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

Catalog Number 7510800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atherosclerosis (1728); Chest Pain (1776); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Urinary Tract Infection (2120); Weakness (2145); Tingling (2171); Stenosis (2263); Sinus Perforation (2277); Depression (2361); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Lethargy (2560)

Event Type  Injury  

Event Description

It was reported that the patient underwent a plif at l5-s1 using an interbody cage and rhbmp-2/acs.The interbody cage was packed with bmp.The patient also underwent a posterolateral fusion at the same level.Post-op, the patient developed severe injuries including but not limited to severe pain, great emotional distress, and mental anguish.

Manufacturer Narrative

(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

On (b)(6) 2001 the patient presented for follow-up and reported arm, neck and shoulder pain.She had been using a sling for support.On (b)(6) 2001 the patient presented for follow-up and reported arm pain, weakness and headaches.On (b)(6) 2001 the patient presented for follow-up and reported arm pain and weakness.She also reported increasing color changes in her right arm and says she feels excessively hot or cold in her arm.Also headache were coming every other day.On (b)(6) 2001 patient presented for follow-up and reported headache and sharp continuous right arm pain.On (b)(6) 2001 the patient also underwent the following procedure: right stellate ganglion block.The patient tolerated the procedure well.On (b)(6) 2002 patient presented for follow-up and reported headache and sharp continuous right arm pain.She also claimed visual symptoms such as blurred vision, tunnel vision and some double vision.On (b)(6) 2002 the patient underwent the following procedure: right stellate ganglion block.The patient tolerated the procedure well.On (b)(6) 2002 the patient underwent the following procedure: right stellate ganglion block.The patient tolerated the procedure well.On (b)(6) 2002 patient presented for follow-up and reported headache and sharp continuous right arm pain.She reported that nortriptyline caused her tongue to swell and the injection was not helping.On (b)(6) 2002 patient presented for follow-up and reported headache and sharp continuous right arm pain.She reported a mild concussion involving a tda and was waiting for a spinal cord stimulator.On (b)(6) 2009 patient underwent ct head without contrast.Impression: limited unenhanced ct brain shows no focal abnormalities.If symptoms are persistent, additional imaging additional imaging evaluation such as mri should be considered.

Manufacturer Narrative

(b)(4).

Event Description

Per medical records, it was reported that on (b)(6) 2005 the patient presented with chief complaints of abdominal pain.On (b)(6) 1993 the patient presented for office visit with chief complaint of acute frontal sinusitis.On (b)(6) 1995 the patient presented for office visit with chief complaint of contusion of thigh.On (b)(6) 1995 the patient presented for office visit with chief complaint of headache.On (b)(6) 1995, (b)(6) 2014, (b)(6) 2015 the patient presented for office visit with chief complaint of abnormal pap cervix.On (b)(6) 1996 the patient presented for follow up.On (b)(6) 1997, (b)(6) 2014 the patient presented for office visit with chief complaint of unspecified chest pain.On (b)(6) 2005 the patient presented for office visit with chief complaint of unspecified skin disorder.On (b)(6) 2005 , (b)(6) 2006 the patient presented for office visit.On (b)(6) 2005 , (b)(6) 2006 , (b)(6) 2008 the patient presented for office visit with chief complaint of cervical disdisplacement.On (b)(6) 2005 the patient presented for office visit with chief complaint of irritable bowel syndrome.On (b)(6) 2005 the patient presented for office visit with chief complaint of atherosclerosis.On (b)(6) 2006 , (b)(6) 2009, (b)(6) 2010, (b)(6) 2011, (b)(6) 2012 the patient presented for office visit with chief complaint of lumbago.On (b)(6) 2008 the patient presented for office visit with chief complaint of exostosis of jaw.On (b)(6) 2009, (b)(6) 2010 the patient presented for office visit with chief complaint of dysthymic disorder.On (b)(6) 2010 , (b)(6) 2012 the patient presented for office visit with chief complaint of joint pain shoulder.On (b)(6) 2010, (b)(6) 2011, (b)(6) 2012 , (b)(6) 2014 , (b)(6) 2013, (b)(6) 2015 the patient presented for office visit with chief complaint of cervicalgia.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2014 the patient presented for office visit with chief complaint of chronic pain.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014, (b)(6) 2015 the patient presented for office visit with chief complaint of post-laminectomy syndrome.On (b)(6) 2012 the patient presented for office visit with chief complaint of dermatitis.On (b)(6) 2012, (b)(6) 2015 the patient presented for office visit with chief complaint of cervical disc degeneration.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015 the patient presented for office visit with chief complaint of major depression psychotic.On (b)(6) 2013 the patient presented for office visit with chief complaint of routine gynecological exam.On (b)(6) 2013 the patient presented for office visit with chief complaint of condylomata acuminatum.On (b)(6) (b)(6) 2014, (b)(6) 2015 the patient presented for office visit with chief complaint of hypertension.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2013, the patient presented for follow up visit.On (b)(6) 2014, the patient presented for follow up visit.On (b)(6) 2015, the patient presented for follow up visit.On (b)(6) 2014, (b)(6) 2015, the patient presented for follow up visit.On (b)(6) 2015: patient visited the facility due to neck and lower back pain.On (b)(6) 2015 the patient presented for medicine refill.On (b)(6) 2015, the patient visited the facility with complaint of low back pain radiating to left ankle , right ankle , calfs , feet thighs.The patient underwent urine drug screening.On (b)(6) 2015, the patient was admitted in emergency room due to convulsions nec.Also underwent ct head which indicated that patient was actively having pseudoseizure.The patient also underwent cbc, urinalysis.On (b)(6) 2015: the patient underwent cbc w/auto differential and bmp ( basic metabolic panel ) (b)(6) 2015, the patient presented with pre-op diagnosis of angina/ chest pain.The patient underwent following procedures: coronary angiography.Right the femoral axis.Left ventriculogram.On (b)(6) 2015, the patient presented with diagnosis of right lower quadrant pain and urinary tract infection.The patient underwent pathology examinations.The patient also had ct for pelvis and abdomen.Impression : focal loop of moderately dilated small bowel within the right upper quadrant.On (b)(6) 2015,the patient visited due to pelvic pain and requested for medicine refill.On (b)(6) 2015, the patient presented for follow up of ¿rlq-low¿.Ct of abdomen study indicated focal loop of moderately dilated small bowel within the right upper quadrant.On (b)(6) 2015, the patient presented for ultrasound of pelvis.Impression : the uterus and adnexae are not seen.The ovaries may be obscured by overlying bowel gas and cannot be assessed by this modality.On (b)(6) 2015, the patient was admitted with diagnosis of cardiac catheterization.The patient underwent ultrasound arterial system right lower extremity.Impression : normal exam.On (b)(6) 2016, the patient presented with constipation difficulty and described it as burning.Also experiencing abdominal pain , bloating , nausea and pain.On (b)(6) 2016, the patient presented with complaint of right lower quadrant pain.The patient underwent ct abdomen and pelvis with and without contrast.Impression : atherosclerotic disease; no gi or gu tract obstruction.No bowel wall thickening or pneumatosis; normal ct appearance of the right groin without evidence for fluid collection or mass lesion.No vascular abnormality appreciated.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that (b)(6) 2011 the patient with a history of intractable back and leg pain presented with pre op diagnoses of degenerative disk disease with instability and radiculopathy at l5-s1.The patient underwent the following procedures: 1.Bilateral non segmental pedicle screw instrumentation, l5-s1.2.Posterior interbody arthrodesis using peek cage, bmp and locally harvested bone graft for fusion of l5-s1.3.Posterior lateral arthrodesis using compression resistant matrix, bmp and locally harvested bone graft.4.Posterior lateral decompression at l5-s1 to decompress the l5 nerve root.5.Lumbar decompression at l5-s1 to decompress the s1 nerve root.6.Insertion of biomechanical device at l5-s1.Per the op notes, an 8 mm peek cage was brought into the field.It was filled with bmp soaked sponge and locally harvested bone, which had been previously morselized.A construct of compression resistant matrix, bmp and locally harvested bone was placed into the anterior disk space and tamped down.The peek cage was then inserted and rotated and tamped anteriorly.Once this was done, posterior lateral arthrodesis was completed using compression resistant matrix, bmp sponge and locally harvested bone graft.This construct spanned transverse processes of ls to the sacral ala, which had been previously decorticated.Lateral radiograph showed the pedicle screws and the interbody graft were in good position.No patient complications were noted.(b)(6) 2011 the patient underwent x-ray of the lumbar spine.Findings: two surgical screws are seen in projection with the l5 vertebra and two are seen in projection with the s1 vertebra.There is now a spacer at the level of the l5-s1 disk space.The alignment appears anatomic.(b)(6) 2011 the patient was discharged home with the following diagnoses: 1.Lumbar degenerative disk disease.2.Radiculopathy.On (b)(6) 2011 the patient presented with complaints of being very anxious, nervous, stressed and depressed.The patient denied having any hallucinations.(b)(6) 2011 the patient was status post op tlif l5-s1.(b)(6) 2011 the patient was 1month out from a lumbar fusion.She still complained of quite a bit of pain.Musculoskeletal exam showed right hand swollen tender and back review revealed spinal tenderness in the lumbar region, spasm, decreased range of motion.Assessment: lumbago, post laminectomy syndrome lumbar region, sciatica, dysthymic disorder.(b)(6) 2011 the patient presented for the follow up and underwent ct of lumbar spine due to low back pain.Impression: 1.Posterior migration of interosseous spacer at the lumbosacral junction, with migration of an osseous fragment and probably some soft tissue component into the central and left l5-s1 canal and left foramen.2.Other hardware position looks anatomic and no other pathology is evident.(b)(6) 2011 the patient was status post a lumbar fusion.She has obtained a ct scan, which showed slight posterior migration of her inner body graft.Otherwise, the ct was okay.(b)(6) 2011 the patient underwent mri of the cervical spine due to neck pain.Impression: mildly progressive cervical disk degeneration at c4-c5 and c5-c6.A right c5-c6 foramen stenosis has developed and is probably from uncovertebral spur.(b)(6) 2011 the patient presented for the follow up on neck pain.The patient reported constant ache in neck and complained of shooting pain.On (b)(6) 2011 patient presented for follow up with low back pain, neck pain.Physical exam of neck was normal except pain stiffness, spasm, and somatic dysfunction.Musculoskeletal exam was normal except pain and swelling right wrist and hand.Back review was normal except spinal tenderness in the lumbar region, spasm, decreased range of motion.Assessment: lumbago, cervical disc disease, displaced cervical intervert disc, dysthymic disorder, and headache.(b)(6) 2011 the patient underwent x-ray of the chest pre-op to acdf.Impression: normal chest.On (b)(6) 2011 the patient complained of her last appetite.(b)(6) 2011 the patient with a history cervical pain presented with the following pre op diagnoses: 1.Herniated cervical disk, c4-5.2.Herniated cervical disk, c5-6.The patient underwent the following procedures: 1.Anterior cervical diskectomy with fusion using structural arthrodesis and demineralized bone graft at c4-5.2.Anterior cervical diskectomy with arthrodesis using structural bone graft and demineralized bone at c5-6.3.Anterior cervical instrumentation at c4-5, c5-6.4.Modification of structural bone graft.Per the op notes, progenix demineralized bone graft was placed and it was impacted into position at c5-6, c4-5 levels.An anterior cervical plate was then affixed to the cervical spine using 2 screws in c4, 2 in c5, and 2 in c6.Intra-op x-rays of cervical spine showed surgical localization device was positioned at the c5-c6 level.The visualized vertebral bodies show anatomic alignment.Another x-ray of cervical spine showed that there was interval placement of anterior cervical spine fusion device at the c4 through c6 levels.There was interval placement of intervertebral disk spacer at c4-c5 and c5-c6.Alignment was anatomic.There was no evidence of acute hardware complication.No patient complications were noted.(b)(6) 2011 the patient was discharged home with the discharge diagnosis of cervical herniated disk at c4-5, c5-6.(b)(6) 2011 the patient was admitted due to chronic neck pain.(b)(6) 2011 the patient was status post anterior cervical discectomy and fusion.She also reported left shoulder pain.(b)(6) 2011 the patient presented with a history of chronic neck pain.She stated that since the cool and rainy weather has begun, she has been having increased pain.She was noted to have tenderness to palpation over the lumbar and cervical spinous processes and the paraspinal muscles.She also exhibits allodynia and tenderness to the right hand.On (b)(6) 2011 patient presented for follow up with low back pain, neck pain.Physical exam of neck was normal except pain stiffness, spasm.Musculoskeletal exam was normal except right forearm and hand pain to palpation, sciatic pain to palpation, decreased range of motion.Back review was normal except spinal tenderness in the lumbar region, spasm, decreased range of motion.Assessment: lumbago, cervicalgia, postlaminectomy synd cervical, reflex symp dystrophy upper limb, dysthymic disorder.(b)(6) 2012 the patient presented for the follow up and reported neck pain which was radiating to arm.The patient underwent ct of the cervical spine due to neck pain.Impression: intact hardware with anatomic alignment.On (b)(6) 2012 patient presented for follow up on low back pain and left shoulder pain.Physical exam of neck was normal except pain stiffness, spasm.Musculoskeletal exam was normal except left shoulder swollen tender, decreased range of motion.Back review was normal except spinal tenderness in the lumbar region, spasm, decreased range of motion.Assessment: joint pain shoulder, lumbago, cervicalgia, postlaminectomy synd cervical, reflex symp dystrophy upper limb, dysthymic disorder, chronic airway obstruction other.(b)(6) 2012 the patient presented with low back pain and neck pain.She was noted to have tenderness to palpation over the lumbar and cervical spinous processes and the paraspinal muscles as well.She also exhibits allodynia and tenderness to the right hand.On (b)(6) 2012 patient underwent ct of left shoulder.(b)(6) 2012 the patient presented with joint pain shoulder and underwent ct of the left shoulder.Impression: non displaced mildly comminuted non united fracture of the greater tuberosity.(b)(6) 2012 the patient presented with left shoulder pain which stable and constant.The pain is aching, burning, sharp and throbbing.Ct scan showed fracture.On review of systems, there were fatigue, night sweats, weight loss, anxiety, depression, headache, nocturnal awakening, paresthesia and tingling.Assessment: fracture of greater tuberosity of humerus, closed.(b)(6) 2012 the patient was admitted due to shortness of breath for a week with cough and yellow sputum, chest and abdomen sore from coughing and underwent x-ray of the chest.Impression: normal chest.On (b)(6) 2012, (b)(6) 2012 patient presented with low back pain and neck pain.Patient had weakness in bilateral shoulder and numbness.Physical exam of neck was normal except pain stiffness, spasm.Musculoskeletal exam was normal except pain swelling and erythema of right hand.Assessment: chronic low back pain, cervicalgia, postlaminectomy synd cervical, reflex symp dystrophy upper limb, dy sthymic disorder, chronic airway obstruction other.(b)(6) 2012, (b)(6) 2012, (b)(6) 2012 the patient was admitted due to chronic neck pain.(b)(6) 2012 the patient presented with complex regional pain syndrome and was evaluated for spinal cord stimulator trial.She was psychologically appropriate for installation of spinal cord stimulator.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014 the patient presented with chief complaints of depression.The patient also reported that she fails to see much improvement in her sleep, energy level or motivation to socialize with anyone.Current diagnosis: 1.Major depression, recurrent with psychotic features, 2.Alcohol dependence unspecified, 3.Cocaine dependence, 4.Uncomplicated bereavement.(b)(6) 2012 the patient presented with back pain.Location of pain was upper back, middle back, lower back, legs and right arm and right hand.The patient describes the pain as an ache, burning, sharp, shooting, stabbing and throbbing.Also the patient has joint pain and neck pain.She has tenderness over the cervical spinous processes and bilateral trapezius and rhomboid musculature with significant allodynia and tenderness over the right hand with decreased range of motion secondary to pain.Assessment: cervicalgia, post laminectomy syndrome cervical, crps i of the upper limb, migraine, depression.On (b)(6) 2012 patient presented with the issue of rashes all over.(b)(6) 2012 the patient presented with back pain.Assessment: cervicalgia, post laminectomy syndrome cervical, reflex sympathetic dys trophy of the upper limb.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2013, (b)(6) 2014, (b)(6) 2014 patient presented for check up.Impression: hypertension, chronic back and neck pain.(b)(6) 2012 the patient presented for a psychiatric evaluation and reportedly said that "do not know why i am here." urinalysis was positive for +1 bacteria, however, there was 20-25 epithelial cells, and was obviously a contaminant.The patient was being lethargic, mildly depressed during the exam.The patient was found to have paraspinal fullness in the thoracic spine, greater on the left.Ct of the head without contrast showed no acute intracranial abnormalities.Impression: 1.Altered mental status/delirium.2.Depression.3.Chronic back pain.4.Anxiety.5.Gastrointestinal prophylaxis.6.Deep venous thrombosis prophylaxis.On (b)(6) 2012 the patient presented to the hospital and tested for benzos and barbs.The patient reported that she had a mental breakdown and felt like she was losing it.(b)(6) 2013 the patient presented with back pain.Location of pain was lower back and neck.Pain has radiated to the right arm.The patient describes the pain as an ache, burning, numbness, piercing, sharp and shooting.She also has joint pain, muscle weakness, extremity weakness and numbness in extremities.There was erythema on right hand and severe pain with motion.Assessment: cervicalgia, post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb.(b)(6) 2013 the patient presented with lump/mass in left breast and underwent ma mammogram diagnostic bilateral.Impression: no mammographic evidence of malignancy.(b)(6) 2013 the patient presented with back pain.Location of pain was lower back, neck and right arm.The patient describes the pain as an ache, burning, numbness, sharp, shooting, stabbing and throbbing.She reportedly indicated that she is having difficulty with her legs at night.She also stated "they ache and jerk all night." there was tenderness on cervical spine and moderate pain with motion.Assessment: cervicalgia, post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb, migraine and depression.(b)(6) 2013 the patient presented with back pain.Location of pain was lower back, right hand and neck.The patient describes the pain as an ache, burning, deep, numbness, piercing, sharp, shooting, stabbing and throbbing.She also reported insomnia.There was tenderness on cervical spine, lumbar spine and moderate pain with motion.Assessment: cervicalgia, post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb.(b)(6) 2013: the patient presented for an office visit.Medications were reviewed during the visit.(b)(6) 2013 the patient presented in clinic due to abnormal lab results and the patient's platelet count was worse this month.The patient reportedly said that she feel tired most of the time and has had some unexplained weight gain.(b)(6) 2013 the patient presented with pelvic pain and she described the pain as constant ache.She also reported fatigue and back pain.(b)(6) 2013 the patient was admitted due to high platelets count.Diagnosis: secondary thrombocytopenia.(b)(6) 2013 the patient was admitted with the diagnosis of other non specific findings in blood and underwent ultrasound of the abdomen.Impression: no pathologic findings.(b)(6) 2013 the patient presented in clinic due to abnormal lab results and she reportedly said that she feel very fatigued.(b)(6) 2013 the patient presented with the diagnosis of thrombocytosis and underwent ct guided bone marrow aspiration and biopsy.No patient complications were noted.Interpretation of cytogenetics test: normal female karyotype.Interpretation of flow cytometry study: 1.No detectable flow cytometric evidence of 8-cell or t-cell lymphoid neoplasm, or acute leukemia.2.Maturing granulocytic/monocytic elements exhibit no diagnostic antigenic aberrancies.(b)(6) 2013 the patient presented in clinic for follow up post bone marrow aspiration.She reported fatigue and chronic pain with restless leg syndrome.Assessment: secondary thrombocytopenia, specified diseases of blood and blood-formin, fatigue i malaise.(b)(6) 2013 the patient was admitted with the diagnosis of secondary thrombocytopenia.(b)(6) 2013 the patient presented with back pain.Location of pain was lower back, legs, neck and right hand.The patient describes the pain as an ache, burning, numbness, sharp, stabbing and throbbing.There was tenderness on cervical spine and moderate pain with motion.Assessment: post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb, migraine and depression.On (b)(6) 2013 the patient presented with health problems and was being evaluated for cancer.She also stated that she continues to have problems with depression and neuro-vegetative symptoms of depression.(b)(6) 2013 the patient presented with abnormal pap smear and thrombocytopenia.The patient underwent colposcopy due to vaginal dyspl asia.Impression: low grade dysplasia.Assessment: condyloma.The patient was very fatigued with low energy level.There were generalized weakness and back pain.(b)(6) 2013 the patient was admitted to the er due to altered mental status and hallucinations.The patient was depressed and positive for headaches.On (b)(6) 2013 patient presented with diagnosis of depressive disorder nec and psychotic and chronic pain, anxiety.Patient was psychotic and depressed with suicidal ideation and auditory hallucinations, paranoia.Patient was depressed, confused, rambling and could not focus and not sleeping last 3 days.Patient's neurologic exam revealed severely altered mental status, abnormal gait.Patient underwent psychiatric therapy assessment.Impression: 1.Polysubstance abuse with substance-induced mood disorder with psychosis.2.Gravida 5, para 3, ab 2.3.Status post hysterectomy.4.Status post tubal ligation.5.Status post two small bowel surgeries secondary to blockages, status post appendectomy.6.History of closed head injury.7.History of reflex sympathetic dystrophy involving the right hand.8.Abuse of tobacco with mild to moderate smoker's bronchitis.9.Gastroesophageal reflux disease.10.Frontal headaches.11.Questionable history of seizure disorder.On (b)(6) 2013 patient was discharged with discharge diagnoses of major depressive disorder, recurrent with psychosis, arthritis, chronic neck and back pain.(b)(6) 2014 the patient presented with back pain.Location of pain was lower back, legs and neck.Pain has radiated to the right hand.The patient describes the pain as an ache, burning, deep, numbness, sharp, shooting, stabbing and throbbing.She also reported head ache and insomnia.There was tenderness on cervical spine, lumbar spine and moderate pain with motion.Assessment: post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb, lumbago, migraine and depression.On (b)(6) 2014 patient presented for follow up for ankle pain and swelling, chest pain and not sleeping issue.Impression: hypertension, chronic back and neck pain.(b)(6) 2014, the patient presented with stable, persistent back pain.Location of pain was lower back and neck.Pain has radiated to the bilateral leg and bilateral arm.The patient described the pain as an ache.Assessment: post laminectomy syndrome cervical, reflex sympathetic dystrophy of the upper limb, cervicalgia, migraine and depression.(b)(6) 2014 the patient presented with persistent low back and neck pain, with pain radiating to bilateral leg and bilateral arm.The pain was described as ache, burning, numbness and tingling.Neurologic and psychiatric examination revealed dizziness, extremity weakness and numbness, headache, anxiety, depression and insomnia.Musculoskeletal examination revealed tenderness and moderate pain with motion in cervical and lumbar spine.Assessment: postlaminectomy syndrome cervical; reflex sympathetic dystrophy of the upper limb; migraine; depression; cervicalgia; fatigue/malaise.On (b)(6) 2014 patient underwent bilateral mammogram due to soa, mass in left breast.Impression: stable parenchymal pattern.No evidence of malignancy.Patient also underwent chest x ray due to soa, mass in left breast.Impression: normal chest.(b)(6) 2014: the patient presented for an office visit for medication review.(b)(6) 2014, (b)(6) 2014, (b)(6) 2014: the patient presented with pain in lower back, gluteal area, arms and neck, and radiating to the left calf, right calf, left foot and right foot.The pain was described as ache, burning, deep, discomforting, numbness, piercing, sharp, shooting, stabbing, throbbing, diffuse and dull.Symptoms were aggravated by bending and daily activities.Musculoskeletal examination revealed joint pain, joint swelling, tenderness and moderate pain with motion in lumbar spine, antalgic gait.Neurologic and psychiatric examination revealed anxiety, depression, gait disturbance, dizziness, extremity weakness, seizures, tremors and numbness, headache, anxiety, depression and insomnia.Assessment: postlaminectomy syndrome cervical; reflex sympathetic dystrophy of the upper limb; cervicalgia; lumbago.On (b)(6) 2014 patient presented with chest pain.(b)(6) 2014: the patient presented with shortness of breath and cardiac evaluation.The patient also had occasional chest pain.Examination revealed that the patient also had memory loss, depression, joint pain and myalgia.Impression: unspecified chest pain; benign essential hypertension; personal history of tobacco use; chronic airway obstruction, not elsewhere classified; pure hypercholesterolemia.(b)(6) 2014: the patient presented with chest pain, not otherwise specified.The patient had the principal diagnosis of chr airway obstruct nec and secondary diagnoses of: tobacco use, benign hypertension, pure hypercholesterolemia.The patient underwent echo cardiogram test.Conclusion: 1.Left ventricular chamber size is normal with a diastolic dimension of 4.8 cm.2.The estimated ejection fraction is normal.3.Color doppler study appears to reveal mild aortic insufficiency.4.The transmitral spectral doppler flow pattern is suggestive of impaired left ventricular relaxation.5.Mild tricuspid insufficiency is noted.6.The estimated right ventricular systolic pressure is 38.1 mm hg.The patient also underwent stress test.Conclusion: indeterminate test due to baseline electrocardiogram abnormalities.The patient underwent myocardial perfusion imaging as well.Conclusion: 1.Myocardial perfusion imaging is normal.2.Overall left ventricular systolic function was normal without regional wall motion abnormalities.(b)(6) 2014: the patient presented for an office visit.(b)(6) 2014: the patient presented for follow up pap.The patient also stated that she had a boil on her labia.The patient had the following musculoskeletal symptoms: back pain, bone/joint symptoms.Assessment: abnormal pap smear of cervix; boil.(b)(6) 2014, (b)(6) 2014: the patient presented with pain in lower back, gluteal area, joint pain, right hand and neck, and radiating to the left calf, right calf, left foot and right foot.The pain was described as ache, stabbing, throbbing, diffuse and dull.The pain in lower back was described as chronic.Symptoms were aggravated by bending, sitting, walking and daily activities.Neurologic and psychiatric examination revealed anxiety, depression, gait disturbance, dizziness, extremity weakness, seizures, tremors and numbness, headache, anxiety, depression and insomnia.Assessment: postlaminectomy syndrome cervical; reflex sympathetic dystrophy of the upper limb; cervicalgia; lumbago; other secondary thrombocyotopenia; malignant neoplasm of cervix uteri, unspecified site; migraine; (b)(6) 2014: the patient presented for follow-up regarding shortness of breath, occasional chest pain and back pain.Impression: unspecified chest pain; unspecified essential hypertension; pure hypercholesterolemia.(b)(6) 2011 the patient presented with admit diagnosis of lumb/lumbosac disc degen, the patient underwent x-ray of the lumbar spine.Findings: two surgical screws are seen in projection with the l5 vertebra and two are seen in projection with the s1 vertebra.There is now a spacer at the level of the l5-s1 disk space.The alignment appears anatomic.(b)(6) 2011 the patient had undergone l5-s1 decompression and instrumented fusion (tlif) and was discharged home with the following d iagnoses: 1.Lumbar degenerative disk disease.2.Radiculopathy.(b)(6) 2011 the patient presented with complaints of cervicalgia, principal diagnosis was cervical disc degeneration.The patient und erwent mri of the cervical spine due to neck pain.Impression: mildly progressive cervical disk degeneration at c4-c5 and c5-c6.A right c5-c6 foramen stenosis has developed and is probably from uncovertebral spur.On (b)(6) 2012 the patient presented for spinal cord stimulator trial lead placement procedure.The patient also complained of chronic neck pain.On (b)(6) 2012 the patient presented with complaints of chronic neck pain.(b)(6) 2012 the patient presented with admit diagnosis of drug-induced delirium, the patient presented for a psychiatric evaluation and reportedly said that "i do not know why i am here." urinalysis was positive for +1 bacteria, however, there was 20-25 epithelial cells, and was obviously a contaminant.The patient was being lethargic, mildly depressed during the exam.The patient was found to have paraspinal fullness in the thoracic spine, greater on the left.Ct of the head without contrast showed no acute intracranial abnormalities.Impression: 1.Altered mental status/delirium.2.Depression.3.Chronic back pain.4.Anxiety.5.Gastrointestinal prophylaxis.6.Deep venous thrombosis prophylaxis.(b)(6) 2013 the patient presented in clinic due to abnormal lab results and the patient's platelet count was worse this month.The patient reportedly said that she feel tired most of the time and has had some unexplained weight gain.The patient underwent us abdomen complete, which demonstrated no pathologic findings.

Manufacturer Narrative

Following are the image review findings: (b)(6) 2007 brain mri axial, sagittal view of the brain reveal no enhancing lesion, no midline deviation.No spinal anatomy or pathology is delineated on these studies (b)(6) 2007 shoulder mri normal appearing studies.No signs of rotator cuff tear, fracture are noted.Bone scan no increased uptake is seen within shoulders or spinal tissues.(b)(6) 2007 lumbar series apex left scoliosis with apex at l3 measuring approximately 15 degrees.Lateral view is normal.Minimal sclerosis is suspected at l5.Cervical series three views show flattening of the cervical lordosis in the lower cervical spine.No evidence of previous surgery is seen.Alignment is normal.No signs of fracture.Open mouth view shows normal odontoid and normal lateral mass c1/2 relationships.Right elbow series three views of the right elbow appear normal no evidence of soft tissue swelling, fracture or dislocation is apparent.Right forearm x-rays ap and lateral views of the radius and ulna to include the wrist and elbow are normal.No fracture, dislocation or soft tissue swelling is apparent.(b)(6) 2008 right forearm series two views show normal elbow, wrist and forearm.No fracture, dislocation or soft tissue swelling is seen (b)(6) 2008 right ankle films ap, lateral and mortise views now verify an acute spiral fracture of the distal fibula.Very slight widening of the medial clear space is suspected.(b)(6) 2008 right angle x-rays ap, lateral and mortise views now verify an acute spiral fracture of the distal fibula.Very slight widening of the medial clear space is suspected.(b)(6) 2009 cervical mri small disc herniation is seen at c5/6 with apparent cord signal change.Axial views verify very slight cord compression at this level in midline.(b)(6) 2009 right ankle series slight tilt is seen in the ankle mortise with minimal widening of the medial clear space.Small spur is noted of the medial talus.Lateral and mortise views appear to show a long spiral fracture of the distal fibula above the ankle mortise right foot series three views of the right foot again show apparent widening of the medial clear space of the ankle.Subtalar, midfoot and forefoot appear normal.Again seen is the lateral ankle fracture.There appears to be some degree of remodeling making this appear to be a more chronic injury.(b)(6) 2010 right foot x-rays three views of the right foot again show apparent widening of the medial clear space of the ankle.Subtalar, midfoot and forefoot appear normal.Again seen is the lateral ankle fracture.There appears to be some degree of remodeling making this appear to be a more chronic injury.Right ankle x-rays slight tilt is seen in the ankle mortise with minimal widening of the medial clear space.Small spur is noted of the medial talus.Lateral and mortise views appear to show a long spiral fracture of the distal fibula above the ankle mortise (b)(6) 2010 right foot x-rays three views of the right foot again show apparent widening of the medial clear space of the ankle.Subtalar, midfoot and forefoot appear normal.Again seen is the lateral ankle fracture.There appears to be some degree of remodeling making this appear to be a more chronic injury.Right ankle x-rays slight tilt is seen in the ankle mortise with minimal widening of the medial clear space.Small spur is noted of the medial talus.Lateral and mortise views appear to show a long spiral fracture of the distal fibula above the ankle mortise (b)(6) 2011 chest x-ray pa and lateral views show hilar thickening greater on the right.Otherwise cardiac, pulmonary and bony anatomy appears normal.Lateral view shows normal thoracic kyphosis without evidence of fracture or deformity.Lumbar series ap view shows some enlargement of the descending colon.Lumbar vertebrae show no fracture.There is a slight lumbar apex left scoliosis centered at l3.L5 disc space is slightly narrowed and sclerotic.(b)(6) 2011 lumbar series lateral views show localization probe at the level of the l4 disc.Subsequent film shows pedicle screws placed bilaterally at l5 and s1.No rods or spacer have been yet applied.Next film shows placement of crescent type interbody spacer.(b)(6) 2011 lumbar ct scout film documents screws, rods and spacers spanning the l5 disc space in satisfactory position.Axial views appear to show the screws in good position with a complete laminectomy at l5.Some degree of heterotopic bone appears to have developed behind the spacer on the left.Sagittal views show apparent heterotopic bone behind the l5 disc (b)(6) 2011 cervical mri sagittal views show advanced disc degeneration with kyphosis at c4 and c5.Indentation of the ventral cord appears to occur at these levels due to bulging discs and cervical alignment.Right-sided foraminal narrowing appears at c5.(b)(6) 2011 chest x-ray pa and lateral views show hilar thickening greater on the right.Otherwise cardiac, pulmonary and bony anatomy appears normal.Lateral view shows normal thoracic kyphosis without evidence of fracture or deformity.(b)(6) 2011 cervical x-rays two lateral films taken.The first shows localization with needle at c5/6.The patient is noted to be edentulous.The second film shows a completed acdf with spacers and plate spanning from c4 to c6.The construct appears in good position.(b)(6) 2012 cervical ct multiple axial views show a well-positioned construct from c4 to c6 with plate and screws secured to c4, c5 and c6.Interbody cornerstone spacers are present and bone appears to span the instrumented levels.No evidence of nerve compression is seen.3d, coronal and sagittal reconstructions add no additional data.(b)(6) 2012 shoulder ct left axial, coronal and sagittal reconstructions are provided that appear to show fragmentation of the greater tuberosity consistent with fracture.The fragments are not displaced.No additional fractures are appreciated in the articular surface of the humerus or scapula.Soft tissues appear intact.(b)(6) 2014 chest x-ray pa and lateral views show hilar thickening greater on the right.Otherwise cardiac, pulmonary and bony anatomy appears normal.Lateral view shows normal thoracic kyphosis without evidence of fracture or deformity.Mammogram no spinal pathology imaged.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2007: patient presented for follow up.(b)(6) 2014, (b)(6) 2015: patient presented for follow up.(b)(6) 2015: patient presented for follow up on breast lump.(b)(6) 2015: patient underwent bilateral mammograms due to breast mass.(b)(6) 2007: patient presented with the problems of depression and nervousness.Patient had decreased sleep and she worried a lot.Patient had been paranoid and depressed.Patient was depressed and anxious.Patient admitted to auditory and visual hallucinations, paranoid thoughts.Assessment: axis i psychosis, nos.Axis ia rule out major depressive disorder with psychotic features.Axis ib history of poly-substance dependence.Axis ii deferred.Axis iv severe.Axis v gaf 45-55.(b)(6) 2007: patient presented for follow up.Diagnoses: major depression.Alcohol dependence.Cocaine dependence.(b)(6) 2008: patient presented with the problems of depression and crying spells.Summary: depression, anxiety.Diagnoses: major depression, recurrent with psychotic features, alcohol dependence , cocaine dependence (b)(6) 2014, (b)(6) 2014, (b)(6) 2015, (b)(6) 2015: patient presented for follow up.Current diagnosis: major depression, recurrent with psychotic features, alcohol dependence unspecified, cocaine dependence, uncomplicated bereavement.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient presented for follow-up.She stated that she feels depressed, anxious, irritable and angry.On (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient presented for follow-up and stated that there is no significant improvement or deterioration in moods.Still depressed and anxious.Diagnosis: major depression, recurrent, with psychotic features, alcohol dependence unspecified, cocaine dependence, uncomplicated bereavement.On (b)(6) 2013; (b)(6) 2014; (b)(6) 2015: under case management program, the patient was seen at home/ office on these dates and counseled on her health conditions, particularly on tackling depression and grief.On (b)(6) 2015: patient presented for follow-up and stated back pain problem.On (b)(6) 2015: patient presented for an office visit.Reportedly, she had a recent heart cath, minor blockage, had 2 angioplasty, out-patient, feels a little sore.States other than that she has been fine, sleep is down.On (b)(6) 2015 patient presented for an office visit with complaints of restless leg syndrome and sleep disturbance.

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) 2010, the patient underwent following procedure : bithermal air caloric tests, spontaneous gaze; up/down/left/right directional gaze, gaze with fixation, smooth pursuit tracking.4 hz test, 30 deg.Saccades test; horizontal and vertical head rotation tests, torsion swing w/wo fixation tests, positional tests, bidirectional optokinetic test, and left/right dix-hallpike maneuver.Impression: the tracking and optokinetics are consistent with mild -cns dysfunction; consider additional neurological testing if there is clinical correlation to central dysfunction such as a ct or mri of the brain; all other findings are within normal limits.On (b)(6) 2010, the patient presented with pre-op diagnosis of low back pain and had mri of lumbar spine.Impression: left paracentral l5-s1 disc herniation with bilateral neural foraminal encroachment left greater than right related to lateral bulging of the disc; mild bulging disc at l4-5; there is no acute fracture or high grade spinal stenosis.Impression from cervical mri : prominent anterior impression on the thecal sac at c5-6 related to a combination of central disc herniation and osteophyte formation with moderate bilateral neural foraminal encroachment related to lateral bulging of the disc and hypertrophic facet joint change; mild bulging disc at c4-5 and c6-7; there is no focal cervical spinal cord signal abnormality.On (b)(6) 2010, the patient presented for nerve conduction studies.

• 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 Key: 4217225
• MDR Text Key: 4968629
• Report Number: 1030489-2014-04186
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• 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: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2013
• Device Catalogue Number: 7510800
• Device Lot Number: M111054AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 68