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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Headache (1880); Muscle Spasm(s) (1966); Neuropathy (1983); Vomiting (2144); Tingling (2171); Stenosis (2263); Numbness (2415); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(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.
 
Event Description
Per medical records: it was reported that on : (b)(6) 2004 , the patient presented with right trochanteric bursitis interfering with her physical therapy for resolution of previously diagnosed sciatica.(b)(6) 2004 , the patient presented with foraminal stenosis, spinal stenosis and lumbar radiculopathy.Using c-arm fluoroscopy, the ap, lateral, and oblique views of the target facet joints were identified.Lidocaine was injected into the nerve root sleeve.(b)(6) 2005 , the patient presented with failed back syndrome, lumbar radiculopathy, epidural scar tissue.(b)(6) 2007, the patient presented with left c7-tl disk herniation with associated radiculopathy.He underwent following procedure - anterior cervical, diskectomy, decompression, and fusion c7-t1 utilizing fibular graft with dbm autogenous bone supplement with trinica plating in conjunction with c-arm imaging and intraoperative monitoring.A microscopic examination has been performed and the finding incorporated into the diagnosis (b)(6) 2005 , the patient was noted to have painful right lower extremity.Impression: allodynia right lower extremity.(b)(6) 2007 , the patient presented for evaluation and treatment of her pain.Impression : mri of cervical spine: postsurgical changes of discectomy and anterior fusion at c5-c6 and c7-t1 are seen (b)(6) 2007 , the patient presented with cervical foraminal stenosis, c7-t1 on the left.2.Cervical radiculitis.She was given selective nerve root injection at the level of c7 and t1 on the left side under fluoroscopy.(b)(6) 2007, the patient presented for lab examinations including urine screening, cbc ,cmp,u/a , cxr, ekg , screen pregnancy.Results : multiple organisms present, each less than 10,000 cfu/ml_ these organisms, commonly found on external and internal are considered to be colonizers.No further testing performed.(b)(6) 2007 , the patient presented with preop diagnosis -cervical pseudoarthroses c5-6, c7-t1; degenerative disk disease stenosis c6-7; radiculopathy.Per op notes , she underwent following procedures:- exploration of fusion; removal of instrumentation c5-6, c7- t1; anterior cervical diskectomy and fusion with peek interbody cages, bone morphogenic protein and c5-6, c6-7, c7-t1.Surgical procedure:- carefully at each level, c5-6 being performed first the surgeon removed the attempted fusion material and working his way posteriorly removed extensive amount of scar tissue back to the posterior longitudinal ligament.The surgeon then freed up the posterior longitudinal ligament from its attachments to the inferior and superior aspects of the involved vertebra and debrided the posterior lips of the vertebra to remove osteophytes as well as the posterior thirds of the uncovertebral joints.Completing that and having debrided down to good bleeding subchondral bone.He now sized for the appropriate size cage which was filled with half an rhbmp-2 soaked , sponge and carefully impacted into position.This procedure was followed at both c5-6 and at c7-tl.Both gave good distraction and good fixation.Now the surgeon moved to c6-7 ,sized for an appropriate size cage which was a 6 mm and put half of an rhbmp/2 soaked sponge in it and carefully impacted into position.The surgeon chose the 55 mm plate and anchored it at each level with un icortical screws either 12 or 14 mm.X-rays showed these to be in satisfactory position.The surgeon did have to work around the holes from the previous plate and this did cause some contortion at c6 and c7 but the fixation was solid.Locking caps were then placed over the screws.(b)(6) 2007 , the patient presented with severe cervical radiculitis secondary to c6-7 degeneration and failed fusions at c5-6 and c6-t1 as well as a large thyroid goiter.She underwent following procedure left thyroid lobectomy.She has had ent evaluation to make sure that her vocal cords are functioning normally, and at this time, we will proceed to explore the fusion with removal of instrumentation and revise the fusions if they are found not to have healed.We will also proceed with , c6-c7 anterior cervical discectomy and fusion.We will use bone morphogenic protein due to the high risk of failure we are dealing with here.(b)(6) 2007, she was afebrile, vital signs were stable.She continues to have some right lower extremity pain for which a ct scan was done on (b)(6) 2007 , the patient presented with preop diagnosis for abnormal stress test.She underwent left heart cath.; selective coronary angiography.; lv angiogram ; right femoral angiogram.;right femoral artery angioseal.Impression : normal coronary arteries by angiogram.(b)(6) 2007 , the patient underwent some radiography examination of cervical spine.(b)(6) 2007, the patient was issue disability certificate starting date (b)(6) 2007 to (b)(6) 2007.(b)(6) 2008, the patient presented with pain with numbness and tingling in the left shoulder and underwent mri examination of the cervical spine without and with intravenous contrast infusion.(b)(6) 2008, the patient underwent mri examination of the brain without and with intravenous contrast infusion.(b)(6) 2008, patient presented for mri of the cervical spine.Impression : postsurgical anterior cervical fusion in the mid to lower cervical spine.There is no significant abnormal scar tissue.Mild to moderate left neural foraminal is identified at c4-c5 and c5-c6 as described secondary to uncovertebral hypertrophic changes (b)(6) 2008, the patient presented with neck pain and left greater than right arm pain.Preop diagnosis: 1.Left-sided neck pain.2.Left greater than right cervical radiculitis.3, cervical postlaminectomy pain syndrome.4.Cervical neural foraminal stenosis at c4-c5 and c5-c6.Following procedure was reportedly performed - l.C6-c7 epidural steroid injection, left of midline approach.2.Fluoroscopic needle localization.(b)(6) 2008, the patient was here for follow up of her pain and physical examination.(b)(6) 2008, the patient presented with the following preop dx.-1.Axial neck pain.2.History of left shoulder pain.3.Post cervical fusion neck pain.The procedures he underwent - left prognostic medial branch nerve blocks at: c3, c4 , c5, c6, c7.2.Fluoroscopic needle localization.(b)(6) 2008, the patient presented for re-evaluation.She continued to complain of left shoulder pain.(b)(6) 2007; (b)(6) 2008, the patient presented for pt.(b)(6) 2008, the patient presented for re-evaluation.Impression: she continued in physical therapy for both her knees and shoulder.(b)(6) 2008, the patient underwent mr lumbar spine w or w/o contrast.Impression : postoperative changes at l5-s1.Spondylosis changes particularly at l4-l5.Neural foraminal stenosis is present at l4-l5.(b)(6) 2008; (b)(6) 2009, patient presented for f/u emg/ncv.She continues pt for shoulder complaint.Interpretation : despite clinical suspicion of lumbar radiculopathy, no electro diagnostic evidence of lumbar radiculopathy detected in the areas sampled today.(b)(6) 2009, the patient presented with radiculopathy and underwent ct of the cervical spine.Multiple axial images were obtained through the lumbar spine, without the use of intravenous contrast material.Sagittal and coronal reconstructions are also presented for evaluation.Impress: postop changes and degenerative disc disease as discussed above.(b)(6) 2009, the patient presented to the pain clinic for initial consult with chief complaint of chronic, persistent constant pain originally in the lower part of the lumbar spine, postoperative area.(b)(6) 2009, the patient presented for reevaluation status post her left shoulder surgery and review of x-rays of the lumbar and cervical spine as well as ct of the cervical spine.Impression : normal chest x-rays.(b)(6) 2009, the patient presented for radiofrequency ablation cervical medial branches on the left side, including third occipital nerve, c3, c4, cs, c6, c7, and t1 under fluoroscopic guidance.Next day , the patient reported just a slight headache in the frontal area.Ct angiography showed good open right vertebral artery, good blood supply to the base of the brain from the right vertebral artery and from carotid artery, and there was not visualized, left vertebral artery.Patient was given epidural spine injections.(b)(6) 2009, patient reported pain in the cervical spine is deep and aching with muscle spasm, occasionally sharp e specially with cervical spine movement.Assessment :- 1.Status post revision surgery, cervical spine, posterior approach, on (b)(6) 2009 due to nonunion of prior c7 -t1 fusion.2.Status post c5 to t1 cervical spine fusion with anterior plate placement.3.C5-6, c6-7, c7-t1, t1-t2 foraminal stenosis, more pronounced c7-t1 on the left side.4.Cervical degenerative disc disease c3-c4, c4-c5, more pronounced c3-c4 with joss of disc height more than 40%.5.Small degree spondylolisthesis c3 over c4.6.Cervical spondylosis c2-3, c3-4, c4-5 most pronounced c3-4, c4-5 worse on the left side.7.Occipital neuralgia - tension type headache worse on the left side.8.T1-2 versus t2-3 disc herniation with possible left foraminal stenosis.9.Rule out instability t1-t2 segment.10.Cervical radiculopathy c8 distribution on the left side.11.Cervical epidural adhesions.-12.Status post l5-s1 laminectomy/discectomy and l5 to s1 fusion with posterior instrumentation on the right side only.Left side was removed due to postoperative infection.13.L4-l5 diffuse disc bulge/herniation, right lateral recess.14.Right l4-l5 neural foraminal stenosis.15.Spinal canal stenosis l4-l5 level, moderate degree, due to facet arthropathy, diffuse disc bulge.16.Right l4, ls, s1 radiculopathy more pronounced in l5 distribution.17.Lumbar facet arthropathy l4-l5, l5-s1 bilaterally worse on the right side.18.-right sacroiliac joint pain.19.Right leg pain.(b)(6) 2009 , the mri scan of patient revealed some mild degenerative changes of her ac joint; otherwise, un-remarkable mri of her left shoulder.Impression :- 1.Unremarkable mri of the thoracic spine.2.Postsurgical changes from previous cervical fusion.(b)(6) 2009, the patient presented with reports that she completed x-rays and mri of the lumbar spine and brought films to review x-rays and mri of the lumbar spine and complained of pain in the lower part of the cervical spine predominantly on the left side.Additional data that were reviewed included x-ray of the cervical spine , mri of the cervical spine.Impression: this is a female with a history of cervical and lumbar surgery in the past, cervical radiculopathy and post-cervical surgery (b)(6) 2009 , patient presented for f/u status post her office visit.(b)(6) 2009, the patient presented with cervical stenosis and underwent physical examination , ct /cervical spine reviewed which was performed on (b)(6).(b)(6) 2009 , the patient presented for ct of lumbar spine.Impression:- disc evaluation is limited on ct.Disc bulge at l4-l5 is suspected with mild canal narrowing.Postsurgical changes at l5-s1 are present (b)(6) 09, the patient presented with preop diagnosis - cervical stenosis and radiculopathy.Procedure performed - c5-6, c6-7, c7-71 left laminotomy foraminotomy.X-rays were once again taken to confirm position and we also performed intraoperative ct scan to evaluate the foraminal stenosis.(b)(6) 2009, the patient called to inform severe headache, vomiting, sleeping disorder.She was prescribe d/refilled with medicine.(b)(6) 2008; (b)(6) 2009 , the patient presented for f/u and evaluation on her work status /disability and medicine refill.(b)(6) 2009, the patient presented for evaluation/follow up visit, refill of medication.Assessment :- 1.Status post revision surgery, cervical spine, posterior approach, on (b)(6) 2009 due to nonunion of prior c7 -t1 fusion.2.Status post c5 to t1 cervical spine fusion with anterior plate placement.3.C5-6, c6-7, c7-t1, t1-t2 foraminal stenosis, more pronounced c7-t1 on the left side.4.Cervical degenerative disc disease c3-c4, c4-c5, more pronounced c3-c4 with joss of disc height more than 40%.5.Small degree spondylolisthesis c3 over c4.6.Cervical spondylosis c2-3, c3-4, c4-5 most pronounced c3-4, c4-5 worse on the left side.7.Occipital neuralgia - tension type headache worse on the left side.8.T1-2 versus t2-3 disc herniation with possible left foraminal stenosis.9.Rule out instability t1-t2 segment.10.Cervical radiculopathy c8 distribution on the left side.11.Cervical epidural adhesions.-12.Status post l5s1 laminectomy/discectomy and l5 to s1 fusion with posterior instrumentation on the right side only.Left side was removed due to postoperative infection.13.L4-l5 diffuse disc bulge/herniation, right lateral recess.14.Right l4-l5 neural foraminal stenosis.15.Spinal canal stenosis l4-l5 level, moderate degree, due to facet arthropathy, diffuse disc bulge.16.Right l4, ls, s1 radiculopathy more pronounced in l5 distribution.17.Lumbar facet arthropathy l4-l5, l5-s1 bilaterally worse on the right side.18.-right sacroiliac joint pain.19.Right leg pain.(b)(6) 2009; (b)(6) 2010, the patient presented for f/u of emg performed on (b)(6) 2010.(b)(6) 2009; (b)(6) 2010, the patient presented for pt.(b)(6) 2010 , the patient presented for sensory and motor conductions were performed in the left arm.(b)(6) 2010 mri: c4-5: mild disc desiccation.Mild endplate spondylosis.Left greater than right uncovertebral joint arthrosis and facet degeneration with mild to moderate left neural foraminal narrowing.Minimal effacement of the anterior thecal sac is seen.No neural foraminal stenosis on the right.C5-6: postsurgical change visualized in this level.No disc bulge or herniation seen.Mild endplate spondylotic changes are visualized and uncovertebral joint degeneration.No significant neural foraminal narrowing.No central spinal canal stenosis.C6-7: mild disc desiccation and post surgical changes are seen anteriorly at this level.Mild endplate spondylosis.No central spinal canal stenosis.Mild to moderate left uncovertebral joint and facet arthrosis with moderate left neural foraminal narrowing.No significant right neural foraminal narrowing.C7-t1: mild disc desiccation.Postsurgical changes are seen anteriorly.Mild endplate spondylosis.Mild bilateral uncovertebral joint arthrosis with mild light and minimal left neural foraminal narrowing.No significant central spinal canal stenosis.(b)(6) 2011 , the patient presented for general assessment of her health and to get her mri cervical spine reviewed.Impression patient does have significant upper chest pain which could be related to these disc herniations or potentially her shoulder or potentially her ongoing back complaints.
 
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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 Key5077438
MDR Text Key25815297
Report Number1030489-2015-02341
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
Reporter Occupation Attorney
Type of Report Initial
Report Date 08/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/01/2009
Device Catalogue Number7510200
Device Lot NumberM115007AAI
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/24/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/28/2006
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 Weight76
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