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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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| Model Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Extreme Exhaustion (1843); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Swelling (2091); Thyroid Problems (2102); Weakness (2145); Tingling (2171); Chills (2191); Dizziness (2194); Stenosis (2263); Distress (2329); Malaise (2359); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Cognitive Changes (2551)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a transforaminal lumbar interbody fusion ("tlif") l5-s1 using a peek interbody cage filled with rhbmp-2/acs.A plf was performed at the same level.Bmp2 was also placed in the posterolateral gutters spanning the transverse processes.Following her surgery, the patient initially improved, but subsequently developed additional, new and/or worse pain, suffering, symptoms and disability.Specifically, the patient has developed progressive, disabling pain in her lower back, radiating to her legs, numbness in her feet and persistent hip pain.
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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.
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Manufacturer Narrative
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(b)(4).
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Event Description
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In 2003, the patient underwent osteopathic manipulation therapy for several visits and she was diagnosed with si joint pain.It was reported that on (b)(6) 2003 the patient complained of low back pain.On (b)(6) 2003, the patient presented for a follow up on neck and low back pain.On (b)(6) 2005 the patient presented with low back pain and foot (2 toes) (b)(6) 2012 the patient presented with low back pain with radiation into right leg.She described the pain as aching, sharp, piercing and throbbing.On (b)(6) 2013 the patient presented for an independent medical evaluation.She complained of low back pain rated at 7/10, increased with any physical activity.She reported pain, numbness and tingling radiating into both legs, right greater than the left.Diagnoses: chronic low back pain; grade i spondylolisthesis l4 on l5; status post l4-5 fusion.On (b)(6) 2006: patient was discharged home.On (b)(6) 2006: patient presented with pre-op diagnosis: morbid obesity, gastroesophageal reflux disease.Patient underwent esophagogas troduodenoscopy, diagnostic.Pre-op diagnosis of morbid obesity and multiple comorbidities.Patient underwent laparoscopic roux-en-y gastric bypass.No complications reported.Findings: malrotation of her gastrointestinal tract.
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that on (b)(6) 2015 <(>&<)> (b)(6) 2015 , the patient presented for office visit.(b)(6) 2015 , the patient presented for office visit.(b)(6) 2015 , the patient presented for various laboratory evaluation and ct abdomen and pelvis w-o contrast.(b)(6) 2015, the patient presented for ct myelogram of lumbar spine.Impression : postoperative changes at l5-s1 with laminectomy defect.Minimal grade 1 anterolisthesis of l5 on s1 unchanged.(b)(6) 2015 , the patient presented for evaluation of easy bruishing with no significant bleeding.Assessment : vit b1 deficiency.(b)(6) 2015 , the patient presented for office visit.(b)(6) 2015 the patient presented for follow up of her pain.
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Event Description
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It was reported that on, (b)(6) 2015 the patient presented with complaints of bipolar depression and back pain.On (b)(6) 2015 , the patient presented for office visit.The patient complained of severe low back pain with some radiation into the hips and legs.Ct myelogram from (b)(6) 2015 showed: "postoperative changes at l5-s1 with laminectomy defect.Minimal grade 1 anterolisthesis of l5 on s1 unchanged; tiny amount of density noted in the right neuroforamen at l5-s1.His probably reflects a small amount of post surgical granulation / scar tissue." on (b)(6) 2015 the patient was administered right transforaminal epidural steroid injection.Assessment : intervertebral disc disorders with radiculopathy , thoracic region.On (b)(6) 2015 the patient presented for an office visit.On (b)(6) 2016 the patient presented for an office visit with complains of low back pain radiating into the right hip and right leg.On (b)(6) 2016, (b)(6) 2015 the patient presented for follow up of pain.
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Event Description
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(b)(6) 1991: patient underwent pap smear.Diagnosis: within normal limits.(b)(6) 1998: the patient presented with complaints of nausea.(b)(6) 1999: the patient was admitted in a hospital with admit diagnosis of preg state and anemia.(b)(6) 1999, (b)(6) 2000, (b)(6) 2001: patient underwent pap smear.Diagnosis: there are no epithelial abnormalities present.(b)(6) 2002: the patient presented for follow up.(b)(6) 2002: the patient presented for annual examination.Patient underwent pap smear.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2003: the patient presented for an office visit.Patient underwent pap smear.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6)-2004: the patient screened positive for down syndrome.(b)(6) 2004: the patient presented with following diagnosis: wks r/o labor.(b)(6) 2004: patient presented with diagnosis of supervis oth normal preg and threat labor nec-antepar.(b)(6) 2004: patient presented with diagnosis of supervis oth normal preg and essen hypertension.On (b)(6) 2004, the patient presented for annual follow up.(b)(6) 2004: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2005: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6)-2006: the patient presented for annual follow up.Impressions: annual examination and dysfunctional uterine bleeding.(b)(6) 2006: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2007: the patient also presented for annual examination.Impressions: pelvic organ prolapse and dysfunctional uterine bleeding.(b)(6) 2007: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2008: the patient also presented with following pre-op diagnosis: pop/gsui.(b)(6) 2008: the patient leaked with cough, straining and lifting.(b)(6) 2008: patient presented with fem stress incontinence.(b)(6) 1991: patient underwent pap smear.Diagnosis: within normal limits.(b)(6) 1998: the patient presented with complaints of nausea.(b)(6) 1999: the patient was admitted in a hospital with admit diagnosis of preg state and anemia.(b)(6) 1999, (b)(6) 2000, (b)(6) 2001: patient underwent pap smear.Diagnosis: there are no epithelial abnormalities present.(b)(6) 2002: the patient presented for follow up.(b)(6) 2002: the patient presented for annual examination.Patient underwent pap smear.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2003: the patient presented for an office visit.Patient underwent pap smear.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6)-2004: the patient screened positive for down syndrome.(b)(6) 2004: patient presented with abdomen and back pain.The patient presented with following diagnosis: wks r/o labor.(b)(6) 2004: patient presented with diagnosis of supervis oth normal preg and threat labor nec-antepar.(b)(6) 2004: pateint presented with diagnosis of supervis oth normal preg and essen hypertension.On (b)(6) 2004, the patient presented for annual follow up.(b)(6) 2004: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy (b)(6) 2005: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6)-2006: the patient presented for annual follow up.Impressions: annual examination and dysfunctional uterine bleeding.(b)(6) 2006: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2007 the patient also presented for annual examination.Impressions: pelvic organ prolapse and dysfunctional uterine bleeding.(b)(6) 2007: patient underwent thinprep pap with cytyc imaging.Diagnosis: negative for intraepithelial lesion or malignancy.(b)(6) 2008 the patient also presented with following pre-op diagnosis: pop/gsui.(b)(6) 2008 the patient leaked with cough, straining and lifting.(b)(6) 2008: patient presented with fem stress incontinence.(b)(6) 2008 patient underwent mslt study.Impression: obstructive sleep apnea using a cpap machine.Hyper somnolence.(b)(6) 2008 the patient had idiopathic hypersomnia and presented for a follow up.(b)(6) 2009: patient underwent thyroid ultrasound due to hypothyroid and thyroid cyst.Impression: small left thyroid cyst, otherwise unremarkable exam.(b)(6) 2012: patient presented with physical discomfort as noticed in her walk as well as inability to get comfortable when seated.Patient also discussed her sadness.(b)(6) 2012: patient presented being anxious, nervous and stressful.(b)(6) 2012: patient presented with hurting back.(b)(6) 2013: patient presented for follow up and discussed her inability to focus.Patient discussed her anxiety issues.(b)(6) 2013: patient presented for follow up stating that she was emotionally exhausted.Patient said she felt she was doing ok in dealing with her depression.(b)(6) 2013: patient presented reporting that her overall anxiety has decreased but still fluctuated in the proportion to the level of pain she experienced.(b)(6) 2013: patient presented stating that she had a battle going within her mind, thinking too much and causing herself to feel a great deal of insecurity.Per doctor, cognitive distortions were challenged concerning her fears and insecurities.(b)(6) 2015, (b)(6) 2015: patient presented with following diagnoses: major depressive disorder moderate; generalized anxiety disorder; partner relation problem.(b)(6) 2006 the patient presented for evaluation of morbid obesity.The patient also reported anxiety.Assessment: hypothyroidism (stable); morbid obesity (stable); anxiety state unspecified (stable); unspecified sleep apnea (stable); shortness of breath (stable); diabetes mellitus, type 2 (stable); hypertension unspec (stable); esophageal reflux (stable); atrial fibrillation (resolved) (b)(6) 2006 the patient presented for a post op visit.Assessment: hypothyroidism (stable); morbid obesity (stable); anxiety state un specified (stable); unspecified sleep apnea (stable); shortness of breath (stable); diabetes mellitus, type 2 (stable); hypertension unspec (stable); esophageal reflux (stable) (b)(6) 2006 the patient presented with the complaint of constipation.Assessment: hypothyroidism (stable); morbid obesity (stable); anxiety state unspecified (stable); unspecified sleep apnea (stable); shortness of breath (improving); diabetes mellitus, type 2 (resolved); hypertension unspec (resolved); esophageal reflux (resolved) (b)(6) 2006 the patient complained of constipation, increased hot liquids.The patient was taking colace daily.Assessment: dependent edema/lymphedema (stable); hypothyroidism (stable); morbid obesity (diagnosed & treating); anxiety state unspecified (stable); unspecified sleep apnea (improving); shortness of breath (resolved).(b)(6) 2007 the patient presented for post operative follow up and complained of being tired.Assessment: dependent edema/lymphedema (stable); hypothyroidism (stable); morbid obesity (improving); anxiety state unspecified (stable); unspecified sleep apnea (improving).(b)(6) 2007 the patient presented for post operative follow up and labs evaluation.The patient was overall doing well.Assessment: dependent edema/lymphedema (resolved); hypothyroidism (stable); morbid obesity; anxiety state unspecified (improving); unspecified sleep apnea (resolved).(b)(6) 2008 the patient presented for a follow up.Patient reported a new diagnosis of idiopathic hypersomnia.Assessment: hypothyroidism; morbid obesity; anxiety state unspecified.
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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) 2012: the patient presented with complaint of fatigue, lower back and leg pain, anxiety, depression, difficulty relaxing, difficulty concentrating, confusion and poor impulse control.Applicable symptoms includes depression, low energy, low self-esteem, poor concentration, sleep disturbance, anxiety, sweating, chills/ hot flashes, worthlessness, stress.Impression: generalized anxiety disorder; major depressive disorder, recurrent; hypothyroidism; hypertension.On (b)(6) 2014, patient presented for office visit and reported low back pain.Symptoms are aggravated by sitting, standing and walking.On (b)(6) 2015, patient reported low back pain and im injection was administered.On (b)(6) 2015, patient presented for transforaminal epidural steroid injections.On (b)(6) 2015, patient presented for office visit and reported low back pain which radiates to left leg and right thigh and foot.Pain is aggravated by daily activities, bending, lifting, pushing, standing, twisting and walking.On (b)(6) 2015, patient presented for caudal epidural steroid injection.On (b)(6) 2015: the patient presented for various laboratory evaluation and ct abdomen and pelvis w-o contrast.Impression: slight increased stool burden with the cecum and terminal ileum which lies within the left lower quadrant from likely congenital nonrotation of the bowel; no inflammatory changes or abscess formation.Diverticulosis is noted without evidence of acute diverticulitis.On (b)(6) 2015: the patient underwent bone density axial skeleton exam.On (b)(6) 2015: the patient underwent x-ray myelogram lumbosacral due to degeneration of lumbar, thoracic or i/s neuritis.Impression: successful lumbar myelogram (b)(6) 2015, (b)(6) 2016: the patient presented for an office visit with complaint of low back pain, lumbar spinal stenosis post low back and right leg injury.Pt described pain as sharp, dull and aching with weakness and numbness in right thigh.The pain was radiating to the right foot.Assessment: other intervertebral disc degeneration, lumbosacral region; low back pain; post laminectomy syndrome, not elsewhere classified; other spondylosis with radiculopathy, lumbar region; intervertebral disc disorders with radiculopathy, thoracic region; lumbago; osteoarthrosis.On (b)(6) 2015: the patient presented for evaluation of easy bruising with no significant bleeding.Assessment: vit b1 deficiency.On (b)(6) 2015: patient presented to clinic for a workers comp related injury to the lower back.Patient stated the pain radiates to the right leg and as aching, bumping and sharp.Assessment: degeneration of lumbar or lumbosacral intervertebral disc; lumbar post laminectomy syndrome; lumbosacral spondylosis without myelopathy.Osteoarthrosis, unspecified whether generalized or localized, involving unspecific site; radiculitis, thoracic or lumbar.On (b)(6) oct 2015: the patient presented with complaint of workman related injury and for lumbar epidural steroid injection l5-s1 due to back pain.Assessment: degeneration of lumbar or lumbosacral intervertebral disc; lumbar post laminectomy syndrome; radiculitis, thoracic or lumbar.On (b)(6) 2015, patient presented for office visit and reported low back and right leg pain.On (b)(6) 2015: the patient underwent mri of cervical spine without contrast due to degenerative disc disease.Impression: multilevel degenerative disk disease, most pronounced at the c3-c4 through c5-c6 level with disk osteophyte complexes and resultant spinal canal and neuroforaminal stenosis.
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Manufacturer Narrative
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Additional information: pt info.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that on : (b)(6) 2010: patient presented for post surgery follow up with right leg pain.Assessment : healing postoperative relief from her l5-s1 transforaminal lumbar interbody fusion.On (b)(6) 2011: the patient presented for office visit with back discomfort and right anterior thigh and hip pain.Patient under went ct scan which revealed stable hardware.On (b)(6) 2011: the patient presented with increased low back pain after last therapy.On (b)(6) 2011: the patient presented for office visit with a concern of going back to work.04 feb 2011: patient presented for follow up with right anterior thigh pain.Patient under went radiographs of lumbar spine.Impression: good position of hardware and interbody peek cage.A cat scan was done which showed no obvious foraminal encroachment.On (b)(6) 2011: patient presented for follow up with back discomfort and some thigh and hip pain.Patient under went ct scan of lumbar spine.Impression: ct scan reveals stable hardware.There is no pedicle breach of the hardware and her foramen are open.On (b)(6) 2011: patient presented for follow up with right anterior thigh pain.Patient's radiographs were viewed which showed good position of hardware and interbody peek cage.Assessment: right anterior thigh pain.A cat scan was done which showed no foraminal encroachment.On (b)(6) 2011: diagnosis: status post fusion.She was still quite miserable.She had anterior thigh pain.On (b)(6) 2011: patient presented for office visit.On (b)(6) 2011: patient presented with low back pain, bilateral lower extremity radiculopathy, failed back surgery syndrome, lumbar deg enerative disk disease.On (b)(6) 2013: patient presented for follow up with pain in lower back and legs.Assessment: lumbago.Lumbosacral spondylosis without myelopathy.Degeneration of lumbar or lumbosacral intervertebral disc.Radiculitis, thoracic or lumbar.Osteoarthrosis.On (b)(6) 2014, patient presented for office visit and reported low back pain.Symptoms are aggravated by sitting, standing and walking.Assessment: degeneration of lumbar or lumbosacral intervertebral disc.Lumbago.Lumbosacral spondylosis without mye lopathy.Osteoarthrosis.Radiculitis, thoracic or lumbar.On (b)(6) 2015: patient presented for office visit with low back pain and right leg pain.Review of systems: constitutional: chills and fever.Neuro: dizziness, weakness, headache, numbness, gait disturbance.Musculoskeletal: back pain.Assessment: degeneration of lumbar or lumbosacral intervertebral disc.Radiculitis, thoracic or lumbar.Lumbosacral spondylosis with myelopathy.Lumbago.Osteoarthrosis.(b)(6) 2015: patient presented for office visit and reported low back and right leg pain.Assessment: degeneration of lumbar or lumbosacral intervertebral disc.Radiculitis, thoracic or lumbar.Lumbosacral spondylosis with myelopathy.Lumbago.Osteoarthrosis.On (b)(6) 2015, patient reported low back pain and im injection was administered.Assessment: lumbar post laminectomy syndrome.L umbosacral spondylosis without myelopathy.Radiculitis, thoracic or lumbar.Degeneration of lumbar or lumbosacral intervertebral disc.Lumbago.On (b)(6) 2015, patient presented for transforaminal epidural steroid injections l5-s1.Assessment: lumbar post laminectomy syndrome.Lumbosacral spondylosis without myelopathy.On (b)(6) 2015: patient presented for office visit with low back pain.Assessment: lumbar post laminectomy syndrome.Degeneration of lumbar disc.Radiculitis, thoracic or lumbar.Lumbosacral spondylosis with myelopathy.Lumbago.Osteoarthrosis.On (b)(6) 2015: patient presented for office visit.Assessment: lumbar post laminectomy syndrome.On (b)(6) 2015, patient presented for caudal epidural steroid injection.Assessment: lumbar post laminectomy syndrome.Degeneration of lumbar disc.Radiculitis, thoracic or lumbar.Lumbosacral spondylosis with myelopathy.On (b)(6) 2015, patient presented for office visit and reported low back pain which radiates to left leg and right thigh and foot.Pain is aggravated by daily activities, bending, lifting, pushing, standing, twisting and walking.Assessment: lumbar post laminectomy syndrome.Radiculitis, thoracic or lumbar.Degeneration of lumbar disc.Lumbosacral spondylosis with myelopathy.Osteoarthrosis.On (b)(6) 2015 the patient presented with complaints of bipolar depression and back pain.Patient presented for follow up with work compensation related injury.Assessment: degeneration of lumbar disc.Lumbar post laminectomy syndrome.Lumbago.Lumbosacral spondylosis without myelopathy.Osteoarthrosis.Radiculitis, thoracic or lumbar.Patient's ct was reviewed which showed: postoperative changes at l5-s1 with laminectomy defect.Minimal grade 1 anterolisthesis of l5 on s1 unchanged.Tiny amount of density noticed in right neuroforamen at l5-s1.Osteoarthrosis.Radiculitis.On (b)(6) 2015: patient presented for follow up for right transforaminal epidural steroid injection and injury to back.Assessment: in tervertebral disc disorders with radiculopathy, thoracic region.On (b)(6) 2015 the patient presented for an office visit.Patient reported pain in lower back and right leg which increases with standing, sitting or walking.Assessment: intervertebral disc degeneration, lumbosacral region.Low back pain.Post laminectomy syndrome.Other spondylosis with radiculopathy, lumbar region.Intervertebral disc disorders with radiculopathy, thoracic region.On (b)(6) 2015, (b)(6) 2016:the patient presented with pain in left side of neck, shoulder and arm and radiating pain originating from c6 level on left travelling to left anterior s houlder/elbow.Neck pain with a radiating component into left shoulder/arm in c5/c6 dermatomal pattern with numbness and tingling.On (b)(6) 2015 : assessment: intervertebral disc generation.Intervertebral disc disorders with radiculopathy, thoracic region.Post laminectomy syndrome.On (b)(6) 2015, patient presented for office visit due to severe low back pain with some radiation into hips and legs.Assessment: post laminectomy syndrome.On (b)(6) 2016 the patient presented for an office visit with complains of low back pain radiating into the right hip and right leg.Ros: musculoskeletal: back pain.Assessment: post laminectomy syndrome.Patient's ct myelogram shows: postoperative changes at l5-s1 with laminectomy defect.Tiny amount of density noted in right neuroforamen at l5-s1.On (b)(6) 2016: patient presented with an office visit for a follow-up.Assessment: major depressive disorder, recurrent episode, moderate.Patient also underwent a physical examination.Assessment: patient walks without assistance and in no apparent distress.Gait intact.No tremor noted.On (b)(6) 2016: patient presented for follow up with work compensation related injury, pain in right thigh and right leg and lumbar spinal stenosis.Assessment: post laminectomy syndrome.On (b)(6) 2016: patient presented for a follow-up visit.Assessment: major depressive disorder.On (b)(6) 2016: patient presented for workers compensation related injury and lumbar spine stenosis.Assessment: post laminectomy syndrome.
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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) 2013: patient presented for office visit for evaluation of memory and attentional impairment.Review of system is positive for back pain.Assessment: cognitive functions current level impaired.On (b)(6) 2013: patient underwent mri of brain due to mild cognitive impairment.Impression: normal examination.
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