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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
Ossification (1428); Chest Pain (1776); Fever (1858); Headache (1880); Hearing Loss (1882); Incontinence (1928); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Swelling (2091); Weakness (2145); Burning Sensation (2146); Dysphasia (2195); Stenosis (2263); Injury (2348); Osteolysis (2377); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Sleep Dysfunction (2517); 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 spine fusion surgery on the lumbar region of her spine from l3-l5 using rhbmp-2/acs.Reportedly, the patient's post-op period was marked by increasingly severe pain that radiates to her legs.The patient has developed pain that radiates into her lower extremities that stems from uncontrolled bone growth and osteolysis following the surgery.
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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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Manufacturer Narrative
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(b)(4).
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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) 1988, patient presented with pelvic pain.Patient underwent hysterectomy and incidental appendectomy for a pre-op diagnosis of leiomyomata of the uterus with menorrhagia.On (b)(6) 1990, patient underwent bilateral salpingo-oophorectomy for a pre-op diagnosis of right ovarian cyst.On (b)(6) 2000 patient underwent x-ray of chest.Impression: bibasilar pulmonary infiltrates (right greater than left).This finding may reflect pneumonia, or possibly aspiration.Clinical correlation is recommended.On (b)(6) 2000, patient presented with chest discomfort.Patient underwent ultrasound of abdomen.On (b)(6) 2000, patient underwent esophagogastroduodenoscopy.No complications were reported during the procedure.On (b)(6) 2001: patient underwent lumbar steroid epidural injection.On (b)(6) 2001, patient underwent mri of spine for low back pain.Impression.An apparent right laminotomy defect is present at l5-s1 level.Correlation with surgical history is recommended.There is a very mild (grade i) retrolisthesis of l5 on s1.Mild posterior disc bulging is present with no evidence of hnp, neural foraminal compromise, or nerve root impingement, or enhancing scar formation.At l4 ,5 level, there is a very mild (grade i) anterolisthesis which is also likely 'degenerative in origin.No definite enhancing scar formation, hnp, or neural foramina compromise is present.At l3-4 level, there is a posterior disc bulge, but no evidence of hnp, neural foramina' compromise or nerve root impingement.Questionable enhancement posteriorly at l3-4 level seen on sagittal post contrasted images is of uncertain etiology given apparent lack of prior surgery at his level.Correlation with surgical history is therefore recommended.There is no other evidence of hnp, neural foraminal compromise or nerve root impingement.On (b)(6) 2001, patient underwent lumbar epidural steroid injection.On (b)(6) 2002: patient underwent x-ray chest.Impression: no evidence of acute cardiopulmonary disease.On (b)(6) 2002: patient underwent lumbar steroid epidural injection.On (b)(6) 2002: patient underwent mri right knee.Impression: focal abnormally increased signal in the central portion of the posterior horn medial meniscus is felt to represent intrasubstance degeneration of the meniscus.This signal does not contact an articular surface and therefore does not represent a complete tear.On (b)(6) 2002: patient underwent egd.Patient underwent colonoscopy.On (b)(6) 2002: patient underwent x-ray chest.Impression: negative chest.On (b)(6) 2001, patient underwent mri of spine for low back pain.Impression.An apparent right laminotomy defect is present at l5-s1 level.Correlation with surgical history is recommended.There is a very mild (grade i) retrolisthesis of l5 on s1.Mild posterior disc bulging is present with no evidence of hnp, neural foraminal compromise, or nerve root impingement, or enhancing scar formation.At l4 ,5 level, there is a very mild (grade i) anterolisthesis which is also likely 'degenerative in origin.No definite enhancing scar formation, hnp, or neural foramina compromise is present.At l3-4 level, there is a posterior disc bulge, but no evidence of hnp, neural foramina' compromise or nerve root impingement.Questionable enhancement posteriorly at l3-4 level seen on sagittal post contrasted images is of uncertain etiology given apparent lack of prior surgery at his level.Correlation with surgical history is therefore recommended.There is no other evidence of hnp, neural foraminal compromise or nerve root impingement.On (b)(6) /2001, patient underwent lumbar epidural steroid injection.On (b)(6) 2002: patient underwent x-ray chest.Impression: no evidence of acute cardiopulmonary disease.On (b)(6) 2002: patient underwent lumbar steroid epidural injection.On (b)(6) 2002: patient underwent mri right knee.Impression: focal abnormally increased signal in the central portion of the posterior horn medial meniscus is felt to represent intrasubstance degeneration of the meniscus.This signal does not contact an articular surface and therefore does not represent a complete tear.On (b)(6) 2002: patient underwent egd.Patient underwent colonoscopy.On (b)(6) 2002: patient underwent x-ray chest.Impression: negative chest.On (b)(6) 2002: patient underwent x-ray ankle.Impression: unremarkable right ankle films.No evidence of fracture.On (b)(6) 2002: patient underwent mri lumbar spine.Impression: probable small enhancing disk protrusion at 3-4 on the right not significantly changed from prior examination and without evidence for compression.Degenerative facet changes diffusely.However most severe 4-5 with some fluid within this facet joint on the right.On (b)(6) 2003: patient underwent x-ray chest.Impression: no evidence of acute cardiopulmonary disease.On (b)(6) 2003: patient underwent ct pelvis.Impression: no definite evidence of hydrorephrosis in either kidney or ureterectasis.A tiny calcification is noted in the lower pole of the kidney.A calcification at the approximate lower level of the right "ujv" present which may represent a phlebolith, although a distal right ureteral calculus cannot be excluded.If clinically indicated, additional evaluation with ivp could be obtained to exclude the presence of a non-obstructing distal right ureteral calculus at this level.On (b)(6) 2003: patient underwent mri lumbar spine.Impression: probable prior right laminotomy defect at l5-s1 and l4-5 levels.Correlation with prior surgical findings is recommended.No enhancing scar formation is present following contrast administrator.Disk desiccation is noted at l3-4, l4-5 and l5-s1 levels.There is broad based posterior disc bulging at l5-s1 and to a lesser degree at l4-5 level.A mild degenerative anterolisthesis is noted on l$ and l5.A small focus of bright t2 weighted signal present posteriorly at l3-4 level is noted which likely represents a very small subligamentous "hnp", but there is no neural foraminal compromise or spinal stenosis identified.No other interval change noted.On (b)(6) 2003: patient underwent mri of the left ankle.Impression: the localized inflammatory change in with the epicenter at the os trigonum is compatible with os trigonum syndrome.The appearance of the achilles tendon is compatible with chronic tendonitis.No acute abnormality of the achilles tendon is seen.On (b)(6) 2003: patient underwent mri cervical spine.Impression: very small posterior midline protrusion of the c4-5 disc of questionable significance.Otherwise the mri of the cervical spine is unremarkable.On (b)(6) 2003: patient underwent abdomen x-ray.Impression: negative for evidence of obstruction or free air.No acute cardiopulmonary disease.On (b)(6) 2004: patient underwent right shoulder mri.Impression: a small focus of bright t2 weighted signal is present along the under surface of the distal aspect of the supraspiratus tendon which may represent a partial under surface tear or tendinopathy.No definite full thickness tear or susculotendinous retraction is noted.On (b)(6) 2004: patient underwent surgery for right shoulder rotator cuff tear with flap tear.On (b)(6) 2004: patient underwent head ct without contrast.Impression: negative unenhanced ct of the brain.On (b)(6) 2004: patient presented for follow up with minimal discomfort in the shoulder.Patient had minimal tenderness.Patient had mild weakness with resistive shoulder elevation.On (b)(6) 2004: patient underwent mri brain without contrast.Impression: modest white matter changes are non-specific in appearance, but chronic ischemic white matter change is more likely than demyelinating disease in a patient of this age.Is there a known history of chronic hypertension or diabetes? possible mass associated with a posterior pituitary.Although signal characteristics of the lesion suggests that this may be an incidental protonatious cyst, (for example rathxe cleft cyst) dedicated pituitary imaging would completely characterize.On (b)(6) 2004: patient underwent mri lumbar spine without contrast.Impression: degenerative disk disease, facet osteoarthritis and evidence of prior surgery on the right l5-s1.Bulging of the annular remnant and end plate proliferation are more severe on the right perhaps because there is a mild scoliosis.Disks, granulation tissue, and bone modestly posteriorly displace the traversing right s1 nerve root, but there is no neural impingement.End plate proliferation and disk bulging were also described in the report of the mri examination.Degenerative grade 1 spondylolisthesis at l4-5 and associated disk degeneration.There has also been prior surgery on the right on this level.There is only mild spinal canal narrowing.Degenerative disk disease at l3-4.There is a posterior annular fissure but no neural impingement.On (b)(6) 2004: patient was admitted for atypical chest pain likely non-cardiac.On (b)(6) 2004: patient was presented for a visit and reported chest pain and elevated liver enzymes.On (b)(6) 2004: patient underwent x-ray chest.Impression: no evidence of active disease.Patient also underwent ct abdomen and pelvis.Impression: bibasilar atelectatic changes.No acute process within the abdomen or pelvis.08 jan 2005: patient underwent mri thoracic spine with and without contrast.Impression: negative mri of the thoracic spine.On (b)(6) 2005: patient underwent ct brain without contrast.Impression: negative unenhanced ct of the brain.On (b)(6) 2005: patient was admitted with numbness on left side of face and body and chronic chest pain.Patient underwent mri brain with and without contrast.Impression: mild white matter disease, likely ischemic and due to small vessel disease, negative for acute/subacute intracranial ischemia.On (b)(6) 2005: patient presented with numbness on left side of face and body and headache with light headedness post stroke.On (b)(6) 2005: patient underwent mri brain with and without contrast.Impression: mild white matter disease, likely ischemic and due to small vessel disease.Negative for acute/subacute intracranial ischemia.On (b)(6) 2005: patient made a hospital visit with numbness on left side.On (b)(6) 2005: patient underwent x-ray chest.Impression: no acute pulmonary disease.On (b)(6) 2005: patient underwent right shoulder open rotator cuff repair and right shoulder anterior labral reconstruction.No complications were reported.On (b)(6) 2005 the patient underwent xrays of the chest.Impressions: no acute pulmonary disease.On (b)(6) 2005 the patient underwent mri of the brain.Impressions: mild white matter degenerative change, likely a reflection of chronic small vessel ischemic disease.Negative unenhanced brain mri exam.No findings of an acute or old cortical based cva.The patient also underwent mri of the lumbar spine.Impressions: suspect the previous surgical level is l5-s1.There are findings of diffuse bulge and severe left neural foraminal narrowing and mild right sided neural foraminal narrowing at this level.Severe facet degenerative change causes slight anterolisthesis of l4-5.There is moderate to severe right and minimal left neural foraminal narrowing at this level.At l3-4, diffuse bulge is identified as well as focal right lateral disc protusion.This moderately narrows the right neural foramen.L2-3 bulge without significant mass effect.The patient also underwent mri of shoulder.Impressions: severe rotator cuff tendinopathy involving the supraspinatus as well as infraspinatus contribution.The signal intensity is such that there could be more intrasubstance tearing as well, there is an insertional full thickness tear, involving approximately 1cm of the anterior aspect of the rotator cuff, supraspinatus contribution.There is no retraction or muscular atrophy.Mild ac joint degenerative change.Inferior glenoid change, could be hypertrophic and degenerative or possibly remotely post traumatic.On (b)(6) 2005 the patient underwent xrays of chest.Impressions: negative chest radiograph.On (b)(6) 2006 the patient also underwent mri of the brain.Impressions: minimal early degenerative white matter change the patient also underwent mri of the brain.Impressions: minimal early degenerative white matter change.On (b)(6) 2006 the patient was presented for office visit with pain mainly post prandial, associated with nausea without vomiting.Impressions: upper abdominal pain- gastritis, peptic ulcer disease, gastroparesis, adhesions from previous surgery, hypertension, diabetes, and biliary dyskinesia status post cholecystectomy.On (b)(6) 2006 the patient underwent mri of the lumbar spine.Impressions: post surgical changes at l4-5 and l5-s1.No evidence of disc extrusion at these levels.Disc bulges are present, along with bilateral foraminal narrowing.On (b)(6) 2006 patient also underwent xrays of the chest.No complication was reported.Also underwent ct scan of lumbar spine.Impressions: grade 1 spondylolisthesis at l4 on l5 vertebral body.Mild moderate ddd at l4-s1.There is no acute fracture.On (b)(6) 2007: the patient underwent xrays of the lumbar spine.Impressions: degenerative disc disease of the lumbar spine.On (b)(6) 2008, patient underwent ct of abdomen and pelvis due to epigastric and abdominal pain.Impression: no acute findings.On (b)(6) 2009: the patient was admitted for pain in her left arm.On (b)(6) 2010: patient was admitted for mid back pain.Pain was described as constant aching.On (b)(6) 2011: the patient was admitted to the hospital for pain in head left arm and left breast.On (b)(6) 2012: the patient was admitted.On (b)(6) 2012: the patient was admitted for chest pain, non-radiating without shortness of breath, nausea, vomiting, or diaphoresis.On (b)(6) 2012: the patient presented for chest pain, fatigue and malaise.On (b)(6) 2013: the patient presented for follow up.On (b)(6) 2013: the patient presented for follow up.Patient underwent ct head without contrast.Impression: negative for acute intracranial findings.Preliminary report issued contemporaneously by the (b)(6) time of study.On (b)(6) 2013: the patient was admitted for facial, neck, arm and leg numbness with left sided weakness.Patient underwent mri brain without contrast.Impression: no acute or subacute infarc demonstrated.Scattered foci of t2 and flair hyperintense signal involving the subcortical and deep white matter of both cerebral hemispheres are nonspecific and likely reflect minimal chronic small vessel white matter degenerative change or the sequel of chronic migraine headache.Otherwise unremarkable brain mri.Mild chronic inflammatory disease involving the left maxillary sinus.On (b)(6) 2013: the patient was admitted for facial numbness, left sided numbness of her upper left arm.On (b)(6) 2013: the patient was admitted with chest pain.On (b)(6) 2014: patient got hospitalized for eye pain.On (b)(6) 2014: patient got hospitalized for back pain radiating to up to her mid spine.On (b)(6) 2014: the patient underwent abdomen pelvis ct without contrast.Impression: punctate renal calculi unchanged.No hydrorephrosis or perirenal inflammatory changes.On (b)(6) 2015: the patient underwent ct of the abdomen and pelvis with contrast.Impression: etiology of the patient's abdominal pair is not definitely identified.Tiny non-obstructing right renal calculus.Hepatic stenosis.No acute inflammatory process or bowel obstruction is demonstrated.Status post fundoplicator, cholecystectomy, appendectomy and hysterectomy.Minimal sigmoid colon diverticulosis.On (b)(6) 2004 as per billing records patient underwent mri l-spine without contrast.On (b)(6) 2015 per billing records, patient presented for ct abdomen and pelvis scan.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per medical records, surgical approach used in procedure: posterior no other device was used; no cage was implanted other than rhbmp-2/acs.Patient reported that spinal stenosis l3-4, causing back pain led to her rh-bmp2 treatment.Post-op infuse treatment, patient suffered injuries including, difficulty breathing; osteoarthritis; radiating pain to the legs; ext reme pain; one leg was now longer than the other, cauda equina syndrome, difficulty speaking, pain more often that was before infuse surgery, bowel/bladder incontinence, renal calculi, localized edema, nerve injury, osteoarthritis, mental anguish/depression.The pain has led patient to depend on the aid of a walker and a cane.Since the onset of the severe back pain in 2011, she has been on constant pain medication.
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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) 2003: patient injured in car accident.(b)(6) 2003: patient presented with chronic lower back pain and bilateral knee pain.(b)(6) 2003: patient presented for reexamination of worsening lower back pain and pain into the posterior aspect of the right leg.Physical examination revealed moderate amount of paraspinous lumbosacral tenderness.(b)(6) 2003: patient presented with chronic lower back pain and left ankle pain, moderate amount of right shoulder pain.Physical examination revealed moderate amount of paraspinous lumbosacral tenderness.Straight leg raising is negative bilaterally in the seated position.Examination of the left ankle revealed a moderate amount of tenderness of the atf ligament region.Patient had a moderate amount of reproduced discomfort with forced plantar flexion and inversion.The ankle is mildly unstable to anterior drawer compared to the right.There is a moderately positive impingement sign and tenderness of the internal aspect of the shoulder.(b)(6) 2003: patient presented with chronic lower back pain, worsening neck pain and numbness into the right forearm.There was subjective decreased sensation along the medial aspect of the right forearm.(b)(6) 2003: patient presented with chronic neck pain and moderate amount of shoulder pain.Physical examination revealed limited motion of the neck lateral rotation head tilt and moderate amount of paraspinous cervical tenderness and moderate amount of diffuse right shoulder tenderness.Mri of the cervical spine revealed disc protrusion at c4 c5.(b)(6) 2003: patient presented with chronic neck pain, lower back pain and right shoulder pain.Patient recently underwent emg studies which were normal for the upper extremities with no evidence of cervical radiculopathy.Physical examination revealed limited motion of the neck lateral rotation head tilt and moderate amount of paraspinous cervical tenderness and mild to moderately positive impingement sign.(b)(6) 2004: patient presented with chronic multiple joint pains along with neck pain and right shoulder discomfort.Physical examination revealed moderate amount of right sided trapezius muscle tenderness.(b)(6) 2004: patient presented with lower back pain, neck pain.Physical examination revealed limited motion of the neck with lateral rotation head tilt.There was a mild amount of paraspinous cervical tenderness and moderate amount of paraspinous lumbosacral tenderness.(b)(6) 2004: patient presented with lower back pain, neck pain and worsening right shoulder pain.Physical examination revealed moderately positive impingement sign and mild to moderate amount of paraspinous cervical and lumbar tenderness.(b)(6) 2004: patient presented with recurrent moderate amount of right shoulder pain.Patient was having difficulties with above shoulder level use.There was moderately positive impingement sign.Physical examination revealed that there was a moderate amount of tenderness over the anterolateral aspect of the shoulder.Patient had full motion of the neck with lateral rotation head tilt and mild amount of paraspinous cervical tenderness.Mri of the shoulder revealed a partial thickness rotator cuff tear.(b)(6) 2004: patient presented with significant amount of shoulder pain and difficulties with above shoulder level use.She had minimal relief from the steroid injection.Patient was having mild amount of neck pain.Physical examination revealed mild amount of paraspinous cervical tenderness.There was moderately positive impingement sign.(b)(6) 2004, (b)(6) 2004: patient presented for follow up post operatively.(b)(6) 2004: patient presented with a lymph node on her right axilla.Physical examination revealed small nerve palpated in the axilla.(b)(6) 2004, (b)(6) 2004: patient presented for follow up post op from right rotator cuff repair.This had been complicated by superficial wound infection.(b)(6) 2004: patient presented for follow up with minimal discomfort in the shoulder.Patient had minimal tenderness.Patient had mild weakness with resistive shoulder elevation.(b)(6) 2004: patient presented with multiple joint pains along with low back pain and neck pain.Several months ago patient sustained a small left sided stroke leaving her with a mild right sided hemiplegia.Patient noted pain from the neck down to the tips of her fingers and weak shoulder.Physical examination revealed that cervical spine moved well but there was tenderness at the extremes of left and right tilt.(b)(6) 2005: patient presented for a pre-op for a revision right shoulder arthroscopy and possible rotator cuff tear.At the last visit a mri was ordered which demonstrated a possible recurrent partial thickness tear.(b)(6) 2005: patient underwent revision of right shoulder rotator cuff repair.(b)(6) 2005, (b)(6) 2005: patient presented for follow up post operatively.(b)(6) 2005: patient presented for follow up post operatively.Patient noted a growth underneath her right arm which was not painful.Patient had severely limited internal rotation.(b)(6) 2005: patient presented with recurrent low back pain.There was some tenderness to deep palpation and percussion over lumbar spine.Two radiographic views of the lumbar and thoracic spine are unremarkable except for an l4-l5 degenerative spondylolisthesis.(b)(6) 2005: patient presented for follow up post op from a revision right shoulder rotator cuff repair.Patient reported cervical spine pain, shoulder pain and low back pain.On examination, the cervical spine had tenderness.There was mild-to-moderate tendeness against resisted adduction.Lumbar spine was tender to any manipulation.(b)(6) 2005: patient presented with significant amount of cervical spine pain as well as some shoulder pain.Patient had mri which demonstrated a continued uptake at the rotator cuff insertion site.To doctor's review it was simply supraspinatus tendinopathy and not a recurrent tear.Physical examination revealed that patient's cervical spine had marked tenderness when taken through range of motion.(b)(6) 2009: patient presented with low back pain, neck pain and soreness on the knee.Patient was involved in aa and hit in the back.Patient underwent right knee x-ray which was negative.Patient underwent spine x-ray.(b)(6) 2009: patient presented with some soreness in the neck and back but was comparatively better.Physical review revealed that the rom of the back was limited in extremes of flexion and extension.(b)(6) 2010: patient presented with right shoulder pain.Patient had hard time sleeping at night.Previous mri showed arthroscopies on both shoulders.There was a lot of rotator cuff tendonitis.Patient had a slab tear.Physical exam revealed significant pain on the rotator cuff area.O'brien test was positive for pain.Lift off test was painful.External rotation was painful.Impingement test was painful which seemed to be tendonitis as per doctor.(b)(6) 2010: patient presented for follow up and underwent shoulder x-ray which showed significant impingement.Labrum was intact.Doctor did not rule out tear.Patient also had impingement coming from the ac joint.(b)(6) 2010: patient presented with soreness over ankle with no significant findings with some posteriorly.Per doctor, it seemed pe roneal tendonitis.Debridement of subacromial area was performed which looked good.(b)(6) 2011: patient presented with sore and numb feet and diabetes.Physical examination revealed absence of ankle jerk on both legs.Per doctor, toe and heel gait were possible and patient had polyneuropathy coming from her diabetes.Patient underwent back x-ray which showed degenerative listhesis at l4-l5 and multiple back surgeries.(b)(6) 2011: patient presented with multiple levels of disease on the lumbar spine with several spinal canal stenosis 3-4 and 4-5 with subluxation on 4-5.There was a lot of facet hypertrophy and herniation on l5-s1.Patient underwent emg which showed mostly chronic changes, mainly on the l5 root on the right side.No polyneuropathy.(b)(6) 2011: patient presented for follow up.(b)(6) 2011: patient underwent arthrodesis as per billing record.(b)(6) 2011: patient presented for follow up and doctor examined the wound which looked healed.Patient underwent lumbar spine x-ray.(b)(6) 2011: patient presented for follow up and underwent x-ray which looked good.(b)(6) 2012: patient presented for follow up and underwent lumbar spine x-ray which looked good but there was not much incorporation.Doctor found listhesis on 4-5 and there was plenty of bone graft posteriorly.(b)(6) 2012: patient presented with pain after spinal fusion.Patient underwent lumbar spine x-ray.Findings: it lookd good.The bone seems to be there.(b)(6) 2015: patient presented with complaints of right hand ring finger triggering.Patient reported that this had been going on for years now.It gets stuck in a downward position and patient has to force it to straighten it.Patient reported sleep apnea.Patient underwent trigger finger injection - right.There were no complications reported.(b)(6) 2011 the patient presented for an office visit due to lumbar spinal stenosis.The patient presented with posterior lumbar pain, right leg pain.Assessment: stenosis, lumbar spine; spondylolisthesis, acquired; diabetes mellitus.(b)(6) 2011 the patient presented for lumbar myelogram due to hnp and low back pain radiating down right leg to toes.(b)(6) 2011 the patient presented for follow up on his lumbar ct/myelogram, lumbar myelogram.(b)(6) 2011 the patient presented for pre operative discussion and she is still having much pain.(b)(6) 2011 the patient presented with the pre op diagnoses of 1.Lumbar canal stenosis and foraminal stenosis l2-3, l3-4 and l4-5.2.Pseudo spondylolisthesis at l4-5 which has been previously fused.The patient underwent the following procedures: 1.Partial l2, l3, l4, l5 laminectomies, medial facetectomies and foraminotomy 2.Arthrodesis of l4 and l3.No patient complications were noted.(b)(6) 2011 the patient was discharged from the hospital.(b)(6) 2011, (b)(6) 2011, (b)(6) 2012, (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014, the patient presented for postoperative recheck of laminectomy l2 bilateral, laminectomy l3 bilateral, laminectomy l4 bilateral, fusion (autograft).(b)(6) 2011 the patient presented for postoperative recheck of laminectomy l2 bilateral, laminectomy l3 bilateral, laminectomy l4 bil ateral, fusion (autograft) l3-5, fusion (autograft) l5-s1.The patient is in the immediate postoperative period.Overall, the symptoms have improved.(b)(6) 2011 the patient presented with the complaints of pain in hip area and down right leg.She also had tenderness in right si joint.(b)(6) 2012 the patient continued with low back pain.(b)(6) 2012 the patient complained of weakness in both legs, pain in hip running under abdomen.3 weeks ago, pain started in groins.She had tenderness in groins.(b)(6) 2012 the patient underwent nm bone imaging whole body due to spinal stenosis.The patient presented with low back pain and has a history of rotator cuff repair in both shoulders.Patient has had multiple low back surgeries and right knee replacement.(b)(6) 2012 patient presented for follow up on bone scan.She had pain and tenderness at si joints, mainly right.(b)(6) 2012 patient presented with right sided lumbar pain, and left sided lumbar pain.(b)(6) 2013 the patient presented for an office visit and stated that she still continued with low back pain.She cannot tolerate ibuprofen, because of upset stomach.Acetaminophen and ibuprofen gave her diarrhea since she had stomach surgery for a hernia.(b)(6) 2014 patient presented with posterior lumbar pain.(b)(6) 2015 the patient presented for an office visit due to lumbar spine intake.Assessment: stenosis, lumbar spine, no neuro claudication; spondylolisthesis, acquired (b)(6) 2015 the patient presented for a follow up for lumbar spine intake.He continued with pain in hips <(>&<)> right thigh, tenderness paraspinal.Assessment: stenosis, lumbar spine, no neuro claudication; spondylolisthesis, acquired.
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Manufacturer Narrative
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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) 2015: patient underwent ct lumbar spine with contrast.On (b)(6) 2015: impression: essentially stable exam with stable retrolisthesis of l5 with respect to l4 and s1.Stable multilevel dege nerative disc disease predominantly involving the l2/3 level predominantly.
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