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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Cyst(s) (1800); Dyspnea (1816); Edema (1820); Fatigue (1849); Headache (1880); Incontinence (1928); Muscle Spasm(s) (1966); Nausea (1970); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Seroma (2069); Swelling (2091); Thyroid Problems (2102); Weakness (2145); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Ulcer (2274); Depression (2361); Pharyngitis (2367); Numbness (2415); Palpitations (2467); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Dysuria (2684)
Event Type  Injury  
Event Description
It was reported that the patient underwent a posterolateral fusion and a posterior lumbar interbody fusion from l4 to s1, during which rhbmp-2/acs was used.Sometime postop, the patient reportedly began to experience nerve injury, radiating pain, and ectopic bone growth that compressed the exiting nerve roots causing pain, numbness, and tingling that radiates into the lower extremities.
 
Manufacturer Narrative
(b)(6).(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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2009: spine degenerative changes are seen.No spinal canal stenosis.Mild neuroforaminal narrowing seen at l3-4.3.Enhancing tissue surrounds the thecal sac at the l4-5 level, as well as seen at the right aspect of the spinal canal at l5-s1.Epidural fibro sis/scarring were possible.Abnormal signal within posterior paraspinal muscles extending caudally from the surgical region may represent persistent postoperative change- versus neuropathy.4.Incidental note made of apparent asymmetric dilatation of the right ren al collecting system, clinical correlation for evidence of right urinary tract obstruction was needed.(b)(6) 2010: patient underwent x-ray of the hip region.Impression: there appear to be minimal degenerative changes in the hips.No fracture.There were postoperative changes from laminectomy and fusion in the lower lumbar spine.(b)(6) 2011: the patient came for an office visit due to lower back and leg pain.Assessment: 1.Radicular lower back pain associated with previous spine surgery.2.Fracture nos-closed.3.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.4.Hemophilia.5.Animal bite-nos.The patient underwent: si joint injection, fluoroscopic guidance for spine injection, low osmolar contrast, methylprednisolone injection.The patient remained hemodynamically stable.(b)(6) 2011, (b)(6) 2012: the patient came for an office visit due to lower back and leg pain.Assessment: 1.Radicular lower back pain associated with previous spine surgery.2.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.3.Hemophilia.
 
Manufacturer Narrative
Additional info: image review 9/26/2006 lumbar series five views of the l4 to s1 construct are provided.Screws are in good position as are rods and crosslink.Interbody spacers are also appropriately positioned within the l4 and l5 disc spaces.Lumbar lordosis is maintained without degenerative changes verified at other levels.(b)(4) 2007 lumbar mri sagittal t2 views show previous lumbar interbody fusion from l4 to s1 with peek spacers, pedicle screws and rods.Decompression has been performed posteriorly with increased signal remaining within the posterior soft tissues.Plif has been performed at l4 and l5 with parallel inter-discal spacers in good position.Insertion tracks of the spacers appear to show some degree of scaring which enhances on the post gadolinium views.There appears to be no recurrent disc herniation or nerve root displacement.Midline decompression has been performed and the thecal sac is not compressed.Pedicle screw position appears satisfactory and within the pedicles and bodies.Fusion cannot be verified on this mri.(b)(4) 2014, abdominal ultrasound no spinal anatomy imaged.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
It was reported that on, (b)(6) 2005: per billing record, the patient underwent mri of lumbar spine.(b)(6) 2007: per billing record, the patient underwent bilateral mammography.(b)(6) 2005: the patient presented for follow up.Ros revealed headache, poor appetite, ulcer nausea, vomiting, stomach pain, constipation, diarrhea, weakness, fatigue weight loss.(b)(6) 2005: the patient presented for medication check.Assessment: patient with low back pain and radicular symptoms with self reported l4-5 herniation and l5-s1 disc narrowing and desiccation with night pain.(b)(6) 2005 the patient was presented for office visit with back pain.Assessments: 1) low back pain, 2) question of a right peroneal neuropathy versus on l5 radiculopathy.(b)(6) 2007: per billing record, the patient underwent mri of lumbar spine.(b)(6) 2005: the patient presented for follow up visit.The patient underwent physical examination.(b)(6) 2005 the patient was presented for office visit with back pain and her leg symptoms.(b)(6) 2005: the patient presented for follow up with complaint of increase low back pain.Physical examination revealed the patient has increased asymmetry of her sacroiliac joint with right sacral rotation.(b)(6) 2008 the patient was presented for office visit with sore throat, calluses on her feet.Assessments:possible yeast infection, superficial laceration, sore throat.(b)(6) 2005: the patient presented with complaint of no coverage especially at night.(b)(6) 2005: the patient underwent caudal epidural injection.(b)(6) 2005: the patient presented for follow up for her caudal epidural injection.Physical examination revealed the patient has pain over the l5-s1 facet bilaterally which radiates into the buttocks bilaterally.(b)(6) 2005: the patient underwent bilateral l5-s1 facet injections.(b)(6) 2005: the patient presented for follow up for her chronic low back pain.(b)(6) 2005: the patient presented for follow up.Assessment patient with chronic low back pain in need of medication change in the evening.(b)(6) 2005: the patient presented for follow up on her ongoing low back pain.Physical examination revealed the patient has pain with flexion.(b)(6) 2005: the patient underwent caudal epidural, l5-s1 procedure.(b)(6) 2008 the patient was presented for office visit with thyroid and depression.Assessments: 1) depression and anxiety 2) hypothyroidism 3) fatigue.(b)(6) 2005: the patient presented for office visit to see her secondary to her pain level.Physical examination revealed patient with chronic low back pain with little response to injections.(b)(6) 2005: the patient presented for follow up for her change in medications.Physical examination revealed patient with chronic low back pain with little response to caudal epidural injections.(b)(6) 2005: the patient presented for assistance with her back pain.Physical examination revealed the patient does have decreased strength on the right over her ehl.(b)(6) 2006: the patient presented for follow-up visit.(b)(6) 2006: the patient presented for follow up for her ongoing low back pain.Physical examination revealed the patient wear an afo on her right leg.(b)(6) 2006: the patient presented for follow-up visit.The patient underwent physical examination.(b)(6) 2006: the patient presented for follow up of her lumbar mri.Physical examination revealed mri of the lumbar spine showed broad based right paracentral disc herniation at l4-5 with central canal stenosis of 9mm.(b)(6) 2006: the patient presented for follow up for her surgical evaluation.Patient found two level degenerative disc disease and stenosis.The patient underwent physical examination.Assessment patient with von willebrand's disease with low back pain and right leg radicular symptoms with two level degenerative disc as well as displacement of the right l5 nerve root.(b)(6) 2006: the patient presented for follow up on chronic back pain and underwent physical examination.(b)(6) 2006: the patient presented for follow up and underwent x-ray of lumbosacral spine, 5 views.Assessment: patient returning for ongoing care and management of low back pain five months status post lumbar fusion.(b)(6) 2006: the patient presented for follow visit and underwent physical examination.(b)(6) 2007: the patient presented for follow with chronic low back pain.The patient underwent physical examination.(b)(6) 2007: the patient presented for follow-up for tapering instructions.Physical examination revealed: the patient has pain with both flexion and extension, but no radiating symptoms at this time.(b)(6) 2007: the patient presented with chronic back pain fro follow-up visit.The patient underwent mri of the lumbar spine with and without contrast.Assessment: unremarkable for evidence of any new disc prostrusion or canal encroachment.The patient is status post three level fusion with hardware in place.(b)(6) 2007: the patient presented for office visit.The patient underwent physical examination.(b)(6) 2006: the patient presented for follow-up having had low back surgery.Physical examination revealed ongoing care and management of low back pain.(b)(6) 2006: the patient presented for follow-up visit.Physical examination revealed patient has an initial, mildly antalgic gait pattern, which smooths after three to four steps.(b)(6) 2006: the patient presented for follow up visit and underwent physical examination.((b)(6) 2008 the patient was presented for office visit with fatigue and migraines.Assessments: 1) migraines 2) fatigue 3) chronic back pain.(b)(6) 2009 the patient presented with pain in the left knee and buttock.(b)(6) 2009 the patient presented with pain in left knee and lower back.(b)(6) 2009 the patient presented with pain in left lower extremity with new bowel constipation.(b)(6) 2009 the patient presented with pain in both legs.The patient also has thoracic muscle spasms.(b)(6) 2009 the patient presented with pain in both legs.The patient also has new medical problems.(b)(6) 2009 the patient presented with pain in hips and in both legs.(b)(6) 2009 the patient presented with pain in left knee and muscle spasms.(b)(6) 2009 the patient presented with pain in lower extremity.(b)(6) 2010: the patient was also presented for office visit with kidney problems.Assessments: 1) possible kidney lesions.2) ongoing nausea.(b)(6) 2010: per billing record, 2.Small cysts seen in both kidneys.3.Benign cyst is seen in the medial inferior aspect of the right liver.Second lesion is seen most posterior and superiorly in the right lobe, seen on additional but not on delay images is of uncertain etiology.This could be a small hemangioma although it does not have all the criteria for hemang ma.If clinically indicated, follow-up ct is suggested for further evaluation.4.Otherwise normal study.Patient underwent ct of abdomen.(b)(6) 2010 the patient presented with leg pain, numbness and weakness.The patient also has a possible block in left kidney.(b)(6) 2010 the patient presented with pain in lower extremity and numbness in the right leg.(b)(6) 2010 the patient was presented for office visit with constipation and nausea.Assessments: menopausal symptoms.2) constipation.(b)(6) 2011 the patient was presented for office visit with thyroid and migraines.Assessments: hypothyroidism, low vitamin b-12, fatigue, anxiety, due for colonoscopy.(b)(6) 2012: assessments: depression, anxiety, hypothyroidism, von willebrand disease, peptic ulcer disease on celebrax, chronic back pain, low b-12.(b)(6) 2014 the patient was presented for office visit with preventative.(b)(6) 2014 the patient was presented for office visit with anxiety labs, cluster headaches, insomnia and preventative.
 
Event Description
On (b)(6) 2008: patient fell injuring her finger.Films were obtained which confirmed fracture.On (b)(6) 2014: patient presented for evaluation of her right hand pain.She described the pain as specifically located in the index finger region of her hand.She was also experiencing numbness, swelling and pain.Patient underwent x-ray of finger (3v) and distal phalanx fracture.Impression: right open wound finger (b)(6) 2014: patient underwent nail bed repair of her index finger with open reduction and internal fixation of distal phalanx fracture.On (b)(6) 2014: patient presented for an office visit post nail bed repair of her index finger.She expressed moderate pain post operatively.There was also minimal swelling of the operative site.Patient underwent x-ray of finger (3v), which revealed satisfactory alignment of the fracture of the index finger.On (b)(6) 2014 patient presented for an office visit post nail bed repair of her index finger.She expressed minimal pain post operatively.Patient underwent x-ray of finger (3v).Impression: congential factor xi deficiency; right open wound finger (b)(6) 2014, per billing records, patient underwent surgery.Diagnosis: calculus of gallbladder without mention of cholecystitis or obstruction; faltulence, eructation and gas pain.On (b)(6) 2014, per billing records, patient presented for office visit.
 
Event Description
It was reported that on, (b)(6) 2007: per billing record, the patient underwent mri of lumbar spine.Impression: unremarkable mr scan of lumbar spine for evidence of disc protrusion or canal encroachment.The patient has undergone a 3 level fusion with hardware in place in the lower lumbar spine.On (b)(6) 2007: review of neuro system: paresthesias-yes in the leg and feet.Review of musculoskeletal system: back pain-yes, muscle weakness yes.Review of psychiatric system: depression - yes, sleep disturbance- yes, anxiety - yes.On (b)(6) 2008 the patient presented for bilateral digital screening mammogram with cad.Impression: negative.There is no mammographic evidence of malignancy.On (b)(6) 2009, patient underwent mri of lumbar spine with and without contrast.Impression: there is persistence of interbody cages at levels l4-5 and l5-s1; however, pedicle screws and connecting rods between l4 and s1 appear to have been removed.Small fluid collections are noted adjacent to the facet joints at l4-5 and l5-s1.Spine degenerative changes are seen as detailed above.No spinal canal stenosis identified.Mild neuroforaminal narrowing seen at l3-4.Enhancing tissue surrounds the thecal sac at the l4-5 level, as well as seen at the right aspect of the spinal canal at l5-s1.Epidural fibrosis/scarring is possible.Abnormal signal within posterior paraspinal muscles extending caudally from the surgical region may represent persistent postoperative change versus neuropathy.Incidental note made of apparent asymmetric dilatation of the right renal collecting system.Clinical correlation for evidence of right urinary tract obstruction is needed.Please see additional findings and details above.On (b)(6) 2009 the patient underwent a bilateral digital screening mammogram with augmentation with cad.Impression: benign.There is no mammographic evidence of malignancy.On (b)(6) 2010: patient underwent ct of abdomen with and without contrast.Impression: bilateral hydronephrosis, right greater than left, both ending at the upj suggesting possible upj obstructing congenital lesions.If clinically indicated, lasix channel renography is suggested for further evaluation.Small cysts seen in both kidneys.Benign cyst is seen in the medial inferior aspect of the right liver.Second lesion is seen most posterior and superiorly in the right lobe, seen on additional but not on delayed images is of uncertain etiology.This could be a small hemangioma although it does not have all the criteria for hemangioma if clinically indicated, follow-up ct is suggested for further evaluation.Otherwise normal study.On (b)(6) 2010 the patient presented with bilateral hydronephrosis.The patient underwent renal scintigram.Impression: good function and excretion in both kidneys.There is no evidence for hydronephrosis in either kidney.On (b)(6) 2011: the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.On (b)(6) 2011 the patient underwent digital diagnostic mammogram with augmentation with cad.Impression: additional evaluation and ultrasound were recommended.There is no abnormality seen in the left breast to correspond with pain.The patient also underwent the ultrasound of the right breast.Impression: benign.There is no sonographic evidence of malignancy.There is no abnormality seen in the right breast to correspond with pain.On (b)(6) 2012 patient presented for office visit with chief complaint of epidural transforaminal.On (b)(6) 2013 patient presented for office visit with chief complaint of epidural transforminal.On (b)(6) 2013, patient presented for office visit with complaint of low back pain and leg pain.She also states that the pain has been worse recently.Assessment: radicular lower back pain associated with previous spine surgery.Hemophilia.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Review of neuro system: paresthesias-yes in the leg and feet.Review of musculoskeletal system: back pain-yes, muscle weakness yes.Review of psychiatric system: depression - yes, sleep disturbance- yes, anxiety - yes.On (b)(6) 2013, patient presented for office visit for chief complaint of strong heartbeat for 1 week.On (b)(6) 2014, patient presented for office visit with complaint of low back pain and leg pain.She also states that the pain has been worse recently.Assessment: radicular lower back pain associated with previous spine surgery.Hemophilia.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Review of neuro system: paresthesias-yes in the leg and feet.Review of musculoskeletal system: back pain-yes, muscle weakness yes.Review of psychiatric system: depression - yes, sleep disturbance- yes, anxiety - yes.On (b)(6) 2014, patient underwent ultrasound of abdomen.Impression: poor delineation of the tail of the pancreas likely due to obscuration by adjacent bowel.Cholelithiasis without evidence of cholecystitis.Stable splenic calcification.Otherwise, unremarkable abdominal ultrasound as described.If there remains additional concern, further evaluation with ct imaging of the abdomen is suggested.On (b)(6) 2014, patient underwent colonoscopy, esophagogastroduodenoscopy for dyspepsia screening.No complications were reported.Impression: hiatal hernia, mild gastritis, clo test, and celiac biopsies pending.On (b)(6) 2014 patient presented for office visit with complaint of low back pain.On (b)(6) 2015 patient underwent ct scan.Impression: heterotopic ossification bone morphogenetic protein out of l4-5 and l5-s1 disk le vels and over the left l3-4 facet joint.On (b)(6) 2015 patient presented for office visit with complaint of low back pain.It was increased with driving and sitting as well as changing position.On (b)(6) 2015 patient presented for office visit with complaint of lower back pain and bilateral hip and legs/ankle/feet pain.On (b)(6) 2015 patient presented for office visit with complaint of low back pain.Review of musculoskeletal system: admits joint stiffness, admits painful joints, admits sciatica.
 
Manufacturer Narrative
Add'l info: (b)(4).
 
Event Description
It was reported that (b)(6) 2006 patient underwent fusion at l4-5 and s1.Patient presented with lumbar degenerative disk disease.Patient underwent laminectomy, discectomy and fusion l4-5, l5, s1.Impression: two level degenerative disc disease and stenosis.Patient presented with degenerative disease ,foraminal stenosis, l4-l5, l5-s1.Procedure: bilateral postrolateral fusion, l4-5, l5-s1.Placement of bilateral pedicle screws, l4-5 and l5-s1, using titanium pedicle system.Bilateral posterior lumbar interbody fusion using peek cages at l4-5, l5-s1.L5 and l4 partial laminectomy.Bilateral l4-5 and l5-s1 lateral recess foraminal decompression and discectomy harvesting of local bone graft.Repair of dural tear.Use of neurovision nerve monitor.Placement of bilateral pumps.Per op notes: peek cages were filled with rh-bmp2/acs impregnated collagen sponge and impacted it in place.The patient underwent mri scan of lumbosacral region.Impression: two-level degenerative disc disease and stenosis.(b)(6) 2006 the patient underwent x-ray of lumbosacral spine 4 views status post lumbar fusion.Impression: the patient is post in terpedicular screws bilaterally with side bars and disc grafts from l4 though s1.Degenerative disc disease is noted at these levels.Mild neuroforaminal narrowing seen at l3-4.Enhancing tissue surrounds the thecal sac at the l4-5 level, as well as seen at the right aspect of the spinal canal at l5-s1.Epidural fibrosis/scarring is possible.Abnormal signal within posterior paraspinal muscles extending caudally from the surgical region may represent persistent post-op changes versus neuropathy.Incidental note made of apparent asymmetric dilatation of the right renal collecting system.Clinical correlation for evidence of right urinary tract obstruction is needed.(b)(6) 2007: patient presented for follow-up.Patient presented with back and leg pain.(b)(6) 2007 the patient presented with lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.(b)(6) 2007: patient presented with low back pain and leg pain.She underwent removal of hardware from l4-5 and l5-s1.Impression: retained fusion hardware.(b)(6) 2007 the patient presented with lower back and leg pain 2 weeks status post hardware removal.She had got a respiratory infection while in the hospital, which she is almost over.Assessment: radicular lower back pain associated with previous spine surgery.(b)(6) 2007 the patient reported telephonically about pain post surgery.(b)(6) 2007 the patient reported that she is suffering from extreme back and left leg pain.(b)(6) 2007 the patient reported that she is having trouble with her surgical site.(b)(6) 2007, (b)(6) 2008 the patient presented with her lower back and leg pain s/p hardware removal.Assessment: radicular lower back pain associated with previous spine surgery.(b)(6) 2008 the patient reported telephonically stating that she cannot urinate due to medication.(b)(6) 2008 the patient reported telephonically of nausea.(b)(6) 2008 the patient reported telephonically stating that she cannot urinate due to medication.(b)(6) 2008 the patient presented for medical follow-up.(b)(6) 2008: patient underwent ct of the right wrist.Impression: intraarticular fracture of the distal radius, involving the dorsal lip.Both horizontal and sagittally oriented fractures along the long axis of the radius are noted.The sagitially oriented fractures along the long axis fracture is distracted by upto 6 mm.There is upto 4 mm of depression along the dorosal lip of fracture.Fracture lines do extend into the druj.Diffuse soft tissue swelling.(b)(6) 2008, the patient came for an office visit due to back and leg pain.Status post fall with right radius fracture.History of hemophilia, factor xi.Cat bite.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.(b)(6) 2008, (b)(6) 2009, the patient presented with pain in her left leg.(b)(6) 2009, (b)(6) 2010, the patient came for an office visit due to 1.Lower back and leg pain.Status post fall with right radius fracture.History of hemophilia, factor xi.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.(b)(6) 2009 the patient presented with pain in the left knee and buttock.(b)(6) 2009 the patient presented with pain in left knee and lower back.(b)(6) 2009 the patient presented with pain in left lower extremity with new bowel constipation.(b)(6) 2009 the patient presented with pain in both legs.The patient also has thoracic muscle spasms.(b)(6) 2009 the patient presented with pain in both legs.The patient also has new medical problems.(b)(6) 2009: patient presented for the follow-up.Impression: left , now bilateral leg pain.Status post lumbar spine surgeries.(b)(6) 2009 the patient presented with pain in hips and in both legs.(b)(6) 2009 the patient presented with pain in left knee and muscle spasms.(b)(6) 2009 the patient underwent mri of lumbar spine w <(>&<)> w/o contrast.Impression: there is a persistency of inter-body cages at levels l4-l5 and l5-s1, however the pedicle screws and connecting rod between l4 and s1 appears to be removed.Small fluid collections are noted adjacent to the facet joints at l4-5 and l5-s1.(b)(6) 2009 the patient presented with pain in lower extremity.(b)(6) 2010 the patient came for an office visit due to lower back and leg pain.History of hemophilia, factor xi.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.(b)(6) 2010: patient underwent x-ray of the hip region.Impression: there appear to be minimal degenerative changes in the hips.No fracture.The lamina and spinous process of l5 have been removed.Bone graft material extends from the transverse processes of l4 down to s1.There appear to be disc prostheses at l4-5 an l5-s1.(b)(6) 2010, (b)(6) 2011, the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.(b)(6) 2011: patient presented for follow-up.(b)(6) 2010 the patient presented with leg pain, numbness and weakness.The patient also has a possible block in left kidney.(b)(6) 2010 the patient presented with pain in lower extremity and numbness in the right leg.(b)(6) 2010 the patient came for an office visit for lumbar facet.(b)(6) 2010 the patient presented with complaints of nausea.(b)(6) 2011: patient presented for follow up.Patient presented with pain in leg, hip.(b)(6) 2010 the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.The patient underwent: si joint injection, fluoroscopic guidance for spine injection, low osmolar contrast, methylprednisolone injection.The patient remained hemodynamically stable.(b)(6) 2011: patient presented for follow up.Patient presented with pain in feet.(b)(6) 2011 the patient presented with complaints of pain in her lower back and buttocks with radiation down the backs of both legs to the bottom of her feet on both sides.Assessment: radicular lower back pain associated with previous spine surgery.Fracture nos-closed.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Animal bite-nos.The patient underwent: si joint injection, fluoroscopic guidance for spine injection, low osmolar contrast, methylprednisolone acetate injection.The patient remained hemodynamically stable throughout the procedure.(b)(6) 2011, the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2011 the came for an office visit for caudal epidural.(b)(6) 2011 the patient presented with pain in her lower extremity.(b)(6) 2011 the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.The patient underwent: l/s transforaminal, l/s tf addl.Levels, fluoroscopic guidance for spine injection, methylprednisolone acetate injection, low osmolar contrast.The patient remained hemodynamically stable throughout the procedure.(b)(6) 2011 the patient came for and office visit for toradol shots due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.The patient underwent ketorolac tromethamine injection.(b)(6) 2011, (b)(6) 2012 the patient came for a follow-up of her chronic pain.The patient complains of continued pain in her sacrum and legs.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2011 the patient presented with chronic low back pain and focal pain s/p hardware removal.(b)(6) 2012 the patient came for a follow-up of her chronic pain.She complains of worsening pain in her lower back and sacral region.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2012, (b)(6) 2013, <(>&<)> (b)(6) 2014, (b)(6) 2010 : patient presented for follow up.Patient presented with pain in hip.(b)(6) 2012, (b)(6) 2015, (b)(6) 2012 the patient came for a follow-up of her chronic pain.She complains of pain continuing in her sacrum, buttocks and legs.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2012, (b)(6) 2013, (b)(6) 2014 the patient presented with complaints of pain in her lower back and buttocks with radiation down the backs of both legs to the bottom of her feet on both sides.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.The patient underwent: l/s transforaminal, l/s tf addl.Levels, fluoroscopic guidance for spine injection, methylprednisolone acetate injection, low osmolar contrast.The patient remained hemodynamically stable throughout the procedure.(b)(6) 2012: patient presented with pain in the feet.(b)(6) 2012, (b)(6) 2013 the patient came for a follow-up of her chronic pain.She complains of pain in her back and legs.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2012: patient presented with back pain.(b)(6) 2013: patient presented with pain in the feet.Patient had mild moderate external bleeding on the left injection site.(b)(6) 2013 the patient came for a follow-up of her chronic pain.She complains of pain in her back and legs and nausea and anxiety due to withdrawal from medications.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.(b)(6) 2013, (b)(6) 2014 the patient came for a follow-up of her chronic pain.She complains of pain in her back and legs.Assessment: radicular lower back pain associated with previous spine surgery.Chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis.Hemophilia.Long-term use med nec.(b)(6) 2014: patient presented for follow up.Patient presented with pain.(b)(6) 2014 the patient underwent us abdominal complete.Impression: poor delineation of the tail of the pancreas likely due to obscuration by adjacent bowel.Cholelithiasis without evidence of cholecystitis.Stable splenic calcification.On an unknown date in (b)(6) 2014, the patient underwent finger reattachment.Since the rh-bmp2/acs surgery, the patient has been suffering from: extreme pain, pain is more severe and occurs more often than before rh-bmp2/acs surgery, nerve injury, radiating leg pain, implant site seroma, additional surgery to help/correct with problems caused by rh-bmp2/acs, mental anguish/depression, bladder incontinence, foot drop, bone growth, and gastrointestinal problems.The symptoms also includes: chronic pain in back and legs, burning and stabbing pain at the site of the rh-bmp2/acs, right foot has dropped making it very difficult to walk, increase in anxiety and depression, bladder incontinence, gastrointestinal problems, limited physical activity and inability to work.The patient also has difficulty running and lifting.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 1998: patient presented for history and physical.Diagnosis: increasing dysmenorrhea, dysfunctional uterine bleeding, disabling dyspareunia.Patient presented with chief complaint of chronic pelvic pain/abnormal uterine bleeding and history of ca uterine.Principal diagnosis: endometriosis of uterus.Patient presented with pre-operative diagnosis of chronic pelvic pain, hypermenorrhea, disabling dysmenorrhea and underwent total abdominal hysterectomy and removal of both ovaries and tubes (bilateral salpingooophorectomy).On (b)(6) 1998: patient's uterus, bilateral tubes/ovaries were submitted for pathology test due to clinical diagnosis of dysmenorrhea, dyspareunia.Microscopic description: the cervix is lined with squamous and columnar mucosa with no viral cytopathic nor dysplastic changes identified.The stroma exhibits no significant inflammation.The endometrium is inactive without evidence of hyperplasia or dysplasia.The myometrium exhibits adenomyosis.The left and right fallopian tubes exhibit full cross sections with lumens identified and without significant inflammation or involvement with tumour.The left and right ovaries reveal hemorrhagic corpora luteum on the left and physiologic cysts with no evidence of tumor.On (b)(6) 1998: patient was discharged.On (b)(6) 2001: patient presented for evaluation of hormones due to hypothyroidism.On (b)(6) 2001: patient presented for follow-up on menopausal symptoms and hypothyroidism.On (b)(6) 2001: patient presented for office visit with complaint of low back pain since altercation with spouse.On (b)(6) 2001:, patient presented for evaluation on von willebrand's disease.Assessment: von willebrand's disease by history and laboratory studies, most likely type 1.Sciatica secondary to probable herniated nucleus pulposus.Left knee arthropathy, possibly secondary to loose cartilage in the joint.Elevated serum iron and % iron saturation found on recent lab studies, etiology undetermined.Hypothyroidism on replacement therapy with synthroid.Postmenopausal surgically on estrogen replacement therapy.On (b)(6) 2001: patient presented for office visit.Patient reported worsening pain and intensified tingling in legs.Ct scan from (b)(6) 2001 showed thin band of soft tissue posterior to l4, l5 vertebral bodies, with questionable minor disc bulge.No significant canal stenosis.Neural foramina were patent.L5-s1 loss of intravertebral disc height and vacuum disc phenomenon, questionable minor posterior disc bulge, but neural foramina patent.On (b)(6) 2001: patient presented for follow-up on von willebrand's disease and sciatica.On (b)(6) 2001: patient presented for office visit due to increasing left knee pain.X-rays showed moderate degenerative changes in medial joint space.Impression: post-traumatic degenerative joint disease.On (b)(6) 2001: patient presented for right knee evaluation and left knee treatment options.Patient underwent x-ray of both knees, which showed minimal joint line narrowing on left knee, and no abnormalities on right knee.Impression: knee pain (b)(6) 2001: patient presented for follow-up on mri which showed no interarticular pathology, and a questionable ganglion cyst around the medial hub of the gastroc.Patient reported burning pain around knee and anterior sharp pain.On (b)(6) 2001: patient presented for follow-up on von willebrand's syndrome.On (b)(6) 2001: patient presented for office visit.Patient reported chronic pain of right knee and back.On (b)(6) 2001: patient presented for office visit for epidural steroid injection.On (b)(6) 2001: patient presented for office visit for pain medications.On (b)(6) 2001: patient presented for office visit.Patient reported insomnia, headaches and history of pancreatic cancer.On (b)(6) 2002: patient presented for epidural steroid injection.On (b)(6) 2002: patient presented for office visit.Patient reported swelling and pain in left knee.On (b)(6) 2002: patient presented for office visit.On (b)(6) 2002: patient presented for office visit due to epigastric pain for two weeks which relieves on eating.Patient reported vomiting at night.On (b)(6) 2002: patient presented for office visit with complaint of chronic insomnia.On (b)(6) 2002: patient underwent upper endoscopy.Indications: the patient is a (b)(6) woman with a several week history of episodic vomiting and epigastric pain.Her pain is relieved with meals.On (b)(6) 2002: patient presented for follow-up.Patient reported abdominal pain.On (b)(6) 2002: patient underwent ct of pelvis with contrast due to questionable pancreatic mass.Impression: small focal hyperdensities seen in the medial aspect of the spleen.Probable calcifications and possibly related to old granulomatous exposure.No obvious pancreatic mass identified.It should be noted that the relative paucity of fat seen within the abdomen makes its distinction from subjacent structures somewhat difficult.No obvious mass is seen nonetheless.No acute intraabdominal findings identified.Right and probable left breast prostheses.On the left, this is not well seen.The uterus is not visualized.Question prior surgical removal.On (b)(6) 2002: patient presented for office visit.Patient reported: right breast rash, low back pain, marital discord.On (b)(6) 2002: patient presented for office visit due to coughing for four days.Patient reported anterior chest pain with cough.On (b)(6) 2002: patient presented for follow-up on upper respiratory tract infection.On (b)(6) 2003: patient presented for office visit.Reason for evaluation: severe shoulder, neck and back pain due to large breast implants, history of von willebrand's disease.On (b)(6) 2003: patient presented for office visit.Diagnosis: shoulder and neck pain due to large implants.History of von willebrand's disease.On (b)(6) 2003: patient admitted with following pre-operative diagnosis: history of previous bilateral augmentation mammoplasty with 600 cc saline implants.On (b)(6) 2003: patient presented for office visit.On (b)(6) 2003: patient presented for office visit.On (b)(6) 2003: patient presented for office visit with complaint of nausea.On (b)(6) 2003: patient presented for evaluation of symptoms of hyponatremia.On (b)(6) 2003: patient presented for office visit.On (b)(6) 2005: patient presented for office visit.Patient reported low back pain and occasional painful defecation.On (b)(6) 2005: patient presented for medication check.On (b)(6) 2005: patient presented for follow-up.On (b)(6) 2005: patient presented for follow-up on sacroiliac and cervical pain.Patient reported increased low back pain.On (b)(6) 2005: patient presented for office visit.Patient reported sacroiliac pain.On (b)(6) 2005: patient presented for office visit due to no coverage especially at night.Patient reported back pain and sacral pain.On (b)(6) 2005: patient presented for follow-up on caudal epidural injections.On (b)(6) 2005: patient underwent procedure for bilateral l5-s1 facet injections due to lumbar facet syndrome.No complications were reported.On (b)(6) 2005: patient presented for follow-up on chronic back pain and response to bilateral l5-s1 facet injections.On (b)(6) 2005: patient presented for follow-up on ongoing low back pain.On (b)(6) 2005: patient presented for follow-up on back pain.On (b)(6) 2005: patient underwent procedure for caudal epidural injections for following indications: low back pain with radicular features.No complications were reported during the procedure.On (b)(6) 2005: patient presented for follow-up on chronic back pain and caudal epidural injections.On (b)(6) 2005: patient presented for office visit due to increased stress and pain.On (b)(6) 2005: patient presented for follow-up on change in medication.On (b)(6) 2005: patient presented for office visit.Patient reported back pain that is radiating into right leg with occasional foot drop.On (b)(6) 2006: patient presented for follow-up for ingoing low back pain and right leg dysfunction.On (b)(6) 2006: patient presented for follow up.Patient presented for electro-diagnostic studies to rule out right l5-s1 radiculopathy.Assessment: patient with tibial motor neuropathy and chronic l5 right radiculopathy.On (b)(6) 2006: patient underwent mri of lumbar spine due to low back pain radiating to both legs and feet.Impression: broad based right paracentral disc herniation at l4-5 with central canal stenosis of 9 mm.There is mass affect and dorsal displacement of the right l5 nerve root are appreciated.Broad based disc bulge and mild facet arthrosis are noted at l5-s1 level.On (b)(6) 2006: patient presented for follow-up on mri of lumbar spine, which showed broad based right paracentral disc herniation at l4-5 with central canal stenosis of 9 mm.There is mass affect and dorsal displacement of the right l5 nerve root.This is worsened from last mri of (b)(6).On (b)(6) 2006: the patient presented to the office for a visit.The patient underwent an mri exam.Impression: two-level degenerative disc disease and stenosis.On (b)(6) 2006: patient presented for pre-operative conference.On (b)(6) 2006: patient presented for follow-up on surgical evaluation.Patient was diagnosed with two level degenerative disc disease and stenosis and doctor decided to proceed with two level posterior lumbar and body fusion from l4 to sacrum.On (b)(6) 2006: patient underwent x-ray of lumbar spine.Impression: satisfactory postsurgical changes on limited lateral view of the lumbar spine.On (b)(6) 2006: the patient presented for an office visit and underwent some radiological tests.Ap lateral lumbar spine films show pedicle screws and interbody cages at l4 to the sacrum to appear to be in good position.On (b)(6) 2006: the patient presented for an office visit.On (b)(6) 2006: the patient presented to the office with complaint of swelling in the legs.The patient underwent some radiological tests.Ap lateral x-rays showed her l4 to s1 fusion with all the hardware to be in good position.On (b)(6) 2007: patient presented for follow-up.Patient presented with back and leg pain.The patient underwent a radiology test.Ap flexion and extension x-rays show a solid fusion from l4 to the sacrum.On (b)(6) 2007: the patient presented for an office visit.On (b)(6) 2007: patient presented with low back pain and leg pain.Impression: retained fusion hardware.The patient underwent removal of fusion hardware.On (b)(6) 2007: the patient presented for a follow up visit after her hardware removal.On (b)(6) 2015: the patient underwent ct scan of the lumbar spine.Impressions: at l5-s1 disc space, there is solid anterior fusion with incorporation of the fusion graft.There is solid posterior osseous fusion.A decompressive laminectomy and medial facetectomy is present.There is no central or s1 lateral recess and dorsal thecal sac is present without meningocele formation.At l3-4 disc space, there is a 2 to 3mm diffuse bulge in the annulus and hypertrophic ligamentum flavum which is calcified.This along with hypertrophic facets creates a dorsi lateral compromise of the thecal sac with moderate right l3 lateral recess stenosis and minimal central canal stenosis.On (b)(6) 2015: patient presented for office visit with tachycardia, fatigue.Reason for referral: dyspnea on exertion and palpations.Review of systems: constitutional: positive for fatigue and weight gain.Musculoskeletal: positive for stiff joints neurological: positive for headaches psych: positive for depression.Assessment: palpations: suspect anxiety, dyspena on exertion and chest pain, vitamin d deficiency, chronic lbp, anxiety.On (b)(6) 2015: patient presented with heart palpations and underwent 7 day cardiac event monitoring ((b)(6)).Findings: the predominant rhythm is sinus rhythm.Interventricular conduction was normal.No atrial fibrillation was detected.There were 13 transmissions including 2 for chest pain and 7 for palpitations and chest fluttering associated with sinus rhythm.One episode was associated with a pac and a 2nd episode was associated with 4 beats of atrial tachycardia.The remaining episodes were associated with sinus rhythm.Conclusion: rare pacs and one 4 beat run of atrial tachycardia.Symptoms were reported by the patient.On (b)(6) 2015: patient underwent treadmill stress echocardiogram.Summary: fair exercise tolerance.Blood pressure response to stress was hypertensive.Bp remained elevated in recovery; 155/84 upon discharge.Stress test was adequate for inducing target heart rate and/or exercise response.Heart rate response to stress was normal.Patient's symptoms were not suggestive of ischemia.Ecg findings are equivocal for ischemia.Echocardiogram is not suggestive of ischemia.On (b)(6) 2015: patient presented for medication refill.Assessment: chronic lbp.On (b)(6) 2015: patient presented for preoperative examination.Patient was scheduled for revision of breast augmentation.Hemophilia was followed by hematology.On (b)(6) 2015: patient presented for a follow-up visit.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that on, (b)(6) 2005: per billing record, the patient underwent mri of lumbar spine due to low back pain, right foot drop, bilateral hip and leg pain.Impressions: mr scan of the l-spine demonstrates degenerative changes of the posterior elements without the presence of disc protrusion or significant canal encroachment.On (b)(6) 2009 the patient presented with complaint of bladder incontinence.On (b)(6) 2011: patient presented for follow-up with leg pain.On (b)(6) 2011: the patient presented with complaints of pain in her lower back and buttocks with radiation down the backs of both legs to the bottom of her feet on both sides.Assessment: radicular lower back pain associated with previous spine surgery; fracture nos-closed; chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis; hemophilia; animal bite-nos.The patient underwent: si joint injection, fluoroscopic guidance for spine injection, low osmolar contrast, methylprednisolone acetate injection.The patient remained hemodynamically stable throughout the procedure.On (b)(6) 2011: the patient came for an office visit due to lower back and leg pain.Assessment: radicular lower back pain associated with previous spine surgery; chronic pain syndrome- associated with post lumbar laminectomy syndrome, radiculitis; hemophilia.On (b)(6) 2013 the patient presented with hip pain.Also the patient had sleep disturbances.On (b)(6) 2014: patient presented for follow up.Patient presented with lower back and hip pain.On (b)(6) 2014 patient consulted surgeon for gallbladder removal.On (b)(6) 2014 patient underwent injections in transforaminal joints went well-hurt more than usual but felt nerves all the way into bottom of feet.On (b)(6) 2014 patient had spinal cord injury.Off all pain rx.On (b)(6) 2014 patient had kidney problems from cleanse.On an unknown date patient had nerve pain in her low back and down the right leg foot was so out of control.On (b)(6) 2014: patient presented with the following assessments: radicular lower pain associated with previous spine-surgery; chronic pain syndrome; fracture nos-closed.On (b)(6) 2014: the patient presented with chronic back pain.Assessment: radicular lower pain associated with previous spine-surgery; chronic pain syndrome; fracture nos-closed.On (b)(6) 2015, patient presented for follow-up on hemophilia c.On (b)(6) 2015, patient underwent following procedure: open capsulectomies, replacement of saline implants with silicone hp implants; due to pre-op diagnosis of: right ruptured saline implant and intact left implant.On (b)(6) 2015 patient presented with lower back and bilateral hip pain and legs/ankle/feet.Pain is exacerbated by movement.On (b)(6) 2016 patient presented for office visit for pain from the waist down.On (b)(6) 2016, (b)(6) 2015 patient presented for office visit for pain located right leg and lower back.On (b)(6) 2016, (b)(6) 2015 patient presented for office visit for lumbar radicular pain.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that on : (b)(6) 2006: the patient presented with swelling in legs.Assessment: dependent edema, skin lesion.On (b)(6) 2007: the patient underwent bilateral mammography.Impression: there is no abnormality seen in the left breast to correspond with reported pain.On (b)(6) 2007: the patient presented for follow up on hypothyroidism.Assessment: hypothyroidism, peripheral neuropathy.On (b)(6) 2007: the patient presented with her lower back and leg pain s/p hardware removal.Assessment: radicular lower back pain associated with previous spine surgery.On (b)(6) 2007: the patient presented with exudative tonsillitis, upset stomach.Assessment: pharyngitis.On (b)(6) 2009: the patient presented for follow up.Assessment: hypothyroidism, chronic back pain and depression.On (b)(6) 2010: the patient presented for follow up visit due to ¿uti¿.Assessment: no evidence of uti and renal dysfunction.On (b)(6) 2014 patient presented due to smash injury.Impression: comminuted second distal phalanx fracture.On (b)(6) 2016: the patient presented for follow up visit.Impression: right leg atrophy.The right leg thigh and calf are slightly smaller and even though slightly decreased than left side; continued similar pain pattern and neurologic weakness with increase in severity.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that on (b)(6) 2015: patient visited office with complaints of chronic low back pain, hypothyroidism and hemophilia c.Patient also complained of getting bad migraines.Patient underwent hematology and other laboratory tests.On (b)(6) 2015: patient presented with an office visit due to dyspnea on exertion and palpitation.On (b)(6) 2015: patient presented for a ct scan of lumbosacral l4-s1.Impressions: evidence of heterotrophic ossification out of the disk space on the right l4-5 that is going into the foramen and next if the thecal sac and on the left side at l5-s1 which appears to be displacing the s1 nerve root slightly posterior.The heterotrophic ossification is also extended superiorly to the l4-5 level and is over the l3-4 facet joint on the left side, where there does appear to be evidence of degenerative changes, with some fragmentation as well as some ankyloses of the joint.On (b)(6) 2015: patient presented for an office visit and was diagnosed with chronic back pain, depression, factor ci deficiency, hypot hyroidism, hemophilia, insomnia, leakage of breast implants and low back pain.On (b)(6) 2015: patient presented for a follow-up visit.Patient underwent a physical examination.Impressions: heterotrophic ossification, bone morphogenic protein out of l4-5 and l5-s1 disk levels and over the left l3-4 facet joint.On (b)(6) 2015: patient presented with following diagnosis: hypothyroidism; insomnia; low back pain; palpitations; breast reconstruction; vaginal candidiasis.On (b)(6) 2015: patient called on phone for early medication refills.On (b)(6) 2015: patient presented with chief complaint of bilateral leg weakness, bilateral back pain, bilateral leg pain, bilateral foot pain.On (b)(6) 2015: patient was presented with follow-up visit for med-refills and following diagnosis: hemophilia c; hsv infection; hypothyroidism; low back pain; mild stress incontinence.On (b)(6) 2015: patient was presented for medication refills and for following diagnosis: constipation; depression; hypothyroidism; low back pain.On (b)(6) 2016: patient presented with follow-up visit for following: lumbar radiculopathy (emg); facet arthropathy; sacroiliac joint dysfunction.
 
Manufacturer Narrative
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.
 
Event Description
It was reported that on, (b)(6) 2016: the patient underwent mri of lumbar spine without contrast due to low back pain and lumbar radiculopathy.Impression: disc disease and facet arthropathy results in mild to moderate neural foraminal narrowing from l1-l2 to l3-l4.No associated spinal canal stenosis or nerve impingement.Status post interbody fusion at l4-l5 and l5-s1.No spinal canal stenosis or neural foraminal narrowing at these disc levels.
 
Event Description
It was reported that on, (b)(6) 2015, the patient underwent ct scan of the lumbar spine.Impression: heterotopic ossification, bone morphogenetic protein out of l4-5 and l5-s1 disk levels and over the left l3-4 facet joint.On (b)(6) 2015, patient presented for office visit with complaint of low back pain.Review of systems: thirteen systems reviewed, notable for easy bruising and bleeding, migraine, glasses, joint pain, depression, sleep disturbance, palpitations, fatigue, bleeding tendency, and bruising.Physical examination: lumbar spine: there was a well-healed midline lumbar scar.There is some tenderness at the upper portion of the scar.No si joint tenderness.Forward flexion is to 50 degrees, bringing the hands within 6 inches of the floor.There is extension to 10 degrees, which causes a pain in her legs.On (b)(6) 2016: the patient presented for follow up due to right hip pain.And had the following assessment: lumbar radiculopathy.Facet arthropathy.Sacroiliac joint dysfunction.On (b)(6) 2016: the patient presented for medication refill and follow up of right hip and knee pain.On (b)(6) 2016: the patient presented with right hip and right knee pain.And had the following assessment: lumbar radiculopathy, facet arthropathy and sacroiliac joint dysfunction.On (b)(6) 2016: the patient presented with pain at lower back, right hip and right knee and had the following assessment: lumbar radiculopathy.Facet arthropathy.Sacroiliac joint dysfunction.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3597497
MDR Text Key4093128
Report Number1030489-2014-00270
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510800
Device Lot NumberM115010AAH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/21/2015
Initial Date FDA Received01/29/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received06/19/2015
12/09/2015
12/16/2015
01/11/2016
02/02/2016
03/21/2016
04/18/2016
05/02/2016
05/25/2016
07/14/2016
08/16/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight54
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