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U.S. Department of Health and Human Services

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

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Bronchitis (1752); Dyspnea (1816); Pulmonary Emphysema (1832); Fever (1858); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Swelling (2091); Burning Sensation (2146); Chills (2191); Cramp(s) (2193); Chronic Obstructive Pulmonary Disease (COPD) (2237); Depression (2361); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Event Description
It was reported that the patient underwent a tlif at l5-s1 using an interbody cage packed with rhbmp-2/acs.A posterolateral fusion was also performed at the same level with rhbmp-2/acs.Following surgery, patient followed up with his physician.He began to develop radiating pain in his legs and feet.Patient has never recovered from his surgery, and continues to experience daily, disabling pain that prevents him from performing many basic activities of daily living.
 
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.
 
Manufacturer Narrative
Additional information: (b)(6) (b)(4).
 
Event Description
It was reported that on (b)(6) 2007: the patient presented with aggravation of pain with shooting pains down the neck and both arms.(b)(6) 2007: the patient underwent left cervical facet joint injection with local anesthetic and steroid under fluoroscopic guidance (facet joints ofc4-c5, c5-c6, and c6-c7) (b)(6) 2007: the patient underwent cervical epidural steroid injection.(b)(6) 2007: the patient underwent procedure #1: magnetic resonance imaging, spinal canal and contents, lumbar; without contrast.Procedure #2: magnetic resonance imaging, spinal canal and contents, sacrum; without contrast.Impression: grade 1-2 anterolisthesis of ls on 81, with bilateral ls spondylolysis.There is severe bilateral foraminal narrowing.(b)(6) 2007: the patient underwent lumbar epidural steroid injection.(b)(6) 2007, (b)(6) 2006: the patient presented for a follow up of aggravation of pain.(b)(6) 2008, (b)(6) 2007: the patient underwent lumbar epidurogram.(b)(6) 2007: the patient presented with low back pain.(b)(6) 2009: the patient has ongoing pain with shooting pain down lower extremities.(b)(6) 2010: the patient presented with an area of draining in the back.(b)(6) 2010: patient presented with the following assessment: low back pain, lower extremity radiculitis, lumbar degenerative disc disease at l2-3 level with bulge at l5-s1 level.Status post back surgery.Postlaminectomy syndrome with scaring.Radiculitis, neuropathy, intermittent exacerbation of pain, neuropathic pains.(b)(6) 2010, (b)(6) 2009, (b)(6) 2008: the patient presented with periods of aggravation of pain.
 
Event Description
It was reported that on: (b)(6) 2010: patient presented for office visit.On (b)(6) 2010: ultrasound of the low back area around l5 in the midline shows a hypo echoic collection that measures 2 cm in depth and 1 cm in transverse plane in each dimension.This may represent fluid from the sinus tract communicating with the previous surgical site.On (b)(6) 2010: patient admitted to hospital with diagnosis of malfunction of vascular device/graft and underwent removal fb/dev from skin (picc line pulled out partially).On (b)(6) 2011: patient presented with major problem of chronic back pain, hypertension, anxiety, copd.On (b)(6) 2011: patient presented with major problem of tobacco use disorder.On (b)(6) 2013: the patient presented with admit diagnosis of abdominal pain and principal diagnosis of calculus of ureter.On (b)(6) 2014: patient presented with principal diagnosis of lumbago and secondary diagnosis of hypertension (b)(6) 2014: patient presented with principal diagnosis of lumbago and hypertension.On (b)(6) 2014: patient presented with admit diagnosis of b-complex deficiency.On (b)(6) 2014: patient presented with admit diagnosis of lumbago and secondary diagnosis of b-complex deficiency and hypertension.On (b)(6) 2014: patient presented with admit diagnosis of abnormal glucose nec and secondary diagnosis of lumbago, b-complex deficiency.On (b)(6) 2014: following pre-op problems were noted: copd, smoker, hypertension, back pain.As per endoscopy nursing care record: redness noted to bilateral buttocks prior to the procedure.On (b)(6) 2014: patient presented for admitting diagnosis of "special screening of neoplasm-colon" and secondary diagnosis of obesity, benign neoplasm of colon and underwent following procedure: polypectomy of rectum.On (b)(6) 2014: patient presented with diagnosis of bronchitis and tobacco use disorder.On (b)(6) 2015: the patient presented with shoulder pain.On (b)(6) 2015: patient presented with principal diagnosis of hypertension and secondary diagnosis of lumbago, allergic rhinitis.On (b)(6) 2015: patient presented for consultation of lesion left forearm.Patient states that lesion is sore but not painful and bleeds sometimes.Assessment: squamous cell carcinoma of skin, left forearm.On (b)(6) 2015: patient presented for office visit.On (b)(6) 2015: patient presented with pre-operative diagnosis of posterior left arm fungating lesion with secondary diagnosis of squamous cell carcinoma of skin of upper limb, hypertension, anxiety and underwent procedures: removal of skin lesion, repair of wounds.No patient complications.Patient underwent pathology examination with clinical diagnosis of left forearm lesion.Specimen: left forearm lesion, short is superior and long is lateral.On (b)(6) 2015: patient presented for office visit.
 
Event Description
It was reported that the patient presented with chief complaint of low back and leg pain.The patient underwent examination.Impression: l5 spondylolysis; l5-s1 spondylolisthesis and foraminal stenosis; chronic low back pain and left sciatica.The patient underwent ct lumbar spine.Impression: bilateral pars defects at l5-s1 with associated anterior spondylolisthesis; degenerative disc disease at l5-s1; moderately severe bilateral neural foraminal narrowing at l5-s1.On (b)(6) 2009: the patient presented with lower back pain.On (b)(6) 2009: the patient underwent xr spine lumbar lateral portable.On (b)(6) 2009: the patient presented with back pain in lumbar.On (b)(6) 2010: the patient presented with back pain and numbness in left leg and foot.On (b)(6) 2010: the patient presented with drainage from lumbar area in the back.Impression: ongoing drainage from an epithelialized sinus tract in the lower lumbosacral region; status post l4-s1 posterior fusion in (b)(6) 2009.There is no evidence of spine infection; chronic mechanical low back pain syndrome, lumbar spondylosis and pain.The patient had lower back pain.On (b)(6) 2009: the patient presented with chief complaint of low back and leg pain.The patient underwent examination.Impression: l5 spondylolysis; l5-s1 spondylolisthesis and foraminal stenosis; chronic low back pain and left sciatica.The patient underwent ct lumbar spine.Impression: bilateral pars defects at l5-s1 with associated anterior spondylolisthesis; degenerative disc disease at l5-s1; moderately severe bilateral neural foraminal narrowing at l5-s1.On (b)(6) 2009: the patient presented with lower back pain.On (b)(6) 2009: the patient underwent xr spine lumbar lateral portable.On (b)(6) 2009: the patient presented with back pain in lumbar.On (b)(6) 2010: the patient presented with back pain and numbness in left leg and foot.On (b)(6) 2001 the patient presented with preoperative diagnosis of gunshot wound to the abdomen and postoperative diagnosis of gunshot wound to the abdomen with multiple perforations to the terminal ileum, ileum and perforation to the cecum and right colon.The patient underwent the following procedure: exploratory laparotomy with two areas of small bowel resection in addition to small bowel repair and partial resection of the right colon with an ileocolostomy anastomosis.The patient underwent ct scan of abdomen with contrast.Impression: there appeared to be some blood in the lower posterior pelvis.The patient underwent x-rays of chest.Impression: there appeared to be small infiltrated in the bases.On (b)(6) 2001 the patient admitted to hospital with preoperative diagnosis of: chronic refractory lower back pain; left sacroiliac joint dysfunction.On (b)(6) 2001, (b)(6) 2002 the patient underwent the following procedure: left sacroiliac joint injection with local anesthetic and steroid.On (b)(6) 2002 the patient admitted to hospital with preoperative diagnosis of: chronic refractory lower back pain; left sacroiliac joint dysfunction; left lumbar facet syndrome.The patient underwent the following procedure: left sacroiliac joint injection with local anesthetic and steroid; left lumbar facet joint injection with local anesthetic and steroid( facet joints of l2-l3, l3-l4, l4-l5 and l5-s1.On (b)(6) 2002 the patient underwent ultrasound of the bilateral renals.On (b)(6) 2003 the patient underwent nm myocardial perfus w/wall motion procedure.On (b)(6) 2005 the patient underwent sleep study due to sleep apnea.Impressions: severe obstructive sleep apnea.On (b)(6) 2006 the patient underwent: uvulopalatopharyngoplasty; tonsillectomy; septoplasty; bilateral inferior turbinate submucous resection; radiofrequency thermoblation of base of tongue.Preoperative diagnosis: obstructive sleep apnea; nasal septal deviation; bilateral inferior turbinate hypertrophy; macroglossia.Impressions: status post obstructive sleep apnea procedures with expected postoperative pain.On (b)(6) 2006 the patient presented with chief complaint of "nerve".The patient underwent x-rays of chest.Impression: normal chest (b)(6) 2006 the patient presented for an office visit due to itch.On (b)(6) 2007 the patient presented for follow up of his blood pressure and for refills on his zestril.On (b)(6) 2007 the patient presented for an office visit for refill on his klonopin and for blood work.On (b)(6) 2007 the patient underwent stress echocardiogram.On (b)(6) 2008 the patient presented for follow up on his blood pressure and medication refills.On (b)(6) 2009 the patient presented for an office visit with chief lumbar stenosis.On (b)(6) 2009 the patient presented for an office visit with chief complaint of spinal lumbar fusion.On (b)(6) 2010 the patient presented with osteomyelitis, infected hardware lumbar spine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, on (b)(6) 2008 patient presented with low back pain in lumbar and lumbo-sacral region.On (b)(6) 2009: patient underwent x-ray lumbar spine, three views.Impression: mild anteriolisthesis of l5 on s1 (b)(6) 2009: patient presented with low back pain.On (b)(6) 2010; (b)(6) 2009 patient presented with low back pain and left leg numbness.On (b)(6) 20010: the patient presented for lower back pain and underwent x-ray lumbar spine, three views.Impression: the posterior fusion of l4 through s1 appears intact.There is mild compression of the l5 vertebral body posteriorly.No other remarkable findings.On (b)(6) 2010: the patient presented for postoperative follow-up and complained of continued back and left leg pain.Some drainage had developed inferior to incision.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2007: the patient presented with back and neck pain.The patient underwent mri of cervical spine due to neck pain.Impression: degenerative disk disease with small left posterior paracentral herniation at the c5-c6 level.On (b)(6) 2007: the patient presented with dyspnea and shortness of breath.He underwent x-rays of the chest due to cough.Impression: no active disease.He also underwent 3 views of sinuses due to chronic bronchitis.Impression: sinusitis involving the frontal and maxillary sinuses.On (b)(6) 2007: the patient ct scan of the chest due to shortness of breath.Impression: there is no fibrotic change noted in the left base with pleural reaction.On (b)(6) 2007: the patient presented for follow-up with severe emphysema.Cat scan of the chest was reviewed which revealed emphysema.He was still having significant problem with cough, congestion, and sputum production although he said that he has quit smoking but still his dyspnea was significant.On (b)(6) 2007: the patient presented for a pre-op for bronch.He had a history of coal workers pneumoconiosis stage 0, significant cough, congestion, sputum production, and dyspnea.On (b)(6) 2007: the patient presented for follow-up.He had some blood tinged sputum with severe cough.On (b)(6) 2007: the patient presented pre-op with recurrent bronchitis, homoeopathists, coal workers' pneumoconiosis, history of tobacco abuse.On (b)(6) 2007: the patient presented with the following pre-operative diagnoses: chronic bronchitis.Chronic dyspnea.Hemoptysis.Coal worker's pneumoconiosis.Tobacco abuse.Left lower lobe atelectasis.He underwent pulmonology/ccm.He had the following postoperative findings: thick mucus plug in the left lower lobe; generalized deposition of anthracosilicosis; no obvious endobronchial tumors seen; vocal cords appear normal.Detailed bl and brushings were done from the left lower lobe.There were no patient complications.The patient underwent x-ray fluoroscopy for performing bronchoscopy.On (b)(6) 2007: the patient presented with pneumoconiosis, chronic bronchitis and tobacco abuse.On (b)(6) 2008: the patient presented follow-up with a history of underlying copd, chronic bronchitis, tobacco abuse.He also had sleep apnea.On (b)(6) 2009: the patient presented for a follow-up with guaiac positive stools.He had a history of emphysema, chronic bronchitis, and heavy tobacco abuse.On (b)(6) 2009: the patient presented with low back pain and leg pain.Ct scan of the lumbar spine was reviewed which showed spondylolysis at l5; grade i spondylolisthesis at l5-s1; a vacuum disc phenomenon at l5-s1.Mri was also reviewed that showed some desiccation at l4-5 and severe degeneration of the disc at l5-s1 with modic changes.On (b)(6) 2009: the patient presented with the following diagnoses: chronic obstructive pulmonary disease, low back pain and high blood pressure.He underwent x-rays of the chest due to hypertension.Impression: atelectasis.On (b)(6) 2009: the patient presented with the following preoperative diagnoses: gastroesophageal reflux disease.Question hiatus hernia.Question duodenal ulcer.Question gastric ulcer.Question gastritis.Question gbr.Family history of colon cancer.He underwent the following procedures: video esophagogastroduodenoscopy; clotest; biopsy of the antrum of the stomach; esophageal biopsy was not attempted since the distal esophagus appeared rather friable.The patient underwent colonoscopy with sigmoid polypectomies piecemeal style on 3 small colon polyps, all within 5 to 8 cm of one another in the mid sigmoid area, approximately 20 to 25 cm from the anus.No patient complications were reported.On (b)(6) 2009: the patient underwent video esophagogastroduodenoscopy.On (b)(6) 2009: the patient presented with intractable leg pain and was admitted.He had the following pre-operative diagnoses: l5 spina bifida.L5 bilateral spondylolysis.L5-s1 spondylolisthesis and spinal stenosis.He underwent the following procedures: l5-s1 smith-petersen osteotomy.Left l5-s1 transforaminal interbody fusion with a 10 x 22 mm cage, rhbmp-2/acs and morselized bone graft.L4-s1 segmental posterolateral fusion with tsrh 3-d pedicle screw fixation and morselized bone graft and rhbmp-2/acs.Computerized assisted surgical navigation for pedicle screw placement.Local bone autograft harvesting.Single incision posterior 360 degree lumbar fusion.Per op notes, smith-peterson osteotomy was performed at l5-s1, which included total laminectomy at l5, partial laminectomy at s1 and total facetectomies at l5-s1.The bone dust from the drilling was collected in a lukens trap and was mixed with ceramic bone graft extender to form the morselized bone graft.The transverse processes and ala of the sacrum were decorticated with the drill.Strips of rhbmp-2/acs were layered with morselized bone graft on both sides.Then the pedicle screws were placed.The pedicle screws at l5 and s1 on both sides were used to distract the disc space.Then the dura was gently retracted towards the midline to expose the left side of the annulus of the l5-s1 disc.Radical discectomy was accomplished.Then morselized bone graft and rhbmp-2/acs were packed in the disc space and pushed to the right side.Then the 10 x 22 mm cage was filled with morselized bone graft sandwiching a small pledget of rhbmp-2/acs.This was then countersunk in the disc space.A 5.5 mm diameter titanium rod was cut and contoured and attached to the pedicle screws with appropriate connectors.The connectors were tightened to breakoff torque on set screws.A crosslink was placed between the l5 and s1 pedicle screws.It was tightened to breakoff torque on set screws.No patient complications were reported.He underwent rf fluoroscopy, intra-op, which was provided for posterior fusion of lower lumbar spine.He also underwent x-ray of the lumbar spine, intra-op, which showed rod and pedicle screw fixation of the l4 to s1 levels; grade 1 anterolisthesis of l5 on s1.On (b)(6) 2009: the patient was discharged.On (b)(6) 2009: the patient presented for initial evaluation of chronic back pain.He continued to report significant severe back pain, numbness in his left lower extremity that was slightly worse since his surgery; it was present before the surgery.Impression: chronic back pain.Gastroesophageal reflux disease.Chronic obstructive pulmonary disease.Anxiety with depression, symptoms not controlled.On (b)(6) 2009: the patient presented for check-up.Impression: anxiety.History of chronic obstructive pulmonary disease.Chronic low back pain.On (b)(6) 2010: the patient underwent x-rays of the chest due to cough.Impression: emphysema, no acute infiltrate.On (b)(6) 2010: the patient presented for medication refill.Impression: chronic obstructive pulmonary disease.Anxiety.Chronic low back pain.On (b)(6) 2010: the patient presented for follow-up on drainage from the lower portion of the lumbar spine wound.Impression: superficial abscess.On (b)(6) 2010: the patient underwent ct of lumbar spine due to open wound of back.Impression: slippage at ls-s1 and hardware placed; severe arthritis at l5-s1; no acute herniation or acute fracture can be detected; moderate degenerative change.On (b)(6) 2010, (b)(6) 2011: the patient presented for follow-up.He reported that his back pain symptoms of severe pain persisted although they increased with activity, bending, twisting.He had stiffness.Pain increased with ambulation.Impression: chronic low back pain.Anxiety stable.Hypertension not controlled.Chronic obstructive pulmonary disease with possible arteriovenous malformation.On (b)(6) 2010: the patient underwent ultrasound of abdomen due to local superficial swelling.Impression: slippage at ls-s1 and hardware placed; severe arthritis at l5-s1; no acute herniation or acute fracture can be detected; moderate degenerative change.On (b)(6) 2010: the patient presented with chronic low back pain.Assessment: history of back surgery in (b)(6) of 2009 now back pain and drainage from the lower aspect of the lumbar spine wound.Copd.Tobacco use.Hypertension.On (b)(6) 2010: the patient underwent x-rays of the chest due to picc placement.Impression: placement of a right-sided picc line whose tip is seen in the superior vena cava.Mass-like density seen in the medial aspect of the left upper thorax that may represent a pulmonary or mediastinal mass.On (b)(6) 2010: the patient presented with low back pain and back drainage.He also had difficulty sleeping due to pain.Impression: status post l4 to s1 posterior fusion in (b)(6) 2009.Recent onset of drainage from a pinhole opening in the lower back.The etiology of this is not clear.Chronic mechanical low back pain syndrome and lumbar spondylosis.He underwent ct of the chest due to abnormal findings.Impression: nodular lobulated area in the left lung base within an area of pericardial fat which could represent an arterial venous malformation of the lungs, accessory draining vein or venous anomaly or venous varices.A couple of other smaller ones can be seen in the anterior mediastinum.They have enhancements and are likely vascular structures.On (b)(6) 2010: the patient underwent x-ray fluoroscopy for less than 1 hour due to osteomyelitis.Impression: successful ultrasound fl uoroscopically guided placement of picc line in the right upper extremity.On (b)(6) 2010: the patient presented for follow-up on drainage from the mid lumbar spine area from the low back.Assessment: history of back surgery back in (b)(6) of 2009.Picc line in the right upper extremity.On (b)(6) 2010: the patient underwent ultrasound of abdomen due to abdominal pain.Impression: fatty liver; no gallstones.On (b)(6) 2010: the patient presented for follow-up on medical problems including a history of possible hardware infection and possible osteomyelitis.On (b)(6) 2010: the patient called and complained of drainage from his back.On (b)(6) 2010: the patient presented with drainage from lumbar area in the back.Impression: ongoing drainage from an epithelialized sinus tract in the lower lumbosacral region.Status post l4-sl posterior fusion in (b)(6) 2009.There is no evidence of spine infection.Chronic mechanical low back pain syndrome, lumbar spondylosis and pain.On (b)(6) 2010: the patient presented with the following preoperative diagnoses: draining sinus tract from the lumbar area.Status post l4-s1 posterior spinal fusion in (b)(6) 2009.He underwent the following procedure: exploration and excision of sinus tract from the lumbar region.No patient complications were reported.On (b)(6) 2010: the patient was discharged.On (b)(6) 2010: the patient presented for a follow-up with significant problems like fever, chills, cough, and shortness of breath.He had history of underlying copd, chronic bronchitis, emphysema and pulmonary nodule.On (b)(6) 2010: the patient underwent x-rays of the chest due to shortness of breath.Impression: no infiltrates are seen; discoid atelectasis in the left base; heart size is in the upper limits of normal; no pleural effusion; interstitial markings noted.On (b)(6) 2010: the patient underwent ct scan of the chest.Impression: no definite evidence of a hilar lymphadenopathy.Soft tissue density is seen in the retrosternal area and also there are multiple rounded densities seen near the left heart boarder and this could represent splenic nodules.No definite evidence of a hilar mass.On (b)(6) 2010: the patient underwent ct scan of the chest.Impression: no definite evidence of a hilar lymphadenopathy.Soft tissue density is seen in the retrosternal area and also there are multiple rounded densities seen near the left heart boarder and this could represent splenic nodules.No definite evidence of a hilar mass.On (b)(6) 2011: the patient presented for follow-up with a history of underlying copd, chronic bronchitis, emphysema and pulmonary nodule.On (b)(6) 2011: the patient presented for follow-up.Impression: hypertension.Hctz was increased to 25b.I.D.Chronic obstructive pulmonary disease stable.Depression stable.Chronic back pain, history of fusion, diskitis.On (b)(6) 2011: the patient presented for follow-up with severe pain in lower lumbar spine.Pain with activity, ambulation, twisting, bending.He had severe pain with prolonged sitting, standing and ambulation.He had been having some cramping in his lower extremities.Impression: chronic low back pain, history of degenerative disk disease.Fusion, with diskitis.Anxiety and insomnia.Hypertension.Chronic obstructive pulmonary disease.On (b)(6) 2011: the patient presented for cough.Assessment: acute bronchitis; chronic airway obstruction; hypertension.On (b)(6) 2011: the patient presented for follow-up with ear pain and history of hypertension.On (b)(6) 2013: the patient presented with flank pain and dysuria.The patient underwent ct of abdomen and pelvis due to possible kidney stone.Impression: stone proximal left ureter with obstruction.On (b)(6) 2014: the patient underwent x-rays of the lumbar spine due to lumbago.Impression: no acute fracture; alignment at l5-s1 appears be slightly improved.On (b)(6) 2014: the patient presented with the following pre-operative diagnosis: non-healing lesion with itching, burning, and bleeding on the right forearm; the size of the lesion is 2.5 x 1.5 cm in diameter.He underwent the following procedure: excision of lesion of the right forearm.No patient complications were reported.On (b)(6) 2014: the patient underwent ct of lumbar spine due to lumbago.Impression: prior fusion l4-l5 l5-s1; djd especially the facet joints and disc bases of l4-l5, l5-s1.On (b)(6) 2014: the patient underwent colonoscopy.On (b)(6) 2014: the patient presented for evaluation of colon.He also had back pain.Assessment: screening for colon cancer.On (b)(6) 2014: the patient underwent x-ray of the chest due to hypertension.Impression: borderline heart size and mild interstitial c hange; no acute infiltrate.On (b)(6) 2014: the patient presented with the following pre-operative diagnosis: screening colonoscopy.He underwent the following procedures: complete colonoscopy to the cecum.Rectosigmoid polyp removal in piecemeal fashion.He had the following postoperative diagnosis: rectosigmoid junction sessile polyp, 0.5 x 0.5 cm.No patient complications were reported.On (b)(6) 2014: the patient presented for follow-up of hypertension and cholesterol level.On (b)(6) 2014: the patient underwent multiple views of lumbar spine.Impression: no acute fracture; alignment at l5-s1 appeared slightly improved.On (b)(6) 2014: the patient presented with low back pain.Assessment: chronic low back pain; hypertension.He underwent the following procedure: excision of lesion on the right forearm.On (b)(6) 2014: the patient presented with low back pain.Assessment: chronic low back pain; hypertension.On (b)(6) 2014: the patient underwent ct of lumbar spine.Impression: fusion l4-l5 l5-s1; djd especially in the facet joints and disc bases of l4-l5 l5-s1.On (b)(6) 2014: the patient presented with cough.Assessment: bronchitis; anxiety; chronic airway obstruction; hypertension.He underwent x-rays of the chest due to bronchitis.Impression: mild interstitial changes and emphysema.On (b)(6) 2015: the patient presented for follow-up with low back pain.Assessment: allergic rhinitis; anxiety; chronic low back pain.On (b)(6) 2015: the patient presented with hypertension and chest pain.He underwent x-rays of the shoulder.Impression: moderate osteoarthritis.After the rhbmp-2/acs surgery, the patient cannot stand or sit for any length of time without pain.The pain radiates down his left leg and his left foot stats numb all the time.His back pain is constant and his sex life had suffered.
 
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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 Key4392413
MDR Text Key5433525
Report Number1030489-2015-00045
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 01/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/01/2011
Device Catalogue Number7510400
Device Lot NumberM110802AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2014
Initial Date FDA Received01/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received11/24/2015
01/20/2016
02/08/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/04/2009
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 Weight115
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