported that the bmp used leaked into her spinal canal causing significant root compression at the l4-l5 and l5-s1 levels.It was reported that the l5-s1 nerve root was completely encased in bone that grew into the nerve, causing discoloration and severe compression.It was reported that the patient continues to experience severe and unrelenting pain that radiates into her lower extremities.She suffers from numbness and burning down through her legs.Patient is unable to sit or stand for long periods.
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Manufacturer Narrative
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(b)(4).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.Products from multiple manufacturers were implanted 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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(b)(4).
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Event Description
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It was reported that on (b)(6) 2005 the patient underwent x-ray of lumbosacral spine.Impression: normal si-joints.Lumbosacral spine.Osteopenia.Moderate disk space narrowing l4-5.(b)(6) 2005 the patient presented with: 1.Left sacroiliac joint pain with lumbosacral spondylosis.2.Left trochanteric bursitis.The patient underwent: 1.Left sacroiliac joint injection.2.Left trochanteric bursa injection.3.Fluoroscopic guidance.4.Conscious sedation.No complications.The patient tolerated the procedure well and was sent to the recovery room in good condition.(b)(6) 2005 as per medical records, mri did not show a specific fluid collection or a specific area of bone abnormality sufficient to obtain an adequate biopsy.Ct showed no findings in the lumbar spine or sacrum to suggest osteomyelitis.(b)(6) 2005: the patient underwent ct scan of the lumbar spine.Impressions: no complication was reported.No ct findings in the lumbar spine or sacrum to suggest osteomyelitis.(b)(6) 2005 the patient underwent mri of lumbar spine.Impression: asymmetric enhancement in the posterior paravertebral muscles extending from l5 downwards, almost up to the coccyx.Abnormal signal in s1 and l5 spinous processes, concerning for osteomyelitis.No convincing evidence of discrete abscess formation.(b)(6) 2006: per billing record, the patient underwent x-rays of the chest and x-rays of the shoulder.(b)(6) 2008: per billing record, the patient underwent "pap" smear screening.(b)(6) 2008: per billing record, the patient underwent ultrasound of pelvis and transvaginal.(b)(6) 2008: per billing record, the patient underwent bilateral mammogram screening.(b)(6) 2008: per billing record, the patient underwent ultrasound of breast (unilateral and bilateral) and mammogram, right.(b)(6) 2008: per billing record, the patient underwent ct of head.(b)(6) 2009: per billing record, the patient underwent ct of abdomen and pelvis.(b)(6) 2009: per billing record, the patient underwent x-rays of the abdomen.(b)(6) 2009: per billing record, the patient underwent mammogram screening bilateral.(b)(6) 2010: per billing record, the patient underwent x-rays of the abdomen, ct of abdomen and ct of pelvis.(b)(6) 2010: per billing record, the patient underwent ct scan of the head.(b)(6) 2011: per billing record, the patient underwent ct scan of head.(b)(6) 2012: the patient presented with low back pain radiating down the right leg.Assessment: lumbar post-laminectomy syndrome; bilateral lumbar radiculopathy, right greater than left; lumbar somatic dysfunction; history of migraine headaches.(b)(6) 2012: the patient presented for an office visit with lumbar pain radiating to right leg, right foot and right buttocks.The quality of pain was described as achy, burning, cramping, deep, knife-like, sharp, shooting, stinging and tight.The pain was accompanied by spasms, stiffness and tingling.The symptoms worsened with bending, exercising, lifting, pushing, sitting and standing.(b)(6) 2012: the patient presented for an office visit with lumbar and left lower extremity pain radiating to left leg and left foot.The pain was described as burning, deep, numbing, shooting, stinging and tight.Pain was accompanied with numbness.(b)(6) 2013: the patient presented with lower right sided back pain.Assessment: thoracic/lumbosacral neuritis/radiculitis; postlaminectomy syndrome lumbar region.On (b)(6) 2013 the patient underwent x-ray of lumbosacral spine s/p fusion lumbar pain.(b)(6) 2013: the patient underwent ct lumbar spine and mri of lumbar spine.On (b)(6) 2013 the patient was diagnosed for total hip arthroplasty.The patient underwent x-ray of right hip and pelvis.(b)(6) 2014, the patient was presented for office visit with low back pain radiating down bilateral leg.Impressions: sacrolitis, th oracic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine, insomnia, questionable permanent nerve damage.(b)(6) 2014: per billing record, the patient underwent x-rays of the chest and ct scan of head.(b)(6) 2015: per billing record, the patient underwent x-rays of the chest.
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Event Description
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It was reported that on (b)(6) 2006 the patient presented for tsh (thyroid stim hormone) test.(b)(6) 2006 the patient was presented for office visit with pain in her back."the patient underwent u/s transvaginal non-ob and pelvic non -ob complete.".
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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) 2008 the patient underwent a spinal fusion surgery on the lumbar region of her spine from l4-s1 in which infuse was used.The patient's post-op period was marked by severe pain and weakness in her legs.It was reported that the patient underwent a revision surgery on (b)(6) 2012 to decompress her l4-s1 nerve roots due to overgrown bone.It was reported that the bmp used in her (b)(6) 2008 surgery had leaked into her spinal canal causing significant root compression at the l4-l5 and l5-s1 levels.It was reported that the l5-s1 nerve root was completely encased in bone that grew into the nerve, causing discoloration and severe compression.It was reported that the patient continues to experience severe and unrelenting pain that radiates into her lower extremities.She suffers from numbness and burning down through her legs.Patient is unable to sit or stand for long periods following her surgery with infuse.This prevents her from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she has otherwise suffered serious injuries.Notified date: (b)(6) 2015, updated date: (b)(6) 2015 implant date(s): (b)(6) 2008 patient demographics: (b)(6), race: white history/comorbidities: (pre-existing medical conditions, smoking status, prior surgeries): pseudoarthrosis of the lumbar spine and post-laminectomy syndrome, migraine headaches, patent foramen ovale without any history of tia or cva, , hypothyroidism, depression, uterus fibroids, migraines, atrial septal defect, kidney stone, pulmonary embolism, osteomyelitis allergies: compazine - anxiety, penicillin anaphylaxis/shock, reglan (metoclopramide hcl) social history: former smoker 0.25 packs/day for 10 years, no significant history of alcohol usage, no history of drug abuse surgeries: laparoscopic cholecystectomy, endocardiac echocardiogram for pfo analysis, posterior lumbar interbody fusion , hysterectomy, right hip tear repair, laminectomy and uterine embolization, bilateral decompressive lumbar discectomy, posterolateral fusion, osteophytectomy, foraminotomy family medical history: father:- scleroderma, coronary artery disease and heart failure, died of mi; sister:- diagnosed with breast cancer; brother:- lupus medications: methocarbamol (robaxin), diclofinac potassium (cataflam), oxycodone-acetaminophen (percocet), fluoxetine hci (prozac), trazodone (desyrel), levothyroxine sodium (tirosint), ondansetron (zofran), clonazepam (klonopin), eletriptan (relpax), topiramate (topamax), fentanyl (duragesic) transdermal patch 72 hr 25 mcg/hr, estradiol (vivelle), hydrocodone-acetaminophen (norco), ondansetron(zofran), lortab, epinephrine (easton), heparin, clindamycin (cleocin), gentamicin, hydromorphone (dilaudid), naloxone (narcan), diphenhydramine (benadryl), docusate (colace), senna (senokot), magnesium hydroxide, bisacodyl (dulcolax), dextrose, acetaminophen (tylenol), alum & mag hydroxide-simeth (mylanta, maalox), simethicone (mylicon), zolpidem (ambien), diazepam (valium), methylprednisolone sodium succinate (solu-medrol), menthol (nice), sodium chloride, oxycontin, theragran, amitriptyline, protonix, deseryl, tirosint it was reported that on (b)(6) 2008, the patient presented with the following pre-op diagnosis: bilateral disc herniation with discogenic back pain, l4-l5 and l5-s1.The patient underwent the following procedures: 1.Lumbar decompressive laminectomy, l4, l5, s1.2.Bilateral decompressive lumbar discectomy , bilateral l4-l5 and l5-s1.3.Posterior lumbar interbody fusion, l4-l5 and l5-s1.4.Posterolateral fusion, l4-s1 5.Pedicle screw fixation, nonsegmental, l4-s1 with mdt sexton system.Procedure: a facetectomy at the l4-l5 level was performed unilaterally deroofing the exiting nerve root which was carefully protected the thecal sac and descending nerve root were retracted carefully.Using a 11 blade bard parker scalpel and annulotomy was created.Using a series of end plates shavers, curetes and rongeurs, radical discectomy was performed at this time.Cartilage was scraped from the end plates to expose bleeding subchondral bone.This was then mixed with local morselized bone graft and bone morphogenic carrier sponge.Next, a k2m an peek cage packed with bone graft was inserted into the disc space with distraction of the disc space.Posterolateral arthrodesis: the transverse processes are decorticated with high speed drill and then packed with morselized bone graft.The remaining facet joints were decorticated with a high speed drill and packed with bone graft.Local autograft bone was obtained from the drilling of the lamina as well as kerrison rongeur, was packed into the interspace together with bmp.On (b)(6) 2008, the patient presented with complaints of severe migraine headache and nausea.On (b)(6) 2008, the patient presented with a complaint of urinary retention.On (b)(6) 2009, the patient underwent ct scan of lumbar spine without contrast.Impression: obliteration of perineural fat right l4-l5 and l5-s1 neural foramen.There is lucency or lytic process in the right l5 lamina unchanged as well.Correlate with right-sided radiculopathy.On (b)(6) 2010, the patient underwent mri scan of spine lumbar with and without contrast, due to bilateral lumbar radiculopathy.Impression: satisfactorily postoperative appearance.There is no mr evidence of a complicating process.Spinal canal and neuroforamina are uncompromised.On (b)(6) 2011, the patient presented with posterior lumbar aching, posterior lumbar pain, right leg pain, right foot pain, right foot numbness and underwent lumbosacral imaging studies of ap lumbar spine and lateral lumbar spine.L4-s1 fusion with percutaneous rods; interbody graft; protruding rod, no decompression were detected.Diagnosis: degeneration lumbar/lumbosacral, post laminectomy syndrome lumbar and radiculopathy/radiculitis lumbar/thoracic.On (b)(6) 2012, the patient underwent ct scan of myelogram bone in neurofamina l5-s1 right ; long screws bilaterally and spect scan with hawkeye pseudoarthrosis l5-s1, due to radiating pain in lumbar: right leg(anterior and posterior), right foot and right buttocks.Diagnosis: lumbar ddd, radiculopathy, sciatica, stenosis.On (b)(6) 2012, the patient presented with the following pre-op diagnosis: postlaminectomy syndrome with spinal stenosis and pseudoa rthrosis, l4-s1.The patient underwent x-ray of single lateral portable view of the lumbar spine, due to back pain which was compared with ct scan of lumbar spine dated (b)(6) 2011.Impression: limited lateral view demonstrates apparent removal of posterior fusion hardware.The patient underwent the following procedure: complex revision of decompressive bilateral hemilaminectomy, l4, l5, s1 with removal of hardware with exploration of fusion with neurolysis with takedown pseudoarthrosis with posterolateral fusion, l4-5 and l5-s1 with allograft with bone marrow aspiration.A single incision was made over the spinous process of l4 to s1.Dissection was carried to the level of the spinous processes.A kocher was placed, and lateral x-ray was obtained for verification of level.During this time, paraspinal muscles were reflected out to the tips of the facet joint.Central decompressive revision bilateral hemilaminectomy was performed at l4-5 and s1.The patient was found to have severe lateral recess foraminal stenosis, which was causing significant nerve root compression and nerve root lateral root stenosis as well as intraforaminal bone fragments and ossification of the area where previous interbody fusion was contained.It appeared that some of the bone morphogenic protein material had leaked into the spinal canal and was causing significant nerve root compression at the 4-5 and 5-1 levels.Most significantly, there was significant hypertrophic bone on the right side and in the neural foraminal area of l5-s1.That nerve root was found to be completely encased in bone, and bone was growing up through the nerve root area.The nerve root was found to be tawny and brown in discoloration and severely compressed.Once it was completely decompressed, the osteophytectomy was performed as well as removal of the osteophytes coming from the disk space with a 1/4 inch chisel.Foraminotomy was then performed, and the lateral recesses were completely decompressed.At the termination of decompression, there was no evidence of any residual nerve compression.The wound was than copiously irrigated, and once this was completed, the bone marrow aspiration was performed with allo/autograft and placed over decorticated transverse processes at l4-5 and l5-s1.On (b)(6) 2012, the patient underwent x-rays of the chest in acute abdominal series exam.Impressions: there is a moderate regional ileus within right side of the abdomen.Evidence of a previous cholecystectomy was detected.On (b)(6) 2012, the patient presented with low back pain hot and burning, bilateral leg tightness and squeezing, left constant, right intermittent numbness both legs and left feet.The current medication was checked, past x-rays were reviewed and there was no evidence of instability.On (b)(6) 2012, the patient underwent lumbar x-ray ap and lateral, due to radiating pain in lumbar, left leg (anterior and posterior) and left foot.Diagnosis: lumbar degenerative disk disease, herniated nucleus pulposus, post-laminectomy syndrome, radiculopathy, sciatica.On (b)(6) 2012, the patient underwent mri of the lumbar spine with contrast.Impression: postoperative changes were again apparent with fusion at l4-l5 and l5-s1.There was scarring apparent in the neural foramina of l4-l5 and l5-s1 on the right.2.There had been removal of the pedicle screws and hardware since (b)(6) 2011.On (b)(6) 2012, the patient came for an office visit and presented with lower back pain and left thigh pain.On (b)(6) 2012, the patient underwent ct scan and lumbar x-ray ap and lateral, due to radiating pain in lumbar, right hip, right leg (lateral) and right foot.Diagnosis: lumbar: post-laminectomy syndrome, radiculopathy and status post fusion.On (b)(6) 2012, the patient underwent ct of the lumbar spine due to lower lumbar fusion with posterior decompression.Impression: 1.Bony fusion across the disc spaces of the l4-l5 and l5-s1.2.Posterior decompression with partial right-sided facetectomies l4-l5 and l5-s1 levels.3.Persistant posterior fluid collection within the unroofing site, unchanged in size when compared with the previous mri.On (b)(6) 2012, the patient underwent pelvic ultrasound w/o doppler for unspecified ovarian cyst.Impression: 1.Status post hysterectomy.2.Ovaries not visualized 3.No adnexal masses or free fluid identified.On (b)(6) 2013, the patient underwent pap test of the cervix.Interpretation: negative for intraepithelial lesion and malignancy.On (b)(6) 2013, the patient presented with complaints of migraine, nausea and vomiting.Diagnoses: a.Lumbar post-laminectomy syndrome b.Pseudoarthrosis of lumbar spine c.Degenerative disc disease d.Lumbar radiculopathy e.Sciatica f.Lumbar spinal stenosis.Impression: 1.Migraine 2.Sinus pressure and congestion.The patient underwent ct scan of the head/brain without contrast due to headache.Impression: 1.No acute intracranial hemorrhage or other acute intracranial process.2.Opacification of the sphenoid sinuses.On (b)(6) 2013, the patient underwent bone scan of the whole body for active osseous process evaluation.Impression: 1.The activity surrounding the intervertebral disc spacer devices and l4/l5 and l5/s1 may be postsurgical in nature, although pseudarthrosis cannot be excluded.2.Asymmetrical narrowing of the right neural foramina of the l5/s1, which may account for the patient's radicular pain.3.Minimal to mild activity surrounding the allograft material in the posterior elements of the l4-s1 and the tracts of the removed pedicular screws, this is favored to be within normal limits for a patient who is less than one year post-op.On (b)(6) 2013, the patient presented with bilateral back pain and right posteriolateral thigh pain as well as pain in right foot.Diagnostics addressed: 1.Sacroilitis.2.Bursitis: hip/trochanteric.3.Thoracic/lumbosacral neuritis/radiculitis unspec.4.Postlaminectomy syndrome lumbar region.New diagnoses: 1.Sacrolitis.2.Bursitis: hip/trochanteric.On (b)(6) 2013, the patient presented with pain in lower back with radicular symptoms in right leg.On (b)(6) 2013, the patient presented with back pain and bowel incontinence.The patient underwent x rays of the lumbosacral spine for fecal incontinence.Impression: noacute traumatic process.The patient also underwent mri of the lumbar spine with and without gadolinium.Impression: 1.Stable mri of the lumbar spine without with surgical changes and no evidence of the central canal stenosis, epidural abscess, or discitis.2.Stable mild narrowing of the right neural foramina at l4-l5 and l5-s1.On (b)(6) 2013, the patient consulted for lumbar myelogram with the following pre-op diagnosis: pain, post laminectomy syndrome.I mpressions for lumbar myelogram: postoperative changes secondary to the fusion at l4-l5 and l5-s1.Nothing to indicate spinal stenosis or disc herniation.The patient also underwent ct of the lumbar spine post myelogram due to back pain.Impression: postoperative changes of the lower lumbar spine as seen on the prior ct scan of (b)(6) 2012.There was no neuroforaminal stenosis or central canal stenosis at any level.No disc herniation was present.On (b)(6) 2013, the patient underwent x rays of the complete lumbosacral spine due to arthrodesis.Impression: stable lumbosacral spine with postsurgical changes at l4-l5 and l5-s1.2.No acute osseous abnormality.On (b)(6) 2013, the patient underwent x rays of the chest due to cough, other pulmonary embolism and infraction.Impression: normal chest x-ray.On (b)(6) 2013, the patient underwent bone scan whole body with spect, due to persistent lower back pain radiating down the bilateral lower extremities which was compared with spect/ct done on (b)(6) 2013.Impression: 1.There is no definitive scintigraphic evidence of pseudoarthrosis.2.Findings are concerning for post-surgical of inflammatory changes involving l4 to s1, more prominent at the right side of l5/s1, essentially stable since the prior bone scan/spect-ct of (b)(6) 2013.Clinical correlation and further followup is recommended at the discretion of the referring physician.On (b)(6) 2013,the patient underwent whole body bone scan with flow due to complaints of persistent lower back pain radiating down the bilateral lower extremities.Impression: 1.There was no definitive scintigraphic evidence of pseudoarthrosis.2.Findings were concerning for post-surgical or inflammatory changes involving l4 tos1, more prominent at the right side of the l5/s1, essentially stable since the prior bone scan of (b)(6) 2013.On (b)(6) 2013, the patient presented with pain in her back, into the buttock and right thigh.The radiographs were examined.Impression: postlaminectoy syndrome with radiculopathy, questionable permanent nerve damage.On (b)(6) 2014, the patient underwent bilateral mammography screening for ascertaining malignancy.Impression: negative for malignancy.On (b)(6) 2014, the patient presented with headache, left arm numbness and left leg numbness.The patient underwent ct scan of the head/brain without contrast.Impression: no acute intracranial process.Sinus mucosal disease.This had been present previously.The patient also underwent complete cervical spine x rays.Impression: 1.No acute osseous abnormality of the cervical spine.2.Mild degenerative changes greatest at the c5-c6 disc space.In addition, the patient underwent x-rays of the lumbosacral spine for left leg pain and weakness.Impression: no acute osseous abnormality of the lumbosacral spine.On (b)(6) 2014, the patient presented with persistent pain in her low back with severe radiation down the right leg.Impressions: p ostlaminectomy syndrome with radiculopathy.On (b)(6) 2014, the patient underwent mri scan of the lumbar spine with and without contrast, due to back ache, status post decompression and fusion.Impression: 1.Redemonstration of post surgical changes at l4-5 and l5-s1 with laminectomy changes, screw holes from previous pedicle screws, intervertebral disc space devices, and a persistent extradural fluid collection that shows no significant change in size.2.Mild neural foraminal narrowing on the right at the levels of l4-l5 and l5-s1, unchanged from prior exam.The patient also underwent bone scan limited spect with or without flow, due to back pain.Impression: 1.Increases activity in the s1 superior end plates laterally with the fixation hardware being more midline and to a lesser extent at the l4-l5 endplate junction, also seen laterally with the fixation centrally, not consistent with pseudoarthrosis.Slight interval increase in radiotracer activity in the l4-l5 endplate interface laterally on the left of unknown significance.2.Increased uptake in the right l3-l4 facet in a pattern most consistent with degenerative type activity.
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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) 2008: patient underwent bilateral mammogram screening.(b)(6) 2008: patient underwent ultrasound of breast (unilateral and bilateral) and mammogram, right.Impression: no mammographic evidence of malignancy.Recommended follow-up mammogram in one year.On (b)(6) 2008, patient underwent mri of lumbar spine.Impression: lesion in the l1 vertebral body of uncertain etiology.Further evaluation including bone scan as well as follow-up mri of lumbar spine with contrast in approximately three months is recommended.Mild degenerative disc disease with small annular tears at l4-5 and l5-s1.On (b)(6) 2008, patient presented for office visit with complaint of back and right leg pain.Patient underwent x-ray of lumbar spine.Impression: degenerative disc disease from l4 to s1.On (b)(6) 2008, patient underwent ct of pelvis without contrast.Impression: no acute obstructive uropathy.On (b)(6) 2008: patient underwent ct of head w/o contrast.Impression: there is no evidence of acute intracranial abnormality.On (b)(6) 2008, patient presented for follow-up to discuss treatment options.Patient reported right leg and back pain.On (b)(6) 2008, patient presented for evaluation of discogram.Patient reported low back pain and right lower extremity pain.On (b)(6) 2008 patient was diagnosed with the following: post laminectomy syndrome discogenic back pain degenerative disc disease from l4 to5 4) annular tear at l4-5 and l5-s1 5) central disc herniation at l4-5 and l5-s1 6) lesion t12/l1, benign.On (b)(6) 2008 patient's mri of (b)(6) 2008 was re-reviewed.It demonstrated degenerative disc disease with annular tear and central disc herniation at l4-5 and l5-s1.There was a scar tissue present at l4-5.There was a lesion at t12-l1.On (b)(6) 2009, patient presented for post-op follow-up.Patient reported squeezing sensation on right leg.Patient underwent x-ray of lumbar spine.Impression: percutaneous lumbar laminectomy and fusion from l4-s1.On (b)(6) 2009, patient underwent mri of lumbar spine w and w/o contrast.Impression: finding consistent with postoperative changes without evidence of significant central canal stenosis.On (b)(6) 2009, patient presented for post-op follow-up.Patient reported neuropathic right leg pain.Patient underwent x-ray of lumbar spine.Impression: percutaneous lumbar laminectomy and fusion from l4-s1.On (b)(6) 2009, patient underwent ct of lumbar spine.Impression: postsurgical changes are identified.Soft tissue changes are noted at l4-5 and l5-s1 with right neural foraminal encroachment suspected.There may be nerve root impingement.Again, the sensitivity of differentiating soft tissue density within the neural foramina from different tissue types is limited.On (b)(6) 2009, patient underwent mri of brain with and without contrast.Impression: 6mm enhancing lesion, peripheral left convexity most likely representing on incidental meningioma.This was not present on (b)(6) 2003 study.No hydrocephalus, ventricular shifting, or acute intracranial pathology.No evidence of trigeminal neuroma.Patient underwent magnetic resonance angiography.Impression: no aneurysm.On (b)(6) 2009, patient presented for evaluation of mri of brain.On (b)(6) 2009, postsurgical changes are identified.Soft tissue changes are noted at l4-l5 and l5-s1 with right neural foraminal encroachment suspected.There may be nerve root impingement.Again, the sensitivity of differentiating soft tissue density within the neural foramina from different tissue types is limited.On (b)(6) 2009 patient presented for evaluation of mri of brain and ct scan of the lumbar spine.Impression: percutaneous lumbar laminectomy and fusion from l4-s1 (2) left-sided frontal meningioma measuring approximately 0.6 mm (3) bilateral sl joint dysfunction (b)(6) 2009, patient presented for evaluation of imaging study.On (b)(6) 2009: patient underwent ct of abdomen and pelvis with contrast.Impression: postoperative changes to the lower lumbar spine.Post cholecystectomy changes.Small bilateral renal cysts.No evidence for obstruction.On (b)(6) 2009, patient presented for office visit with complaints of pain, decreased flexibility, decreased functional ability, decreased rom, and increased soft tissue tone which aggravate with bending, rising, squatting and twisting.On (b)(6) 2009: patient underwent x-rays of the abdomen.Impression: there are mild gas-distended bowel loops with air-fluid levels, which can be due to small obstruction.A follow-up study is recommended.On (b)(6) 2009: the patient underwent mammogram screening bilateral.On (b)(6) 2010: patient underwent ct of the abdomen with contrast, ct of pelvis with contrast.Impression: no obstruction, abscess of free air.Small bilateral renal cysts.Post cholecystectomy.There are postoperative changes of the spine.Patient underwent x-ray of abdomen.Impression: nonspecific air fluid levels in the right lower quadrant.Correlation with ct scan abdomen and pelvis recommended.On (b)(6) 2010: patient underwent ct of head without contrast.Impression: there is no evidence of intracranial abnormality.Patient underwent procedure for lumbar puncture under fluoroscopic guidance.On (b)(6) 2011: patient underwent ct of head without contrast.Impression: there is no evidence of intracranial abnormality.On (b)(6) 2014: patient underwent ct of head without contrast.Impression: no acute intracranial hemorrhage or major vessel territory infarct.Patient underwent x-ray of chest.Impression: no acute intrathoracic disease.On (b)(6) 2015, patient underwent ultrasound of abdomen due to abdominal pain/epigastric.Impression: benign right upper quadrant ultrasound.The common bile duct is obstructed after cholecystectomy.No right hydronephrosis nor shadowing stones are identified.Small right renal cysts are benign in appearance.On (b)(6) 2015: patient underwent x-ray of lumbar spine due to back pain.Impression: previous surgery in spine at level l4-5 and l5-s1.No acute process.Remainder of spine is normal.
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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 per patient fact sheet that: it was reported that: from 2000 to present: the patient underwent treatment due to back pain.From 2005 to present: the patient presented for back pain.In 2005, the patient underwent treatment of steroid injections.In 2006: the patient presented for labrum repair.From (b)(6) 2008 to 2009: the patient treated for bilateral disc herniation.From (b)(6) 2008 to 2009: the patient treated for back pain.On (b)(6) 2008: the patient underwent posterior lumbar interbody fusion at l4-s1 due to bilateral disc herniation with discogenic back pain, l4-l5 and l5-s1.K2m 12mm cage; set screws; screws; rod were also implanted.In 2010: the patient underwent physical therapy.In 2011: the patient underwent pain injections.From (b)(6) 2011 to 2013: the patient presented with lumbar pain and revision surgery.From 2012 to present: the patient underwent caudal epidural injections.In (b)(6) 2012: the patient presented with blood clot.On (b)(6) 2012: the patient underwent revision l4-s1, removal of hardware with exploration of fusion.On (b)(6) 2013: the patient presented with bowel/bladder incontinence, pain, right leg weakness.On (b)(6) 2014: the patient presented with migraine, left arm numbness.In 2014: the patient presented with pain.Allegedly, after the rh-bmp2/acs surgery, injuries include, but are not limited to bone growth, extreme pain, bowel and bladder incontinence, muscle spasms in back, pain down right leg with weakness, difficulty walking and standing for longer periods of time, difficulty lifting heavy objects during physical activities, implant site seroma, nerve injury, radiating leg pain, additional surgery to correct problems with rh-bmp2/acs, renal calculi, mental anguish/depression.
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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)2002 the patient was presented for office visit with dry cough, sore throat.Diagnosis: sinusitis, migraine.On (b)(6) 2002 the patient was presented for office visit with migraine.On (b)(6) 2002 the patient was presented for office visit with low grade fever and muscle aches.On (b)(6) 2002 the patient was presented for office visit with sinusitis.Diagnosis: migraine.On (b)(6) 2004 the patient was presented for office visit with back pain.On (b)(6) 2004 the patient was presented for office visit with back pain.Impressions: discogenic back pain l4-s1; lumbar disc herniation left l4-5; central disc herniation l5-s1.On (b)(6) 2004 the patient was presented for office visit with pain in her back and hip.On (b)(6) 2005 the patient underwent: left sacroiliac joint injection; left trochaitteric bursa injection; fluoroscopic guidance; conscious sedation.Preoperative diagnosis: left sacroiliac joint pain with lumbosacral spondylosis; left trochanteric bursitis.On (b)(6) 2005 the patient was presented for office visit with tailbone pain.Impressions: this began insidiously 3-4 months following l4-l5 laminectomy and diskectomy and l4-l5 disk herniation.Back pain and radicular pain from this completely resolved following the surgery.She also had left hip labraj.Tear, which was recently treated arthroscopically.On (b)(6) 2005 the patient was presented for office visit with cough, ear pain and face pain.Impressions: sinusitis.On (b)(6) 2005 the patient was presented for office visit with body aches and little cough.Diagnosis: sinusitis.On (b)(6) 2005 the patient was presented for office visit with coccydynia.Impressions: this is a (b)(6) woman with chronic coccydynia with good improvement from prior steroid injection.She is also status post l4-ls laminectomy and discectomy for disk herniation as well arthroscopic repair of hip labral tear.On (b)(6) 2005 the patient was presented for office visit with drowsiness and difficulty in concentrating.Impressions: increasing pain over the tailbone and buttock.It improved initially with injections at the coccyx.Then, she developed increasing pain in the left buttock.The most recent injection was at the left sacroiliac joint.She has an mri that suggests left parasacral abscess and myositis versus vascular abnormality.On (b)(6) 2005 the patient underwent ct scan of the lumbar spine.Impressions: no complication was reported.On (b)(6) 2005 the patient was presented for office visit with pain over the left buttock.On (b)(6) 2005 the patient was presented for office visit with persistent pain and fever.On (b)(6) 2005 the patient was presented for office visit with sinus, congestion and pressure on the right side.Diagnosis: infection.On (b)(6) 2005 the patient was presented for office visit with low grade fever, chills.Diagnosis: infection, osteomyelitis.On (b)(6) 2005 the patient was presented for office visit for a recheck up.Diagnosis: communicable disease.On (b)(6) 2005 the patient underwent ct scan of the head.Impressions: questionable linear area of increased attenuation in the left posterior temporal/parietal lobe.This may represent a venous angioma.Further evaluation with mri is recommended.On (b)(6) 2005 the patient underwent mri of the brain.Impressions: no complication was reported.On (b)(6) 2005 the patient was presented for office visit with pain in her abdomen.Diagnosis: diarrhea.On (b)(6) 2006 the patient was presented for office visit with pain in her tailbone and fever.On (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: no mr findings to suggest osteomyelitis/diskitis identified.These findings were discussed with dr.(b)(6) at the time of dictation.The patient has been scheduled for technetium white blood cell scan; postsurgical changes identified at the l4-5 level.No findings to suggest epidural fibrosis are identified.The patient¿s previous study has been requested.The patient will bring these films in next week for direct comparison; 2 cm cystic area identified right hemipelvis presumably ovarian in nature, suggestive of an ovarian cyst.If warranted, this could be further evaluated with sonography; signal abnormality in the li vertebral body which may represent atypical hemangioma.This will be correlated with the patient's prior study.On (b)(6) 2006 the patient was presented for office visit with pain in her buttocks.On (b)(6) 2006 the patient was presented for office visit with problem with p1cc line.On (b)(6) 2006 the patient was presented for office visit with pain in her back.On (b)(6) 2006 the patient was presented for office visit.She reported collapsing of leg.Impressions: coccygeal pain secondary to a history of osteomyelitis; right sacroiliac joint dysfunction; right anterior pelvic torsion; left osteitis pubis secondary to pelvic dysfunction; history of an l4-l5 laminectomy with right radiculopathy; right hip arthroscopy secondary to a right hip jabral tear; uterine fibroid tumor with menorrhagia.On (b)(6) 2006 the patient underwent mri of the pelvis.Impressions: mri of the pelvis without contrast.Examination demonstrates no evidence for osteomyelitis.Specifically, the bones of the pelvis are well-seen.The examination does not include the l3-l4 level; this will be included in patient's dedicated lumbar spine.There are two large fibroids within the uterus, one of which is anterior and exophytic measuring 4.4cm on series #2, image #13.A second small fibroid is seen in the body of the uterus and measljres 1.7cm.There is a small amount offree fluid in the pelvis which is compatible with this patient's age and reproductive status.No significant lymphadenopathy.Hips are normal.Otherwise, the examination is unremarkable.On (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: postoperative change from partial hemilaminectomy on the left at l4-5.There is adjacent surrounding soft tissue enhancement at the operative site.Low t1 signal within the inferior and posterior aspect of the spinous processes at l4 and l5 with corresponding enhancement within these locations following gadolinium contrast.Findings are most compatible with the patient's history of osteomyelitis.No outside imaging is available for comparison to determine if this process is improving or progressing.Focal small areas oft2 hyperintensity with corresponding enhancement within the posterior disks at l4-5 and l5-s1.The l5-s1 area of enhancement is compatible with a small annular tear.The enhancement at l4-l5 could represent an annular tear or postoperative change.No evidence of disk space infection.Small benign hemangioma at t12 and a second larger area of t2 hyperintensity and corresponding t1 hypointensity within the l 1 vertebral body posteriorly, likely representing an atypical hemangioma.On (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: postoperative changes suggestive of a left l4-5jaminotomy.However, the osseous surgical changes are poorlydelineated and could be better assessed with ct if clinically warranted.Mild degenerative disk disease.Disk desiccation and broad-based disk bulges with annullar tears are present at l4-5 and l5-s1.These disk bulges create mild bilateral foramina! narrowing at their respective levels.Minimal disk bulges at the remaining lumbar levels do not create neural impingement.Moderate to severe facet degenerative changes at l5-s1 and moderate facet degenerative changes elsewhere within the lumbar spine.Small amount of dorsal epidural scar tissue at the left l4-5 operative site; however, no evidence of associated neural impingement.An approximately 2cm lesion of t1 and t2 prolongation involving the posterior aspect of the l 1 vertebral body is noted.This likely represents an atypical hemangioma.If there is high clinical suspicion for metastatic disease, ct could provide additional specificity regarding the nature of this lesion.Small characteristic t12 hemangioma.No definite evidence of signal abnormality within the spinous process of l4 and l5 to correlate with subsequent signal abnormality demonstrated on the mayo clinic mri scan of (b)(6) 2006.However, lack of fat-saturated images on the (b)(6) 2006 examination would reduce sensitivity for the detection of this signal abnormality on those exams.A subcentimeter t2 hyperintense lesion within the partially visualized left renal cortex may represent a parenchymal cyst but is too small to characterize.Subsequent mayo clinic mri (b)(6) 2006 demonstrates apparently new foci of t1 and t2 signal prolongation with enhancement within the l4-5 and l5-s1 spinous processes.This is suggestive of marrow edema and may be related to the clinical history of ostemyelitis.However, lack of fat saturation on the (b)(6) 2006 examination significantly impairs comparison of the two exams.On (b)(6) 2006 the patient underwent bilateral ischial bursa injection and pericoccyx trigger point injection.On (b)(6) 2006 the patient was presented for office visit.Final diagnosis: chronic low back pain status post l4-5 laminectomy; history of osteomyelitis, undefined microbiology; allergy to beta lactums penicillin and cephalosporin.On (b)(6) 2006 the patient underwent caudal epidural steroid injection under fluoroscopy guidance.On (b)(6) 2006 the patient underwent caudal epidural steroid injection under fluoroscopy guidance.On (b)(6) 2010 the patient was presented for office visit for follow up.On (b)(6) 2010 the patient underwent mri of the brain.Impressions: there was no acute intracranial process; a 6 mm left frontal meningioma and was unchanged; an 8 mm pineal cyst was also similar; small air-fluid level was identified in the left sphenoid sinus.Correlate for acute sinusitis.On (b)(6) 2010 the patient underwent mri of the brain.Impressions: 6mm left frontal meningioma; 8mm pineal cyst; the remaining portions of the examination are normal.On (b)(6) 2010 the patient was presented for office visit with congestion.On (b)(6) 2011 the patient was presented for office visit with weakness.On (b)(6) 2011 the patient was presented for office visit with pain.On (b)(6) 2011 the patient underwent mri of the brain.Impressions: there was no acute intracranial process; a 6 mm left frontal meningioma and was unchanged; an 8 mm pineal cyst is also similar; small air-fluid level was identified in the left sphenoid sinus (b)(6) 2011 the patient was presented for office visit with right side pain, vomiting and sharp pain.On (b)(6) 2011 the patient was presented for office visit with left ear pain.Diagnosis: otalgia due to sinusitis.On (b)(6) 2011 the patient was presented for office visit with headache.On (b)(6) 2011 the patient was presented for office visit with migraine.On (b)(6) 2011 the patient was presented for office visit for follow up after enrolling in the premium trial.On (b)(6) 2012 the patient was presented for office visit for migraine medications checkup.On (b)(6) 2012 the patient underwent x-rays of the lumbar spine.No complication was reported.On (b)(6) 2012 the patient was presented for office visit.Impressions: acute pulmonary embolism; status post low back surgery; anemia of acute blood loss; history of patient foramen ovale, status post-surgical repair; migraine headache.On (b)(6) 2012 the patient was presented for office visit with left knee pain.On (b)(6) 2012, the patient underwent mri of the lumbar spine with contrast.Impression: postoperative changes were again apparent with fusion at l4-l5 and l5-s1.There was scarring apparent in the neural foramina of l4-l5 and l5-s1 on the right; there had been removal of the pedicle screws and hardware since (b)(6) 2011.The patient was also presented for office visit with pain in her hip.On (b)(6) 2012 the patient was presented for office visit with migraine.On (b)(6) 2012, the patient came for an office visit and presented with lower back pain and left thigh pain and depression.On (b)(6) 2012 the patient was presented for office visit with right side pain, fever, chills.On (b)(6) 2012 the patient underwent ct scan of abdomen and pelvis.Impressions: there were no urinary tract calculi identified.The right renal pelvis is somewhat larger than on the prior study.This could reflect-an extrarenal pelvis though typically this would have been on the prior study as well.Therefore, another consideration would be a recently passed stone; there is a 3cm cyst within the right adnexa.This has a different appearance than on the prior study and presumably is new.Follow-up pelvic ultrasound could be obtained if this is felt to be the cause of the symptoms; removal of spinal fusion hardware with laminectomy defects.There was a fluid collection within the surgical bed which appears to be outside the thecal sac as seen on this examination.If there were lumbar spine symptoms or headaches, then an mri of the lumbar spine was recommended for further evaluation; prior cholecystectomy; there are multiple renal lesions, some of which are too small to characterize though statistically these likely represent cysts and some of these presumed cysts are new since the previous examination.On (b)(6) 2012 the patient was presented for office visit with right flank pain.Impressions: right flank pain with mild fullness on ct scan.On (b)(6) 2012 the patient was presented for office visit with pain primarily in her low back with radicular symptoms in her right leg, spasm of muscle, radiculitis, post laminectomy syndrome lumbar region, lumbar intervertebral disc.On (b)(6) 2013 the patient was presented for office visit with sore throat and sinus issues.On (b)(6) 2013 the patient was presented for office visit.Impressions: migraine, sinus pressure and congestion, lumbar post laminectomy syndrome, peudoarthrodesis of lumbar spine, disc degenerative disease, lumbar radiculopathy.On (b)(6) 2013 the patient was presented for office visit with pain in her lower back with radicular symptoms in her right leg.The patient describes this pain as aching, throbbing, cramping, twisting.Assessments: depression, thoracic/lumbosacral neuritis, post laminectomy syndrome lumbar region.On (b)(6) 2013 the patient was presented for office visit with low back pain radiating down right leg.Impressions: sacrolitis, thoraci c/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region.On (b)(6) 2013 the patient was presented for office visit for neurological follow up.On (b)(6) 2013 the patient was presented for office visit with lower back pain radiating into the buttocks and the right calf.Impressions: sacrolitis, thoracic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine.On (b)(6) 2013 the patient was presented for office visit with chest pain.On (b)(6) 2013 the patient was underwent x-rays of the lumbar spine.Impressions: diffuse osteo penis.Post-surgical changes consistent with interbody fusion and laminectomy at the l4-5 and l5-s1 levels.Fusion appears mature without evidence of failure.On (b)(6) 2013 the patient underwent mri of the lumbar spine.Impressions: stable mri of the lumbar spine without with surgical changes and no evidence of central canal stenosis, epidural abscess, or discitis; stable mild narrowing of the right neural foramina at l4-l5 and l5-s1 on (b)(6) 2013, the patient was presented for office visit with pain in lower back and leg, insomnia.On (b)(6) 2013 the patient was presented for office visit with sinus infection.On (b)(6) 2013 the patient was presented for office visit with low back pain radiating down bilateral leg.Impressions: sacrolitis, tho racic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine, insomnia, (b)(6) 2013 the patient was presented for office visit with flank pain, abdominal pain and nausea.On (b)(6) 2013 the patient was presented for office visit with pain in her right side.On (b)(6) 2013 the patient underwent ct scan of the abdomen and pelvis.Impression: interval development of punctuate bilateral renal calculi.There is no urinary tract obstruction.No ureteral calculi or urinary bladder calculi demonstrated; the right adnexal lesion on the prior study has resolved and it was probably an ovarian cyst; the post-surgical appearance of the spine is unchanged with removal of hardware, interbody graft material and facet arthrosis.The fluid collection within the surgical bed posterior to the thecal sac has slightly decreased in size since the prior study; there are multiple renal lesions as before which are unchanged.Statistically these are likely cysts but too small to accurate characterize.The stability since prior exam favors benign etiology.On (b)(6) 2103 the patient underwent x-rays of the abdomen.Impressions: suboptimal study due to retained contrast throughout the colon which obscures the kidney and ureters.On (b)(6) 2013 the patient was presented for office visit with low back pain radiating down bilateral leg.Impressions: sacrolitis, tho racic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine, insomnia, (b)(6) 2013 the patient was presented for office visit with low back pain radiating down bilateral leg.Impressions: sacrolitis, tho racic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine, insomnia, (b)(6) 2013, (b)(6) 2014, the patient was presented for office visit with low back pain radiating down bilateral leg.Impressions: sacrolitis, thoracic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region, migraine, insomnia, questionable permanent nerve damage.On (b)(6) 2013 the patient underwent ct scan of the abdomen pelvis.Impressions: no obstructing calculus seen; mild amount of fecal retention; no acute abnormality identified.On (b)(6) 2014 the patient underwent ct scan of the head or brain.Impressions: incidental probable pineal cyst.Otherwise unremarkable examination of the brain.On (b)(6) 2014 the patient was presented for office visit with burnt back due to heating pad.On (b)(6) 2014 the patient was presented for office visit with migraine.On (b)(6) 2014 the patient was presented for office visit with sore throat.On (b)(6) 2014 the patient was presented for office visit with lower back pain and right anterior thigh/ knee pain.Impressions: sacrolitis, thoracic/lumbosacral/radiculitis.Postlaminectomy syndrome in lumbar region.On (b)(6) 2014 the patient was presented for office visit with lump/ rash on left leg.On (b)(6) 2014 the patient was presented for office visit with congestion, sore throat and dry cough.On (b)(6) 2014 the patient was presented for office visit with migraine.On (b)(6) 2015 the patient was presented for office visit with sleep disturbances.On (b)(6) 2015 the patient was presented for office visit with migraine.On (b)(6) 2015 the patient underwent x-rays of the abdomen.Impressions: moderate stool is scattered throughout the colon.Single view abdomen examination otherwise appears normal as detailed above.On (b)(6) 2015 the patient was presented for office visit for evaluation for connective tissue disease previous positive ana.Assessments: positive ana, other and unspecified nonspecific immunological findings.On (b)(6) 2015 the patient was presented for office visit for test results.On (b)(6) 2015 the patient was presented for office visit with sinusitis and sore throat.On (b)(6) 2015 the patient was presented for office visit for urological care for renal calculi.Assessments: kidney stone; back pain; gross hematuria.On (b)(6) 2015 the patient was presented for office visit with rashes.On (b)(6) 2015 the patient was presented for office visit with nausea, vomiting, migraine headache, abdominal pain.Assessments: nausea with vomiting; abdominal pain, internal hemorrhoids without mention of complication; irritable bowel syndrome.On (b)(6) 2015 the patient was presented for office visit with back pain, hip pain.The patient also underwent intramuscular injection of steroid.On (b)(6) 2015 the patient was presented for office visit with joint ache and sore throat.On (b)(6) 2012 patient presented with lumbar spondylolisthesis.
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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 on (b)(6) 2005, the patient was admitted for chronic osteomyelitis of vertebra.On (b)(6) 2005, the patient underwent the following procedure: venous catheterization.On (b)(6) 2005, the patient was discharged.On (b)(6) 2008: the patient presented with back pain radiating down the right leg.On (b)(6) 2008, the patient was discharged with the following diagnoses: degenerative lumbar disc; acute blood loss anemia; migraine headache; urinary retention.On (b)(6) 2013, the patient presented with kidney stones.
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