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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 7510600 |
| Device Problem
Patient-Device Incompatibility (2682)
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| Patient Problems
Neuropathy (1983); Thyroid Problems (2102); Weakness (2145); Chronic Obstructive Pulmonary Disease (COPD) (2237); Neck Pain (2433); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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| Event Date 02/12/2014 |
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2009 the patient presented with history of pancreatitis and underwent upper abdominal sonogram.The patient presented with abdominal pain and underwent ct of the abdomen <(>&<)> pelvis.(b)(6) 2009 the patient presented with history of diarrhea and vomiting.The patient underwent x-rays of the chest.The patient underwent ultrasound of the abdomen.Also the patient presented with c/s diverticulitis and underwent ct of the abdomen.The patient underwent ct of the pelvis.On (b)(6) 2010 the patient was status post trauma one month ago.The patient underwent mri of the lumbar spine due to low back pain and bilateral lower extremity spasms.On (b)(6) 2010 the patient underwent mri of the cervical spine due to cervical pain radiating to both shoulders as well as bilateral hand numbness.The patient underwent mri of the thoracic spine due to low back pain radiating to the left buttock.On (b)(6) 2010 the patient presented with c/s diverticulitis and underwent ct of the abdomen <(>&<)> pelvis.On (b)(6) 2010 the patient underwent x-rays of the chest due to shortness of breath.On (b)(6) 2010 the patient underwent x-rays of the chest due to shortness of breath.On (b)(6) 2010 the patient was status post fall and underwent ct of the head.The patient also underwent ct of the maxillofacial bones.The patient also underwent x-rays of the right hand.Impression: intact right hand.The patient also underwent x-rays of the left hand.The patient also underwent x-rays of the left wrist.The patient also underwent x-rays of the right wrist.Surrounding soft tissues fail to demonstrate a radiopaque foreign body.The patient also underwent x-rays of the right knee.The patient also underwent x-rays of the left knee.The patient also underwent x-rays of the cervical spine.The patient also underwent x-rays of the lumbosacral spine.On (b)(6) 2010 the patient underwent x-rays of the chest due to syncope.The patient also underwent bilateral carotid ultrasound examination due to rhadomyloysis c/s stenosis.The patient also underwent ct of the lumbar spine.On (b)(6) 2011 the patient underwent x-rays of the chest due to shortness of breath.On (b)(6) 2011 the patient presented with the pre op diagnosis of r/o polyp.The patient underwent egd biopsy.Diagnosis: proximal transverse colon, biopsy: tubular adenoma.On (b)(6) 2012 the gyn cytology report was negative for intraepithelial lesion or malignancy.On (b)(6) 2012 the patient underwent bilateral screening mammography.On (b)(6) 2012 the patient underwent x-rays of the chest.On (b)(6) 2012 the patient presented for a consultation of chronic neck and back pain.She was also diagnosed with fibromyalgia.The pain in the back is constant, sharp, shooting, burning and aggravated by walking, bending, coughing.It radiates down the legs to the ankles and is associated with tingling numbness.It is associated with weakness in the right leg and it gives out.There is muscle spasm in the back and leg.The pain the neck is sharp, shooting, burning and aggravated by coughing.It radiates down the arms to the fingers on the right and left associated with tingling numbness in the thumb index middle ring and little finger.It is associated with weakness in right and left hand and drops things.There is muscle spasm in the neck shoulder upper back.The lumbosacral spine exhibited normal appearance, tenderness on palpation, and muscle spasms.There was extensive amount of myofascial pain in the lumbar paravertebral, gluteal, piriformis and iliotibial fascia.Tenderness over the l5-s1 facet joints right and left and spine.On (b)(6) 2012 (b)(6) 2013 the patient presented for an office visit.On (b)(6) 2012 the patient presented for a follow up for his chronic back pain and bilateral leg pain.On (b)(6) 2012 the patient presented for a follow up for his chronic body pain resulting from fibromyalgia.On (b)(6) 2012 the patient presented for a follow up for his chronic back pain, bilateral leg and arm pain.Tripped and fell one week ago, pain in the back increased, getting numbness in the right ring and little finger.On (b)(6) 2012 the patient presented with the complaints of pain in upper back and lower back, left arm, left leg and left side.On (b)(6) 2012 the patient presented with the history of stroke, left sided weakness and underwent smr of the brain.On (b)(6) 2012 the patient presented with the history of neck pain with radiculopathy and underwent smr of the cervical spine.On (b)(6) 2012 the patient presented for a follow up for his chronic back pain which is worse because ms contin is not working for her.On (b)(6) 2012 the patient presented for a follow up for his chronic neck pain and migraine.Back hurts in the thoracic area; neck is bad, getting headaches, getting numbness in the both hands ring and little finger.The pain in the low back is intermittent.No (b)(6) 2012 the patient presented for neuro surgical re-evaluation.No (b)(6) 2012 the patient presented for a follow up for his chronic pain in back, bilateral hips and leg.On (b)(6) 2012 the patient presented with the history of lower back and bilateral leg pain, worsening pain with physical therapy.The patient underwent mri of the lumbar spine.On (b)(6) 2012 the patient presented with the complaint of ¿pain all over¿.The patient had a vaginal hernia and being evaluated for hysterectomy.On (b)(6) 2013 the patient presented with the complaint of pain in lower back especially and legs, neck and right side of upper back.No (b)(6) 2013 the patient presented for neuro surgical re-evaluation.She has decreased range of motion of the cervical and lumbar spine.She has diffuse tenderness throughout the cervical, thoracic and lumbar spine.She has a palpable lipoma throughout the cervicothoracic junction.No (b)(6) 2013 the patient presented with the complaint of ¿pain all over¿ and shooting pain down both legs.No (b)(6) 2013 the patient underwent x-rays of the chest for pre op evaluation.No (b)(6) 2013 the patient presented with the pre op diagnosis of cystocele, uterine prolapse, chronic pelvic pain.The patient underwent the following procedure: robotic laparoscopic-assisted total hysterectomy.No patient complications were noted.The pathology tissue report showed an adenomatoid tumor in the myometrium of the uterus.The immunohistochemistry stain results are compatible with those reported for adenomatoid tumors.The tumor appears confined to the myometrium.It measures approximately 5 x 6 mm in cross section dimensions.It is not seen on the serosa.These tumors rarely reoccur.On (b)(6) 2013 the patient had total hysterectomy, bladder lift and hernia repair 2 weeks ago.Low back stomach and leg pain are the worse.On (b)(6) 2013 the patient presented with pain in lower back down legs and into toes.Pain has increased in the back and tingling numbness in the toes has increased.On (b)(6) 2013 the patient underwent ct of the head due to trauma.On an unknown date in (b)(6) 2013, the patient underwent a lumbar spinal fusion for scoliosis.On (b)(6) 2013 the patient presented for ap, lateral standing scoliosis study.On (b)(6) 2013 the patient presented for x-rays of the lumbar spine.Chest x-rays showed interval placement of spinal hardware in the thoracic spine.Right central venous catheter seen with tip in the svc, near the svc/right atrial junction.Lung fields are clear.No pneumothorax is seen.The pathology tissue report showed portions of fibrocartilage with reactive and degenerative changes.Small portions of unremarkable trabecular bone present.On (b)(6) 2013 the patient presented for a scoliosis study to reassess patient¿s extensive changes of spinal fusion.On (b)(6) 2013 the patient presented for a follow up.Assessment: back pain; addison¿s disease; seizure disorder; gerd (gastroesophageal reflux disease); depression with anxiety; anemia; asthma; insomnia.On (b)(6) 2013 the patient presented for a follow up and complained of constipation.Assessment: back pain; addison¿s disease; copd; seizure disorder; gerd (gastroesophageal reflux disease); anemia; abnormal blood chemistry; constipation.On (b)(6) 2013 the patient presented for pre op clearance for repair of cystocele.Chest x-ray is clear and it showed no consolidation or effusion.Ekg reviewed and is normal.Assessment: cystocele; pre op clearance.On (b)(6) 2013 the patient presented with the pre op diagnosis of symptomatic cystocele.The patient underwent anterior repair, colporrh aphy.Diagnosis: mucosa, vaginal, segments: parakeratosis.Mild nonspecific chronic inflammation.Postoperative diagnosis: symptomatic cystocele including 4th degree cystocele, good apical vaginal support, no evidence of rectocele under anesthesia.There were no complications.(b)(6) 2013 the patient presented with the chief complaint of fibromyalgia.Assessment: back pain; nausea.On (b)(6) 2013 the patient presented for a follow up and she noted increased pain.Assessment: back pain.On (b)(6)2013 the patient presented with the chief complaint of addison¿s disease.Assessment: adrenal insufficiency; hypothyroidism; tobacco abuse.On (b)(6) 2013 the patient presented with a history of lumbar spine disk disease and cervical spine disk disease.Apparently 2 days ago, the patient fell hitting her head on the left side.She complained of headache which is mostly left hemicranial.On (b)(6) 2013 the patient underwent ct of the head due to pain from trauma.On (b)(6) 2013 the patient presented for a follow up and meds refill.Assessment: back pain; addison¿s disease; copd 10/03/2013 the patient underwent x-rays of the chest due to chest pain.On (b)(6) 2013 the patient presented for meds refill.Assessment: back pain; addison¿s disease.On (b)(6) 2013 the patient presented for a follow up and meds refill.Assessment: back pain; hypothyroidism; gerd.On (b)(6) 2013 the patient presented for a follow up and meds refill.Assessment: back pain; dry skin; gerd.On (b)(6) 2013 the patient was in a motor vehicle accident on (b)(6) 2013 and the patient had increased lower back pain since.She also had neck pain with radiation into his arms.Assessment: back pain; neck pain; mva.(b)(6) 2014 the patient has increased pain from mva and presented for meds refill.The pain in neck area with radiation into arms from being thrown forward.There were constant pinching feeling, weakness, and limited rom.Assessment: back pain; hypothyroidism; gerd; copd; mva.On (b)(6) 2014 the patient presented for meds refill.She still has increased pain from mva.Assessment: back pain; anemia; hypothyroidism.On (b)(6) 2014 the patient presented with the chief complaint of back pain.The patient felt something crack in her lower back.She had severe pain her lumbar spine.Assessment: low back pain secondary to fractured hardware; urinary retention; copd; depression; addison¿s disease; hypothyroidism; constipation; seizure disorder; smoking cessation.On (b)(6) 2014 the patient presented with the chief complaint of back pain.Assessment: lumbar spinal fusion hardware failure; severe low back pain; addison¿s disease; copd; derpression; hypothyroidism.On (b)(6) 2014 the patient presented with the pre op diagnoses of spinal stenosis, flat back deformity, nonunion.The patient underwent the following procedures: lateral extra cavitary approach to l2-l3; l3-l4 through the left side approach; revision of lumbar instrumentation l2 to l4; l2 to l4 fusion using local bone, one large kit of bone morphogenic protein, and 10 ml of bone graft; d.L.I.F l2-l3, l3-l4 with 10 x 50 mm 6-degree offset peek cages for fusion with bmp and bone graft.Per the op notes, decortication was then performed from l2 to l4.The bone graft, which was basically local bone, bmp, and bone graft was placed.Ap and lateral image showed good position of the spine as well as the instrumentation.No patient complications were noted.On (b)(6) 2014 the patient was discharged from the hospital.On (b)(6) 2014 the patient presented due to mva and was status post discharge from hospital for fractured hardware in back.Assessment: back pain (b)(6) 2014, (b)(6) 2014 the patient presented for follow up and meds refill.She noted more leg pain, neck and back pain.Assessment: back pain; neuropathic pain of lower extremity; anemia; hypothyroidism; addison disease.On (b)(6) 2014 the patient had 6 falls in last 2 weeks due to imbalance and leg weakness (legs gave out); admits hitting head 3 times.Also she complained of increased numbness and tingling in extremities.Assessment: back pain; neuropathic pain of lower extremity.On (b)(6) 2014 the patient presented with constant back pain.Her left foot was swollen and painful due to fall 2 days ago; also dropped a can on the same foot.Assessment: back pain; foot injury.On (b)(6) 2014 the patient presented with severe pain in back and on left side (affected left side of face as well).Assessment: 1.Visit for screening mammogram 2.Back pain 3.Screening of lipoid disorders 4.Copd.On (b)(6) 2014 the patient presented for a follow up office visit.Assessment: 1.Back pain (primary) 2.Addison disease 3.Neuropathic pain of lower extremity.On (b)(6) 2014 the patient presented with complaints of increased back pain.Assessment: 1.Back pain (primary) 2.Addison disease 3.Gerd (gastroesophageal reflux disease) 4.Neuropathic pain of lower extremity 5.Copd.On (b)(6) 2014 patient stated this past year her rods broke and she had surgery to fix them.Now they snapped again.She is having surgery again to replace the rods.On an unknown date in (b)(6) 2014 the patient underwent a repair of fractured hardware in back.On (b)(6) 2014 the patient presented with pain in whole back and neck.Patient stated that she is unable to do anything with the broken rods and last week she heard another new snap in back.On (b)(6) 2014 the presented for pre op clearance of lumbar revision.Assessment: 1.Back pain (primary) 2.Addison disease 3.Preoperative clearance 4.Htn (hypertension).On (b)(6) 2014 the patient presented for a follow up and reported that her back pain was well controlled.Assessment: status post lumbar surgery.On (b)(6) 2014 the patient was discharged from the hospital.On (b)(6) 2014 the patient presented for a follow up and has cold and coughing up dark green phlegm.Assessment: 1.Back pain 2.Addison disease 3.Seizure disorder 4.Anemia 5.Htn (hypertension) 6.Hypothyroidism 7.Uri (upper respiratory infection).On (b)(6) 2015 the patient presented for a follow up and complained of right arm pain.The pain in between shoulder and elbow.1.Addison disease 2.Seizure disorder 3.Gerd (gastroesophageal reflux disease) 4.Back pain 5.Neuropathic pain of lower extremity 6.Copd 7.Hypothyroidism 8.Arm pain, right.The patient underwent x-rays of the right humerus due to pain.Impression: no fracture or dislocation.X-rays of the right shoulder showed calcific tendinosis of the rotator cuff and moderate degenerative changes of the acromioclavicular joint.On (b)(6) 2015 the patient presented with right shoulder problems with radiation down her arm.She had some numbness in the arm.Rom of her neck is decreased with pain radiating to the right shoulder area.Tenderness is present over the right neck and shoulder area generally.Impression: bursitis of the right shoulder as well as cervical spine complaints.On (b)(6)2015 the patient presented for a follow up.She noted increase in lower back pain.Assessment: 1.Visit for screening mammogram 2.Neuropathic pain of lower extremity 3.Hypothyroidism 4.Addison disease 5.Anemia 6.Gerd (gastroesophageal reflux disease).On (b)(6) 2014 the patient underwent x-ray of lumbar spine due to back pain.On (b)(6) 2014 the patient underwent x-ray of entire spine due to scoliosis.On (b)(6) 2014 the patient underwent radiology due to scoliosis.On (b)(6) 2014 the patient underwent x-ray of entire spine due to scoliosis.On (b)(6) 2014 the patient underwent x-rays of cervical, thoracic, lumbo-sacral spine due to indications of scoliosis.On (b)(6) 2013 the patient presented with presented with inability to stand up straight.The patient presented with the pre op diagnoses of spinal stenosis, flat back deformity.The patient underwent the following procedures: 1.T.L.I.F.L4-l5 with 13 mm cage.2.T.L.I.F.L5-s1 with 12 mm cage.3.L3 pedicle subtraction osteotomy.4.Smith-peterson osteotomies t5-t6, t6-t7, t7-t8, t8-t9, t9-t10.5.T3 to s1 segmental spinal instrumentation (5.5/6.0 mas with a 5.5 cobalt chrome rod).6.Bilateral iliac fixation.7.T3 to s1 bilateral posterolateral fusion using local autogenous bone and 1 large kit of bone morphogenic protein and 10 ml of bone graft per op notes, once all the instrumentation was in place, the t.L.I.F was performed at l4-l5 and l5-s1.This was done on the left-hand side.A 13 mm cage was filled with autogenous bone and placed at l4-l5 and a 12 mm cage was placed at l5-s1.Then compression was performed across the osteotomy sites.The ap 3-foot and lateral 3-foot films were obtained, which showed good coronal and sagittal balance.The wound was copiously irrigated throughout the case.The bone graft, which was ample, was mixed with 1 large kit of bone morphogenic protein and 10 ml of bone graft.The bone graft was placed after final torquing was performed.No patient complications were noted.On (b)(6) 2014 the patient presented with the pre op diagnoses of spinal stenosis, flat back deformity, nonunion.The patient underwent the following procedures: d.L.I.F l2-l3, l3-l4 with 10 x 50 mm 6-degree offset peek cages for fusion with bmp and bone graft.Per the op notes, at l2-l3 and l3-l4 level, the cage filled with bmp and bone graft was placed and they were felt to be in excellent position, both ap and laterally.No patient complications were noted.On (b)(6) 2014 the patient presented with the pre op diagnosis of non union.The patient underwent the following procedures: 1.Re instrumentation l1 to s1 2.L1 to s1 fusion using 1 large kit of bone morphogenic protein and 10 ml of bone graft.3.Removal of segmental spinal instrumentation.4.Exploration of fusion along with l1 to s1 re instrumentation and l1 to s1 bilateral posterolateral fusion.Per the op notes, decortication was performed from l2 to s1.There was no obvious area of nonunion.The local bone and 1 large kit of bone morphogenic protein, 10 ml of bone graft, as well as vancomycin powder were placed.Ap and lateral image showed good position of the instrumentation.The wound was copiously irrigated before decortication and before the placement of the bone graft.The bone graft was then placed.No patient complications were noted.On (b)(6) 2012 the patient presented with the complaint of lower back and bilateral leg pain.Scoliosis x-rays were obtained in which she stands decompensated to the right.Findings: marked kyphoscoliosis with marked sagittal balance.On (b)(6) 2013 the patient presented for a follow up visit.The patient complained of low back pain and about progression of her deformity.On (b)(6) 2013 the patient was status post t3 to the pelvis with a pedicle subtraction osteotomy and multilevel tlif¿s.X-rays showed that her instrumentation was intact and there was no evidence of loosening.On (b)(6) 2013 the patient presented for her second post operative visit following a fusion surgery.The patient reported that her pain persists and also she needs pain medicine.Scoliosis x-rays showed that the instrumentation was in good position and no evidence of loosening or breakage of instrumentation.On (b)(6) 2013 the patient presented for a follow up and reportedly indicated that she was having a lot of discomfort.Scoliosis films showed that she had a little bit breakdown at the top of the construct but not severe or significant.On (b)(6) 2014 the patient presented for a follow up visit.She developed neck pain, bilateral arm pain, increased mid <(>&<)> lower back pain.Scoliosis x-rays showed that the instrumentation was in good position and no evidence of loosening or breakage of instrumentation.Cervical spine showed evidence of mild, diffuse degenerative changes.On (b)(6) 2014 the patient presented for a follow up visit and she felt a crack in the lower back.Scoliosis x-rays showed that the inst rumentation was in good position and no evidence of loosening or breakage of instrumentation.On (b)(6) 2014 the patient presented for a post operative visit and she continues with significant pain.Scoliosis x-rays showed that the instrumentation was in good position and the new interbody cages were in good position as well as the new bridging rods.On (b)(6) 2014 the patient presented for a follow up visit and reported that she has had falls recently, in which she developed increasing pain.Scoliosis x-rays showed that the instrumentation was in good position and also she does stand positive secondary to marked pjk.On (b)(6) 2014 the patient presented for a follow up visit and reported that she leaned over the other day and felt a pop.X-rays showed that the instrumentation was intact and she does have the pjk at the top.On (b)(6) 2014 the patient presented for a follow up visit.The patient felt a snap and had developed increased lower back pain since.Scoliosis x-rays showed that the instrumentation was in position with new fractures in the rods bilaterally, below where the bridging rods were placed.On (b)(6) 2014 the patient presented for a follow up visit and she broke her rods again.The patient was ambulating with a cane.On (b)(6) 2015 the patient presented for a follow up.She continued to experience back pain and now it is more of an upper back pain.Scoliosis x-rays showed that the instrumentation and new bridging rods were in good position.
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Manufacturer Narrative
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(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2004: the patient presented with neck and back pain.She underwent x-rays of cervical spine due to pain post motor vehicle accident.Impression: no evidence of fracture of the cervical spine; minor degenerative change.She also underwent x-rays of the lumbosacral spine.Impression: no evidence of fracture or dislocation; early acetabular spurring and joint space narrowing of the hips.(b)(6) 2007: the patient underwent ct of head-brain due to head injury.Impression: no evidence of acute intracranial event identified.She also underwent x-rays of the skull.Impression: no evidence of depressed injury identified.(b)(6) 2009: the patient presented with history of several falls and neck pain.The pain was described as constant.The patient also had numbness at left arm and weakness at both arms.On (b)(6) 2009, patient underwent mri scan of upper spinal canal due to neck pain.Impression: limited study due to motion artifact; there is however suggestion for midline herniated nucleus pulposes at the c3-4 and at the c4-5 levels.The patient was also given 10 mg of valium orally prior to the mri study for claustrophobia.(b)(6) 2013: the patient presented for a follow-up of chronic back pain with radicular pain to her bilateral legs.(b)(6) 2013: the patient presented for a follow-up of chronic back pain.Her pain was getting worse and was described as nagging, sharp, throbbing and grabbing.She also had difficulty walking due to her pain.Assessment: chronic pain with opioid dependence; insomnia; headaches; anxiety; anorexia.
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Event Description
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It was reported that on (b)(6) 2008: the patient underwent ct scan of lumbar and sacral spine.Impression: mild broad-based disc protrusion at l5-s1 creating a mild central and mild bilateral neural foraminal stenosis.Remaining levels were unremarkable.
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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) 2013, the patient presented for pathology examinations.(b)(6) 2014: the patient underwent neurovascular assessment lower extremity, pain assessment, neuro checks, incentive spirometry and other patient care.The patient underwent radiological test of the chest and respiration therapy.Patient's active problems list: addison's disease, anxiety, pressure sore, constipation, chronic obstructive pulmonary disease, depression, fibromyalgia, hiatal hernia, hypertension, hypothyroid, irritable bowel, migraines, pain, scoliosis, seizure.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: on (b)(6) 2005 per billing records, the patient underwent ct of head w/o contrast and ultrasound carotid bilateral.(b)(6) 2005 per billing records, the patient underwent x-rays for chest and ultrasound of the abdomen.(b)(6) 2005 per billing records, the patient underwent ct of abdomen and pelvis with contrast.(b)(6) 2005 per billing records, the patient underwent ct of lumbar spine.On (b)(6) 2005, (b)(6) 2006, (b)(6) 2006, (b)(6) 2006 per billing records, the patient underwent x-rays of chest.(b)(6) 2005 per billing records, the patient underwent x-rays of chest, ekg and ct of head without contrast.On (b)(6) 2005 per billing records, the patient underwent cardiac sonograph, mri brain and mra head w/o contrast.(b)(6) 2005 per billing records, the patient underwent x-rays of chest, ekg (b)(6) 2005 per billing records, the patient underwent ct of head w/o contrast on (b)(6) 2005 per billing records, the patient underwent ct of abdomen and pelvis with contrast.On (b)(6) 2006 per billing records, the patient underwent ct of head and angio chest w/o contrast, ct of chest with contrast and ct of lower extremity and ultrasound study.On (b)(6) 2006 per billing records, the patient underwent echocardiography.On (b)(6) 2006 per billing records, the patient underwent ct of abdomen, pelvis with contrast.On (b)(6) 2006 per billing records, the patient underwent ct of angio chest w/o contrast, ct of chest with contrast and ct of lower extremity.On (b)(6) 2006 per billing records, the patient underwent ekg and x-rays of the chest.On (b)(6) 2007 per billing records, the patient underwent x-rays of chest, ct of angio chest w/o contrast, ct of chest with contrast, ct of lower extremity, and echocardiography.On (b)(6) 2007 per billing records, the patient underwent ct lumbar spine with contrast.On (b)(6) 2012 per billing records, the patient underwent x-rays of thoracic spine region.On (b)(6) 2012 the patient came for an office visit.The patient underwent x-ray of lumbar spine region.(b)(6) 2013: the patient underwent x-ray of spinal region.On (b)(6) 2013 the patient came for a post-op follow up.The patient underwent x-ray of thoracic spine region.(b)(6) 2013: the patient underwent x-ray of thoracic spine region.On (b)(6) 2044 the patient underwent mri of cervical spine region.On (b)(6) 2015 per billing records, the patient underwent dx x-ray/chest.On (b)(6) 2015 per billing records, the patient underwent ct scan of head.(b)(6) 2007 - per medical records, patient presented for follow up.(b)(6) 2011 - per medical records, patient presented for a follow up.(b)(6) 2012 - per medical records, patient presented for follow up.(b)(6) 2012 - per medical records, patient presented for some support device fitting and insertion.(b)(6) 2015, per medical records, patient presented for a follow up.(b)(6) 2013 - per medical records, patient underwent pathology examination of tissue using a microscope.(b)(6) 2013 - per medical records, patient presented for follow up.(b)(6) 2014 - per medical records, patient presented for x-ray /chest (b)(6) 2014, (b)(6) 2014 - per medical records, patient underwent pathology examination of tissue using a microscope.(b)(6) 2014 - per medical records, patient presented for a follow up.(b)(6) 2015 per billing records, the patient underwent dx x-ray of chest and of spine of neck (b)(6) 2015, per medical records, patient presented for a follow up.On (b)(6) 2006 per billing records, the patient underwent electrocardiogram.On (b)(6) 2007 as per billing records, the patient underwent ultrasound of chest.On (b)(6) 2009, patient underwent mri scan of upper spinal canal.On (b)(6) 2009, patient underwent x-ray of lower and sacral spine.On (b)(6) 2011 the patient underwent x-ray of right and left hand, wrist and foot minimum of 3 views, knee 3 views and x-ray of sacroiliac joints less than 3 views.(b)(6) 2012, (b)(6) 2012 patient underwent mri scan of brain on (b)(6) 2012 (b)(6) 2012-(b)(6) 2012, (b)(6) 2012-(b)(6) 2012, (b)(6) 2012-(b)(6) 2012, (b)(6) 2012 the patient underwent therapeutic exer cise to develop strength, endurance, range of motion, and flexibility on (b)(6) 2012 the patient underwent physical therapy evaluation.On (b)(6) 2012 the patient came for an emergency department visit with a moderately severe problem.(b)(6) 2013.Patient underwent x-ray of middle and lower spine.On (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013-(b)(6) 2013, (b)(6) 2013 the patient came for an office visit.The patient underwent drug screen.On (b)(6) 2014 as per billing records, the patient underwent electrocardiogram.On (b)(6) 2014 (b)(6) 2014 the patient came for an office visit.(b)(6) 2014 the patient also underwent x-ray of chest, 2 views, front and side.On (b)(6) 2014 the patient came for an office visit for assessment and management.(b)(6) 2013: impression: stable changes of extensive thoracolumbar sacroiliac spinal fusion.(b)(6) 2014 patient presented for med.Refills.(b)(6) 2014.Addison's disease (glucocortoid deficiency), cannabis abuse-unspec, cervical disc w/o myelpy dsplcrnnt, lumbar disc w/o myelpy dsplcmnt, neuritis, lumbosacral nos, scoliosis (b)(6) 2014 the rods were broken.The old bridging rod was removed.The new dominos sites were repaired between s1 and iliac wing (b)(6) 2014 patient presented for follow-up.(b)(6) 2015 patient presented to office due to pain in back, neck legs and arms.(b)(6) 2015 patient presented for neurological: numbness, a burning sensation and tingling.Psychiatric: anxiety.Upper extremity: no swelling, tenderness, crepitation or discoloration.Full range of motion, smooth, without limitations.No luxation or subluxation.Strength and tone: hand grip, wrist extension <(>&<)> flexion, arm/shoulder abduction, elbow extension and flexion equal and symmetric.Biceps and triceps equal and symmetric.Lower extremity: no swelling, tenderness, crepitation or discoloration.Full range of motion, smooth, without limitations.No luxation or subluxation.Strength and tone: peroneal eversion, dorsiflexion, plantar flexion and extension, knee flexion and extension are equal and symmetric 5/5.(b)(6) 2015 patient presented to office for follow-up.She continued to experience upper back pain.Scoliosis x-rays showed the instrumentation in good position as well as the new bridging rods in good position as well.(b)(6) 2015, (b)(6) 2015 patient presented for follow-up study.(b)(6) 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015, (b)(6) 2015 nurse telephone/conversation note for thoracic back pain, chronic use of opiate drugs therapeutic purposes, low back pain, post-laminectomy syndrome, idiopathic scoliosis (and kyphoscoliosis) (b)(6) 2015 patient presented for follow-up with thoracic back pain, chronic use of opiate drugs therapeutic purposes, low back pain, post-laminectomy syndrome, idiopathic scoliosis (and kyphoscoliosis), physical exam was done and had the following result thoracic spine: surgical incision well healed surgical scar, but was clean, dry and intact.Lumbosacral spine: surgical incision, well healed surgical scar, but was clean, dry and intact.Tenderness on palpation of the left: paraspinal.Tenderness on palpation of the right: paraspinal.Rom: range of motion is limited.Range of motion increases pain.Upper extremity: no swelling, tenderness, crepitation or discoloration.Full range of motion, smooth, without limitations.No luxation or subluxation.Strength and tone: hand grip, wrist extension <(>&<)> flexion, arm/shoulder abduction, elbow extension and flexion equal and symmetric.Biceps and triceps equal and symmetric.Lower extremity: no swelling, tenderness, crepitation or discoloration.Full range of motion, smooth, without limitations.No luxation or subluxation.Strength and tone: peroneal eversion, dorsiflexion, plantar flexion and extension, knee flexion and extension are equal and symmetric 5/5.Patient pain comes and goes was very sever, due to pain normal sleep was reduced by less than 50%, can't sit and stand for long hours and not able to walk, pain is rapidly worsening.
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Event Description
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It was reported that on (b)(6) 2011: patient presented for office visit.Review of systems reveals that patient is positive for joint pain, joint swelling, dry mouth, alopecia, shortness of breath, myalgia, blood clots and fatigue.Impression: copd, chronic pain on (b)(6) 2011 the patient underwent x-ray of right and left hand, wrist and foot minimum of 3 views, knee 3 views and x-ray of sacroiliac joints less than 3 views.Patient underwent x-ray of bilateral knees.Impression: degenerative changes seen in the hands , knees and feet; scattered cystic densities in the hands, wrists and feet bilaterally.This can be seen in rheumatoid arthritis in the appropriate clinical setting; findings consistent with sacrolitis, more prominent on the right than on the left.On (b)(6) 2012:patient presented for consultation for increased fatigue, back pain, leg weakness and recent falls.Recent laboratory results demonstrated a slightly elevated esr and rheumatoid factor, however these are not indicative of a connective tissue disorder.After 2 exams and assessment of radiologic imaging it is believed that: fibromyalgia is the primary cause of her pain; lower extremity pain secondary to fibromyalgia and deconditioning contributing to falls; mild/ moderate radiculopathy as per mri¿s and emg¿s; mild elevation of esr and rf, not indicative of a connective tissue disorder at this time.On (b)(6) 2013 that patient was presented for office visit.Assessments: chronic pain syndrome; degeneration of lumbar or lumbosacral intervertebral disc; scoliosis; opioid type dependence, episodic abuse.
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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 supportive psychotherapy, medication monitoring and medication teaching.Patient had diagnosis of major depressive disorder and generalized anxiety disorder.On (b)(6) 2013, (b)(6) 2014: patient presented for a psychiatric follow-up.Assessment: major depressive disorder, recurrent, moderate; generalized anxiety disorder.
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Search Alerts/Recalls
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