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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ossification (1428); Syncope (1610); Diarrhea (1811); Fatigue (1849); Fever (1858); Bone Fracture(s) (1870); Hemoptysis (1887); High Blood Pressure/ Hypertension (1908); Inflammation (1932); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Pneumonia (2011); Scarring (2061); Seroma (2069); Swelling (2091); Tachycardia (2095); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Tingling (2171); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Injury (2348); Malaise (2359); Depression (2361); Numbness (2415); Neck Pain (2433); Neck Stiffness (2434); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Hematuria (2558); Dysuria (2684)
Event Type  Injury  
Event Description
It was reported that the patient underwent a posterior lumbar interbody fusion at l4-s1 using a spinewave staxx xd fusion cage and rhbmp-2/acs.This cage was placed into the disc space along with the bmp2.The bmp was also placed in the posterolateral aspects of the spine, bilaterally.Sometime postop, the patient reportedly developed radiating pain in his legs, as well as experiencing ectopic bone growth, inflammatory reaction, non-union, neuro deficit, nerve injury, neurological injury, and pain.
 
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
It was reported that on (b)(6) 2012: patient presented with back pain due to fall.X-ray of lumbar spine.Impression: anterior and posterior fusion at l4-5 and l5-s1.Hardware appears intact.Alignment was unchanged.No evidence of acute injury.(b)(6) 2012: patient underwent x-ray of the chest.Impression: right base consolidation, likely pneumonia.(b)(6) 2012: patient underwent x-ray of the lumbar spine.Comment: there was fusion of l4, l5, and s1.Patient presented with low back pain.Patient underwent x-ray of the chest.Impression: no acute abnormality.(b)(6) 2012: patient presented with local pain over the posterior neck and c-spine, no acute injury.(b)(6) 2013: patient underwent complete abdominal sonogram.Impression: small simple bilateral renal cysts.(b)(6) 2013: patient underwent ct lumbar spine post myelogram with sagittal and coronal reformed images.Impression: 1.Completed fusion l4-s1.2.Minor disc bulge with mild facet osteoarthritis l3-l4.There is mild central stenosis.3.The remainder of the study is within normal limits.(b)(6) 2013: patient underwent x-ray of the chest.Impression: bibasilar atelectasis/ scarring.Patient presented with back pain.(b)(6) 2013: patient presented with back pain.(b)(6) 2013: patient underwent x-ray of the left hand.Comment: there was a dorsal soft tissue swelling.There was linear lucency in the cortex of the dorsal proximal surface of one of the metacarpals, probably the third.(b)(6) 2013: patient presented with soft tissue injury to dorsum of left hand.(b)(6) 2014: patient underwent x-ray of the left hand.Comment: there was a dorsal soft tissue swelling.There was linear lucency in the cortex of the dorsal proximal surface of one of the metacarpals, which may represent a nondisplaced fracture.(b)(6) 2014: patient underwent ct of the spine cervical.Impression: no acute abnormality.Patient underwent ct of the head w/o contrast.Impression: normal.Patient presented with back pain and neck pain.(b)(6) 2014: patient presented with back pain and bilateral leg pain.Patient underwent x-ray of the spine.Impression: intact fusion.No significant degenerative changes at the unfused levels.No acute abnormality or evidence of neoplasm.(b)(6) 2014 patient underwent ct of the lumbar spine without contrast.Impression: 1.Status post l4-5 posterior fusion.2.Minimal chronic anterior wedging of t12 and l1.3.Mild l3-4 is generalized disk bulging.(b)(6) 2014: patient underwent x-ray of the left hand.Impression: left second metacarpal fracture.(b)(6) 2014: patient presented with pain with joint movement affecting the dorsum of the left hand.(b)(6) 2014: patient presented with hand pain, chronic obstructive pulmonary disease, hypertension.(b)(6) 2014: patient presented with flank pain - right side chronic.Ct scan of the abdomen and pelvis with contrast impression: 1.Focal circumferential wall thickening of the sigmoid colon may be artifactual and related to incomplete distension or a focal peristalsis.Neoplasm cannot be excluded.Colonoscopy is recommended if not recently performed.2.Otherwise, no acute abdominal abnormality identified.3.Hepatic steatosis versus artifact from incomplete distension.(b)(6) 2014: patient presented with back pain, poss infection to right lower back form a nail prick.(b)(6) 2014: patient presented with lower back and right knee pain.T-spine wedge compression, lspine, l-spine canal stenosis, lumbago, l-spine bulging disc, failed laminectomy syndrome/failed back surgery, lumbar radiculopathy, l-spine spondylosis, muscle pain, muscle spasm (b)(6) 2014: patient underwent ct scan of spine.Impression: 1.Postsurgical changes at the l4-6 and l5-s1 levels as described above.There do appear to be residual bilateral foraminal spinal stenoses at both of these levels secondary to posterior osteophytes and to facet arthrepathy.2.Posterior disc bulge at the l3-4 level with stable bilateral foraminal spinal stenosis.(b)(6) 2014: patient presented with back pain.(b)(6) 2015: patient presented with chest pain.Pa and lateral chest xray impression: suboptimal pacification of the central pulmonary arteries, but no gross pulmonary embolus.Probable multifocal pneumonia in the right upper lobe and partial atelectasis of the left upper lobe.Assessment: right upper lobe multifocal pneumonia2.Hemoptysis 3.Gpc in 1/2 blood cultures 4.Hypertension/hyperlipidemia/gerd 5.Anxiety/depression 6.Bph 7.Chronic back pain.8.Chronic smoking (b)(6) 2015: digital pa and lateral chest: impression: the previous very vague consolidation in the right upper lobe and the collapse along the left major fissure is no longer apparent but there is a new very vague area consolidation in the right lung base believe in the right middle lobe (b)(6) 2015: the patient presented with knee pain.The patient underwent x-ray of right knee 3 views.Impression: postsurgical changes, no acute osseous abnormality are identified.(b)(6) 2015: patient underwent mri cervical spine wo contrast.Impression: exam limited by motion.C5-6: minimal broad-based disc osteophyte complex.Canal patent.No cord compression.Moderate bilateral neuroforaminal narrowing, secondary to uncovertebral hypertrophy.C6-7: mild broad-based disc osteophyte complex.Canal patent.Moderate bilateral neuroforaminal narrowing, secondary to uncovertebral hypertrophy.C4-5: minimal broad-based disc osteophyte complex.Canal patent.Right foramen patent.Left uncovertebral hypertrophy, causing moderate left neuroforaminal narrowing.No cord compression.Mild multilevel facet degenerative changes.(b)(6) 2015: patient presented with extremity weakness.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2005: the patient presented with right leg pain.On (b)(6) 2005: the patient presented with back and leg pain.On (b)(6) 2006: the patient presented with chest pain.On (b)(6) 2006, (b)(6) 2007: the patient presented with toothache.On (b)(6) 2006: the patient presented with neck pain.On (b)(6) 2007: the patient presented with right knee pain.On (b)(6) 2007: the patient presented with kidney pain.On (b)(6) 2008: the patient presented with sore throat.On (b)(6) 2011: the patient presented for follow-up of slip and fall.On (b)(6) 2011: the patient presented with abdominal pain.On (b)(6) 2011: the patient presented with pain in right side and refill of medications.On (b)(6) 2011: the patient presented for hardware removal, right patella.On (b)(6) 2011, (b)(6) 2012: the patient presented for follow-up.On (b)(6) 2012: the patient presented with the problem of coughing up blood.On (b)(6) 2012: the patient presented with degenerative disk disease and numbness in left arm.On (b)(6) 2012: the patient presented with congestion, runny nose and constipation.On (b)(6) 2012: the patient presented with lower back pain.On (b)(6) 2012: the patient presented with hypertension and degenerative disk disease.On (b)(6) 2012: the patient presented with syncope.On (b)(6) 2012: the patient underwent echocardiogram and cartoid duplex study.On (b)(6) 2012: the patient presented with neck pain.On (b)(6) 2012: the patient presented with fever and urinary renal infection symptoms.On (b)(6) 2013: the patient presented for follow-up of slip and fall.On (b)(6) 2013: the patient presented with the problems of blood in urine and back pain.On (b)(6) 2013: the patient presented with blurry vision and head pain.11/26/2013: the patient underwent ct of cervical spine.On (b)(6) 2014: the patient presented with chronic back pain and neck pain.On (b)(6) 2014: the patient presented to pain management due to pain.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Current: age: (b)(6); height: (b)(6); weight: (b)(6).It was reported that prior to his surgery with rhbmp-2/acs he had a little back pain that was managed through medication.Reportedly,the patient had extreme back pain, back worn out.These conditions led to rhbmp-2/acs surgery.On an unknown date in 2005, the patient presented for an office visit.On an unknown date in 2010, the patient was diagnosed with back pain.On (b)(6) 2010, the patient presented with diagnosis of degenerative disk disease, lower back pain.On (b)(6) 2011, the patient presented for right patella hardware removal.From 2011 to 2013, the patient presented with diagnosis of lower back pain.On an unknown date in 2012, the patient presented for follow up care post lumbar fusion and back pain.From 2012 to present day, the patient presented with diagnosis of lower back pain, complications and pain post lumbar fusion from 2012 to 2013, the patient presented with diagnosis of lower back pain, urinary complications and weakness.On (b)(6) 2012, the patient underwent rhbmp-2/acs surgery and was also implanted with synthes matric system, pedicle screw system.Cobalt chromium rods at l4-l5.Mtf dbx mix.Staxx xd cartridge (4).Autograft, morselized allograft.On (b)(6) 2012, the patient presented for an office visit.On (b)(6) 2013, the patient was diagnosed with back pain.On (b)(6) 2013, the patient presented with diagnosis of back pain.On (b)(6) 2013, the patient presented with diagnosis of pain.On an unknown date in 2014, the patient presented with diagnosis of chronic lower back pain, neck pain.Post-op, his back pain and other symptoms began to increase.The pain started radiating down his legs.The pain was unbearable and was constant and it got worse every day.Currently, he continues to experience extreme back pain.He was extremely depressed and have suicidal thoughts.He is no longer phys ically able to participate in : daily walking, home repairs, normal daily activities, sexual functions.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 2012: patient underwent x-ray of the chest.Impression: small left pleural effusion.Atelectasis was also possible.On (b)(6) 2012: patient underwent x-ray of the lumbar spine.Impression: postoperative changes at l4-5 and l5-s1.No fracture of the hardware was seen.Alignment was unchanged.On (b)(6) 2012 and (b)(6) 2012: patient presented with cervical radiculitis, degenerative disc disease.On (b)(6) 2012: patient underwent x-ray of the cervical spine.Impression: moderate degenerative disc disease at c6-c7.Mild degenerative disc disease and mild bilateral neural foraminal stenosis at c5-c6.On (b)(6) 2012: patient underwent mri of the cervical spine.Impression: mild cervical spondylosis which was mostly protruded disc most prominently on the right side at c5-6 where there was mild nerve root sleeve distortion.On (b)(6) 2012: patient presented with mood swings, anxiety.On (b)(6) 2012: patient underwent x-ray of the lumbar spine.Impression: no internal change.On (b)(6) 2012, (b)(6) 2012 and (b)(6) 2012: patient presented for follow up lumbar pain and bilateral lower extremity pain right greater than left follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody/posterolateral fusion.Musculoskeletal: the patient reports chronic low back pain, bilateral lower extremity pain and fibromyalgia.Lumbosacral spondylosis l5-s1, operated.Lumbar radiculopathy/right, right si, improved post op.Lumbar hnp/right, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.Drug withdrawal, opiate withdraws.Noncompliance.On (b)(6) 2012: patient underwent mri of neck which shows degenerative changes not too severe.On (b)(6) 2012: patient underwent mri of the lumbar spine.Impression: anterior and posterior fusion at l4-l5 and l5-s1.Spinal canal widely patent at these levels.Foraminal stenosis was seen bilaterally at l5-s1.This was unchanged.Small fluid collection in the laminotomy site at l4-l5 extending to the l5 level posterior to the thecal sac.Suspect a small benign seroma with pseudomeningocele felt less likely.Abscess was felt unlikely and clinical correlations recommended.No spinal stenosis seen and no nerve root compression were demonstrated.On (b)(6) 2012: patient underwent mri which reveals degenerative neck changes.On (b)(6) 2012: patient presented with pneumonia, degenerative disc disease.On (b)(6) 2012: patient underwent x-ray of the chest.Impression: interval resolution right lower lobe pneumonia.As per examination, there was no evidence of interbody graft fragmentation.There was no hardware failure.On (b)(6) 2012: patient underwent x-ray of the lumbar spine.Comment: there was fusion of l4, l5, and s1.On (b)(6) 2012: patient presented with syncope.On (b)(6) 2012: patient presented with right arm hurting and swelling after falling, confusion of arm, degenerative disc disease.Patient underwent x-ray of the lumbar spine.Comment: there was fusion of l4, l5, and s1 using transpedicle screws and interbody devices.Patient had had laminectomy at l5.Patient underwent x-ray of the right forearm which shows no fracture.On (b)(6) 2012: patient underwent x-ray of the arm.Impression: normal.On (b)(6) 2012: patient presented with burning while urinating, diarrhea, acute sinusitis, dysuria.On (b)(6) 2012: patient presented with chronic nonspecific lung disease, fatigue and malaise, abdominal pain, left lower quadrant, tachycardia.On (b)(6) 2013: patient presented with swollen testicle.On (b)(6) 2013: patient presented with having skin tag removed from right eye.On (b)(6) 2013: as per telephonic conversation, patient reported numbness from his waist down including his private and legs in pain.On (b)(6) 2013: patient presented with abscess of buttock, tachycardia, hematochezia.As per the message, patient was having stomach pain.On (b)(6) 2013: patient presented with blood in urine, pain in back, diaphoresis, hematuria.On (b)(6) 2013: patient was diagnosed with abdominal pain left lower quadrant, degenerative disc disease.On (b)(6) 2013: patient presented with back pain, sharper pain down the right leg.Assessment: dysuria, degenerative disc disease, sprain of back.On (b)(6) 2013: patient underwent mri of the lumbar spine.Impression: stir hyperintensity in the right side of l4 and l5 vertebral bodies could be related to trauma.Right s1 screw probably contacts the exiting l5 nerve root in the neural foramen, but this could be artifactual.Postsurgical changes from l4 to s1 and posterior paraspinous soft tissue stir hyperintensity.On (b)(6) 2013: patient presented with testicular swelling, pain.Assessment: degenerative disc disease, chronic nonspecific lung disease.On (b)(6) 2013 and (b)(6) 2013: patient underwent ct scan of brain.Impression: stable white matter disease.No acute intracranial abnormality.Chronic ethmoid sinus disease.On (b)(6) 2013: patient presented with soft tissue injury to dorsal aspect of left forearm.Musculoskeletal: the patient had mild to moderate joint pain with movement of the dorsum of the left hand.Moderately tender to palpation over the dorsum of the left hand.Exam over the dorsum of the left hand demonstrates a mild to moderate amount of swelling no palpable effusion over the dorsum of the left hand.The area over the dorsum of the left hand was consistent with a mild to moderate contusion.Patient underwent x-ray of left hand.Impression: dorsal, soft tissue swelling with no underlying osseous abnormality identified.On (b)(6) 2013: patient presented with lumbar back pain, lumbar degenerative disc disease.Musculoskeletal: present- low back pain, joint pain, neck pain, joint swelling and neck stiffness.Not present- calf pain, fibromyalgia, decreased range of motion, middle back pain, muscle tenderness, neck mass, muscle cramps and muscle weakness.On (b)(6) 2013: patient presented with chest congestion and trouble coughing up yellow phlegm.On (b)(6) 2013: patient underwent lumbar myelogram.Impression: mild spinal stenosis l3-l4 in the upright position.Lumbar fusion from l4-s1.Patient underwent ct of lumbar spine post myelogram with sagittal and coronal reformed images.Impression: completed fusion.Minor disc bulge with mild facet osteoarthritis l3-l4.There was mild central stenosis.On (b)(6) 2013: patient presented with low back pain due to exacerbation of a chronic low back injury radiating to foot, tingling, and numbness.On (b)(6) 2013: patient presented for injury to posterior neck and c-spine.Cervical (neck) strain injury of neck, chronic back pain.Patient underwent x-ray of the cervical spine.Impression: degenerative spondylosis most pronounced at c6-7.Impression: degenerative spondylosis most pronounced at c6-7.On (b)(6) 2013: patient presented with degenerative disc disease.On (b)(6) 2013: patient underwent x-ray of the chest.Impression: bibasilar atelectasis/ scarring.On (b)(6) 2013: patient presented with contusion of left hand.Conclusion: dorsal soft tissue swelling, nondisplaced fracture.On (b)(6) 2014: patient underwent x-ray of the hand bones.On (b)(6) 2014: patient underwent ct of the spine cervical.Impression: no acute abnormality.Patient underwent ct of the head w/o contrast.Impression: normal.On (b)(6) 2014: patient underwent scan of the lumbar spine without contrast revealing status post l4-l5 posterior fusion.Minimal chronic anterior wedging of t12 and l1.Mild l3-l4 generalized disk bulging.On (b)(6) 2014: patient presented for follow-up of lumbar pain and right lower extremity pain.Musculoskeletal: the patient reports chronic low back pain, bilateral lower extremity pain and fibromyalgia.Lumbar spondylolisthesis (minimal retrolisthesis) l1 on l2.Lumbar degenerative disc disease, throughout the lumbar spine, previous plif l4-l5, l5-51.Lumbosacral spondylosis, mild l3-l4.Low back pain.Sacroiliitis /right.Leg pain /right.On (b)(6) 2012: patient underwent x-ray of the chest.Impression: small left pleural effusion.Minimal pneumonia or atelectasis was also possible.On (b)(6) 2012 the patient came for follow-up of lumbar pain and bilateral lower extremity pain right greater than left and follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody-posterolateral fusion.Patient complains of severe lumbar and right lower extremity pain.He describes leg pain as exactly the same as before undergoing posterior lumbar interbody fusion.He was nauseated, diaphoretic and very irritable.He was exhibiting classic symptoms of withdraw.The patient was diagnosed for: lumbosacral spondylosis l5-s1, operated.Lumbar radiculopathy, right 51, improved post op.Lumbar hnp, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.On (b)(6) 2012: the patient presented with pain in legs.On (b)(6) 2012, (b)(6) 2012 the patient came for follow-up of lumbar pain and bilateral lower extremity pain right greater than left and follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody-posterolateral fusion.Patient complains of severe lumbar and right lower extremity pain.The patient was diagnosed for: lumbosacral spondylosis l5-s1, operated.Lumbar radiculopathy, right 51, improved post op.Lumbar hnp, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.On (b)(6) 2012, (b)(6) 2012 the patient came for follow-up of lumbar pain and bilateral lower extremity pain right greater than left and follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody-posterolateral fusion.Patient complains of severe lumbar and right lower extremity pain.Musculoskeletal examination: gait: gait was non-antalgic.The patient was diagnosed for: lumbosacral spondylosis l5-s1, operated.Lumbar radiculopathy, right 51, improved post op.Lumbar hnp, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.On (b)(6) 2012: the patient presented with local pain over the low back.On (b)(6) 2012: the patient came for an office visit and was diagnosed for noncompliance, drug withdrawal, lumbar radiculopathy r, lumbar hnp r, lumbosacral spondylosis, lbp, ddd.On (b)(6) 2012: the patient underwent mri of cervical spine.Impression: mild cervical spondylosis which was mostly protruded disc most prominently on the right side at c5-6 where there was mild nerve root sleeve distortion.On (b)(6) 2012: the patient came for a follow-up of lumbar pain and bilateral lower extremity pain right greater than left and follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody-posterolateral fusion and a post-op exam.The patient reports increased lumbar pain after a ground-level fall.Musculoskeletal examination: gait was non-antalgic.The patient was diagnosed for: lumbosacral spondylosis, l5-s1, operated.Lumbar radiculopathy, right s1, improved post op.Lumbar hnp, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.Drug withdrawal, opiate.Noncompliance, patient was not compliant with smoking cessation or prescribed usage.On (b)(6) 2012: the patient underwent x-ray of thoracic spine due to pain and trauma.Impression: no acute findings in the thoracic spine.On (b)(6) 2012: the patient underwent x-ray of thoracic spine due to pain and trauma.Impression: prior posterior lumbar interbody fusion at l4-s1 without complicating features.Minimal likely degenerative retrolisthesis at l4-5.On (b)(6) 2012: the patient underwent ct of lumbar spine w/o contrast due to back pain, leg pain.Impression: prior surgery.No acute fracture.Limited examination due extensive streak artifact.Diffuse disc bulge at the l3-l4 level, on (b)(6) 2014: the patient presented with the following admitting diagnosis: low back pain in a patient with history of l4-l5, l5-s1 plif (b)(6) 2012.History of hypertension.History of hyperlipidemia.History of gastroesophageal reflux disease.History of chronic obstructive pulmonary disease.History of depression and anxiety with episodes of psychosis.Tobacco use.Musculoskeletal ros: reports right lower back pain and right lower extremity pain.Impression: right sacroiliitis.On (b)(6) 2014: the patient underwent x-ray of right knee due to back and leg pain.Impression: prior patellar surgery.Osseous fragments along the patella likely to the prior fractures.No definite acute fracture seen.On (b)(6) 2012: the patient x-ray of lumbar spine.Impression: status post anterior and bilateral posterolateral spinal fusion at l4-5 and l5-s1.Slight dextroscoliosis.On (b)(6) 2012: the patient came for a follow-up of lumbar pain and bilateral lower extremity pain right greater than left and follow-up of l4-5, l5-s1 lumbar plif with decompression and interbody-posterolateral fusion and a post-op exam.The patient reports increased lumbar pain after a ground-level fall.Musculoskeletal examination: gait: antalgic to the right and ambulates with assistance of a cane.Inspection and palpation: examination of the right lower extremity revealed ace bandage to right knee with erythema and ecchymosis.The patient was diagnosed for: lumbosacral spondylosis, l5-s1, operated.Lumbar radiculopathy, right s1, improved post op.Lumbar hnp, right l5-s1, operated.Low back pain, chronic.Lumbar degenerative disc disease.Drug withdrawal, opiate.Noncompliance, patient was not compliant with smoking cessation or prescribed usage.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that on (b)(6) 2015: patient presented with hemoptysis <(>&<)> chest pain and stayed in hospital for these days.The patient underwent leg bilateral venous.Impression: within normal limits.The patient was discharged from the hospital on (b)(6) 2015.The patient also underwent a 2 dimension transthoracic echocardiogram.Summary: no significant valvular abnormalities.The right ventricle is normal in size and function.There is no pericardial effusion.On (b)(6) 2015: the patient underwent x-ray of chest anteroposterior due to pneumonia.Impression: near complete interval clearing of the lung.On (b)(6) 2015: the patient presented with a chief complaint of pneumonia with chronic airway obstruction, shortness of breath and chest pain.On (b)(6) 2015: the patient presented with an injury in neck and head due to motor vehicle accident.On (b)(6) 2015: patient presented with extremity weakness.The patient also underwent ct of head without contrast due to dizziness.Impression: age-related atrophy and mild to moderate ischemic small vessel disease.No apparent acute abnormality.The patient underwent x-ray of chest.Impression: mild basilar interstitial disease.On (b)(6) 2015: the patient underwent electrocardiogram.Impression: normal ecg.On (b)(6) 2015: the patient presented with complaint of fever accompanied with generalized body aches, dyspnea, fatigue and prod cough with yellow sputum.The patient underwent x-ray of chest due to dyspnea and cough.Impression: essentially stable exam with no acute findings.On (b)(6) 2015: the patient presented with complaint of cough.The patient underwent x-ray of chest 2 view.Impression: no acute chest process identified; stable mild atelectasis/scarring involving the left lung base.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3898190
MDR Text Key4546498
Report Number1030489-2014-02945
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup,Followup
Report Date 04/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/06/2015
Initial Date FDA Received06/26/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received08/04/2015
11/10/2015
05/09/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight91
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