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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 Apnea (1720); Chest Pain (1776); Neuropathy (1983); Tingling (2171); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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) 2008 the patient underwent anterior interbody fusion surgery on the lumbar region of his spine from vertebrae l4 to l5 using rhbmp-2 and collagen sponge which was placed outside the cage.Post-op complications: increasingly severe and chronic lower back pain, neuropathy in feet and toes, loss of feeling in groin area, difficulty in sitting and walking, bladder issues, and sexual issues.These serious injuries prevent patient from practicing and enjoying the activities of daily life.
 
Event Description
It was reported that on: (b)(6) 2008: patient presented with a visit due to complaint of back pain.Impressions: discogenic back pain at the l4-l5 back level.Patient was presented with following pre-op diagnosis: lumbar segmental instability and underwent following procedure: l4/5 anterior lumbar interbody fusion surgery using bone morphogenic protein with percutaneous screw fixation.Retroperitoneal approach.Anterior plate fixation.Per op-notes: ¿ after the retroperitoneum had been reached and the l4/5 disk space identified and confirmed by fluoroscopy, dissection continued mobilizing the left common iliac vein all the way to right across the midline.The l4/5 disk space was incised, entered, and a complete discectomy was carried out removing all the disk material to the level of the annulus.Cartilagineous endplates were taken down to good bleeding subchondral bone in preparation for the fusion.Templating was done and the interbody implant 12 mm tall, large, 8 degrees lordosis made of peek was chosen.The central hollow core was filled with bmp which had been reconstituted and dripped onto absorbable collagen sponges.The implant was then impacted into the place and countersunk.Additional sponges were then placed lateral and anterior to the implant.Then templating for an anterior plate was carried out.The screw instrumentation system was used, plate was then held flush to the spine and attached with three screws.Potholes were made with an awl.The l4 screw was 6.5 mm in diameter and 30 mm in length.L5 screws were 6.5 mm in diameter and 25 mm diameter in length.Two screws were placed at that level.Locking plate was then secured to prevent screw backout.Fluoroscopy was taken to ensure optimal positioning of the implant as well as the hardware.Patient suffered no complications." on (b)(6) 2008: patient also underwent an x-ray exam of the l-spine in 2 or 3 views due to back pain.Impressions: discectomy at l4-5 with insertion of prosthetic disc.Anterior fusion with metal plate and internally fixating screws.On (b)(6) 2008: patient was discharged from the hospital.On (b)(6) 2008: patient presented with a post-op follow-up visit.The pre-op spinal pain is gone.Incision was healing.On (b)(6) 2008: patient underwent an x-ray examination.Impressions: no evidence of deep or superficial vein thrombosis in the right or left leg.On (b)(6) 2008: patient presented with a post-op follow-up visit.On (b)(6) 2008: patient called to request for medication refills.On (b)(6) 2008: patient underwent an x-ray due to history of back pain and surgical fixation.Impressions: interbody and anterior fusion at the l4-l5 level similar as compared to the prior study.No spondylolisthesis or underlying acute fracture seen.On (b)(6) 2008: patient presented with a post-op follow-up visit due to achiness and pain associated with sudden twisting movements.Patient also suffered from depression.On (b)(6) 2009: patient presented with a post-op follow-up visit.Patient doing good.On (b)(6) 2009: patient presented with a follow-up visit.On (b)(6) 2009: patient presented for a follow-up visit in which the recent x-ray of his reconstructive surgery was reviewed from (b)(6) 2009.Patient has a robust l4-5 anterior lumbar interbody fusion.Trabecular bone formation was seen.Hardware is well positioned.On (b)(6) 2009: patient underwent split night sleep study.Assessment: patient had severe obstructive sleep apnea/ hypopnea syndrome.On (b)(6) 2009: patient presented for colon neoplasm.Diagnosis: gastroesophageal reflux disease, esophagitis.Screening for colon neoplasm.On (b)(6) 2009: patient presented with following pre-op diagnoses: gastroesophageal reflux disease, esophagitis, screening for colon neoplasm.For which, patient underwent following procedures: esophagogastroduodenoscopy.Biopsy of duodenal polyp.Random biopsy pf gastric mucosa.Biopsy of distal esophagus to check for barrett esophagus.Total colonoscopy.Patient tolerated the procedure well with no complications reported.After which, patient had post-op diagnoses as: polyp duodenum, mild gastritis, mild esophagitis, normal sized prostate.No neoplasm to colon and rectum.Moderate diverticulosis sigmoid colon.On (b)(6) 2011: patient underwent ultrasound of the right upper quadrant of the abdomen.Impression: mild diffuse fatty liver replacement is suggested.No focal liver mass.No sonographic abnormality of the gallbladder.On (b)(6) 2012: patient presented with an office visit due to chest pain.Patient was diagnosed with: chest pain atypical, suspected costochondritis.Gerd (gastroesophageal reflux disease).Depression.Patient was admitted.Patient also underwent a radiology exam.Impressions: left basilar opacity obscuring the hemidiaphragm, atelectasis versus infiltrate.Follow-up to document resolution is recommended.A small left effusion cannot be excluded.Patient also underwent a ct scan of the chest due to left base density.Impression: minimal left base atelectasis, fatty liver, no further evaluation thought to be necessary.On (b)(6) 2012: patient underwent a 2-d transthoracic echocardiogram with color flow and doppler study.Patient also underwent a nuclear medicine myocardial perfusion study due to chest pain.Impressions: negative for reversible ischemia or infarction; 63% lvef with no regional wall motion abnormalities.On (b)(6) 2012: patient presented with complaint of chest pain.Patient also underwent x-ray of chest.Impression: no prior studies were available for comparison.Apparent widening of the superior mediastinum is likely related to flat and portable techniques.The heart is normal in size.The lungs are clear.There was no pneumothorax.Patient also underwent ct of chest, abdomen, and pelvis without and with intravenous contrast.Impression: normal aorta and major branch vessels.There were no findings to account for differential blood pressure in the 2 arms.No evidence of pulmonary embolism.No acute abnormalities within the chest, abdomen or pelvis.Patient also underwent multiplanar, multi-weighted mri of the cervical, thoracic and lumbar spine was performed without and with intravenous contrast using standard protocol.Impression: post-surgical changes from prior anterior discectomy fusion procedure at l5-s1, with superimposed mild spondylosis involving the lumbar spine.No significant central canal or neuroforaminal stenosis is identified.No enhancing lesions are noted within the spine.On (b)(6) 2012: patient complained of pain, all over.Patient underwent mri of lumbar and thoracic spine without contrast.Impression: mild diffusions restrictions noted from the mild thoracic spinal cord inferiorly to the level of the conus.Given associated t2/stir signal hyperintensity noted within the spinal cord on the prior study, this finding may represent a spinal cord infarct, or alternatively a longer segment of demyelination.On (b)(6) 2012: patient underwent mri of brain and brainstem with and without contrast.Impression: normal brain mri.On (b)(6) 2012: patient underwent x-ray of chest.Impression: comparison is made with the prior examination dated (b)(6) 2012.There has been interval placement of a right arm peripherally inserted central venous catheter ending in the superior vena cava.There is no pneumothorax or pleural effusion.The lungs are free of focal consolidations.The heart size is normal.The aorta is tortuous.The mediastinal contours are unchanged.On (b)(6) 2012: patient got discharged with principal and secondary diagnosis as: cord disease and small fiber neuropathy.Depression.Gastroesophageal reflux disease.L4-l5 spinal fusion in 2008.On (b)(6) 2012: patient presented for health risk screening and follow up of his cord disease and small fiber neuropathy on (b)(6) 2012: patient underwent mri of thoracic and lumbar spine without contrast due to history of bilateral upper extremity and lower extremity tingling.Impression: the t2 signal hyperintensities noted within the spinal cord on the previously study dated (b)(6) 2012 are not appreciated on this exam.Postsurgical changes of prior anterior discectomy with fusion at l4-5 as described.Mild neuroforaminal stenosis in the lumbar spine and no significant canal stenosis.On (b)(6) 2014: patient underwent ultrasound of right upper quadrant of the abdomen.Impression: no sonographic abnormality of the right upper quadrant of the abdomen.On (b)(6) 2014: patient underwent x-ray of chest.Impression: no evidence of active pulmonary infiltration.On (b)(6) 2014: patient presented with following pre-op diagnoses: ¿gerd¿, dysphagia, changed in bowel habits- screening colonoscopy.Very strong family history of malignancy.For which, patient underwent following procedures: esophagogastroduodenoscopy with biopsy of distal esophagus and esophageal dilation.Colonoscopy to the cecum with polypectomy with hot biopsy forceps.Patient tolerated the procedure well with no complications reported.On (b)(6) 2014: patient presented for an office visit with following diagnoses: diarrhea, benign neoplasm, esophagitis, esophageal, diarrhea, and dysphagia.On (b)(6) 2014: patient presented with complaint of epigas pain, chest pain, ¿ruq¿ pain fro which patient underwent ultrasound.On (b)(6) 2014: patient underwent ultrasound of right upper quadrant of the abdomen.Impression: no sonographic abnormality of the right upper quadrant of the abdomen.On (b)(6) 2014: patient underwent ¿hida¿ scan with gall bladder ejection fraction.Diagnosis: negative ultrasound, epigas pain, chest pain, ¿ruq¿ pain.On (b)(6) 2014: patient underwent nuclear medicine hepatobiliary scan with gallbladder ejection fraction.Impression: normal hepatobiliary scan.
 
Event Description
It was reported that on (b)(6) 2008: patient presented with a post-op follow-up visit.Patient underwent ¿xr l-spine al\t\lat 2 views¿ examination.Impression: ¿discectomy at l4-l5 with insertion of prosthetic disc and anterior fusion.On the lateral view the prosthetic disc does superimpose the interspace of ll4-l5.It is some what difficult to localize on the ap view.¿ on (b)(6) 2009: patient presented with a follow-up visit.Patient underwent ¿xr l-spine any 2 or 3 views¿ examination.Impressions: stable anterior fusion l4-5.No malalignment.No hardware complication.On (b)(6) 2009: patient presented for following diagnosis ¿ s/p alif l4-l5¿.On (b)(6) 2009: patient presented for following diagnosis: ¿s/p alif ¿ lumbar segmental instability¿.On (b)(6) 2009: patient presented for office visit.On (b)(6) 2009: patient presented for follow up visit.Patient underwent ¿xr l-spine 3v ap, lat\t\ls¿ examination.Findings: anterior fusion plate and coil are present at the l4-l5 level in stable position.No hardware complication is seen.No malalignment.Bone mineralization is normal.All pedicles are present in ap film.Slight facet arthropathic changes l1-l5 level.No pars defect or subluxation.On (b)(6) 2015: patient underwent x-ray of knee due to knee pain.Impression: no evidence of abnormality of right knee.On (b)(6) 2015: patient underwent mri of right knee without contrast due to knee pain.Impression: evidence of a medial meniscal tear with a small, sub centimeter, para meniscal cyst.On (b)(6) 2016: patient underwent x-ray of lumbar spine due to low back pain.Impression: postoperative features from anterior and inter-body fusion at l4-l5.Moderate spondylosis.Patient also underwent x-ray of hip due to right hip pain.Impression: normal right hip series.On (b)(6) 2016: patient underwent mri of lumbar spine without contrast due to lumbar radiculopathy.Impression: approximate 9 mm focal region of signal abnormality is seen within the right anterior aspect of the spinal canal at l5-s1 near the origin of the right s1 nerve root.Favor that this represents a focal disc extrusion, possibly a sequestered fragment.A nerve root growth is less likely, recommend consideration foe a follow up contrast mri of lumbar spine.Post surgical changes at l4-5.Facet arthropathy seen about the lower lumbar spine.On (b)(6) 2016: the patient underwent colonoscopy to the cecum and terminal ileum.
 
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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 Key5388124
MDR Text Key36754951
Report Number1030489-2016-00246
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,Followup,Followup
Report Date 06/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2010
Device Catalogue Number7510400
Device Lot NumberM110706AAF
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/15/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/18/2008
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 Weight98
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