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

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

Patient Problems Chest Pain (1776); Edema (1820); Fever (1858); High Blood Pressure/ Hypertension (1908); Impotence (1925); Nausea (1970); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Vertigo (2134); Weakness (2145); Dizziness (2194); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4): neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on: (b)(6) 2009: the patient presented with the following preoperative diagnosis: significant cervical spondylosis, c5-6, with significant radiculopathy; previous fusion and instrument at c6-7 with nonunion at this level and persistent pain.He underwent the following procedures: exploration of c6-7 fusion area, removal of plate, evaluation of fracture, c6 partial median corpectomy with decompressions at c5-6 and c6-7 (microscopic technique), fusion cages and instrument plating c5 to c7.Per op notes, dissection was carried superior to c6-7 plate to identify the c5-6 disk space.The screws were then removed.The screws in the upper aspect of c6 had virtually no purchase.The screws in c7 had fair purchase.The plate was removed.It was inspected and the screws in the superior aspect of c6 had fractured the superior aspect of c6 significantly such that diskectomy and fusion at that level could not be adequately performed.The c6-7 level did show evidence of nonunion.It was therefore felt that we needed to perform corpectomy of c6 and decompression at c6 and c7.The appropriate height for cages was chosen.This construct was then filled with the patient's local autologous bone.With anesthesia causing gentle traction on the neck, the construct was tapped and countersunk in it.It was quite snug and stable.Weight was removed from the halter traction.A 35 mm plate was chosen and affixed to c5 and c7 with 2 x 15 mm self-drilling screws at each level (a total of four screws).Screw purchase was quite good.The platysma muscle was closed.No patient complications were reported.The patient had the following postoperative diagnosis: same as pre-operative diagnosis with evidence of significant fracture of superior aspect of c6 secondary to motion at this level.(b)(6) 2010: the patient presented for follow-up.He had a c5 corpectomy for fracture of previous cervical fusion.He had somewhat osteoporotic bone, plus he had a syringomyelia and somewhat weaker neck muscles because of that.(b)(6) 2010: the patient presented with the following pre-operative diagnosis: cervical instability c5-6, c6-7, status post anterior cervical corpectomy c6; cervical spondylitic disease and cervical myelopathy.He underwent the following procedures: posterior cervical fusion with alignment instrumentation c5, 6, 7, with rh-bmp2/acs, local bone graft.Per op notes, after performing decompression, rh-bmp2/acs and the local bone was placed in the lateral gutter area.Most of the rh-bmp2/acs was placed on the right side as the patient had the foraminotomies on the left side and the fear was that some of the rh-bmp2/acs would ooze into the neuroforaminal area and could cause calcification on the nerve root.Once all this was completed and the bone grafts felt to be adequate, jackson-pratt drain was then closed.It came inferiorly in the skin incision and was secured to the skin.No patient complications were reported.(b)(6) 2010: the patient presented for an office visit for complaints of edema.He had problems of his leg swelling.The patient also had back pain, muscle pain, dizziness and incoordination problems.The patient underwent transthoracic echo test.The patient underwent x-rays of the chest.Impression: 1.Atelectasis/consolidation in the left lower lobe.Pneumonia is a differential consideration.2.Postoperative change in the chest.Stable enlargement of the cardiac silhouette.3.Incompletely seen postoperative cervical spine.He also underwent echocardiography due to dyspnea.Impression: 1.Normal left ventricular systolic function with an ef of 60%.2.Hyperdynamic lv without obvious wall motion abnormalities.3.Mild/mod lvb and mild lae noted.4.Mild tr noted.5.Trivial tr noted.6.Pericardium was normal, without effusion.7.No clots, masses, or veggies noted.(b)(6) 2010: the patient presented for an office visit.(b)(6) 2010: the patient presented for follow-up with some intermittent numbness to his left thumb, index and long fingers.Physical examination revealed decreased range of motion.Patient underwent cervical x-rays as a postoperative follow-up.Impression: 1.Postoperative changes of a c6 corpectomy with anterior plate and screw fixation with an interval posterior cervical fusion with no periprosthetic abnormality.2.No other interval change.(b)(6) 2010: the patient presented for follow-up visit with occasional thumb, index and little finger discomfort, which had been present since surgery.Patient underwent x-rays of cervical spine as a postoperative follow-up.Impression: 1.Postoperative changes of a c6 corpectomy with no periprosthetic abnormality.2.Anatomic alignment.3.Unremarkable remaining levels.(b)(6) 2011: the patient presented follow-up for his chronic conditions.Assessment: diabetes mellitus type 2; hypertension; hyperlipidemia; degeneration of cervical intervertebral disc; screening for malignant prostate neoplasm.(b)(6) 2011: the patient presented for follow-up for hyperlipidemia.(b)(6) 2011: the patient presented with abdominal pain.He also had low back pain and abdominal pain, bilaterally.The pain radiated into his side and up his back.(b)(6) 2011: the patient presented with fever.Associated symptoms included productive yellow sputum cough, dyspnea, fatigue, headache, nausea, sore throat.Assessment: bronchitis.(b)(6) 2011: the patient presented for follow-up for chronic conditions.Assessment: diabetes mellitus type 2; hypertension; hyperlipidemia; degeneration of cervical intervertebral disc.(b)(6) 2011: the patient presented for an office visit for his diabetes follow-up.(b)(6) 2011: the patient presented with complaint of vertigo.(b)(6) 2011: the patient underwent ct of abdomen and pelvis due to rectal pain.Impression: the liver, spleen, kidneys, and pancreas appear within normal limits; vascular calcifications; enlarged prostrate.(b)(6) 2011: the patient presented for an office visit for checking of a rash on his left elbow and legs probably due to exposure to radiation working at "srs".(b)(6) 2011: the patient presented for an office visit.(b)(6) 2012: the patient presented with low back pain radiating into his legs.He also complained of weakness.(b)(6) 2012: the patient presented for an office visit.He had some chest pain.He underwent electrocardiography.He also underwent chest x-rays due to chest pain.Impression: status post coronary bypass surgery; cardiomegaly; no acute infiltrates are seen.(b)(6) 2012: the patient underwent polysomnography due to right sided chest pain.(b)(6) 2012: the patient underwent polysomnography due to known coronary artery disease.Results: 1.Ejection fraction is normal at about 60 or 65% with no wall motion abnormalities.Ao pressures were 97/49.End-diastolic pressure was 23.2.Lima to the left anterior descending is patent.3.Saphenous vein graft to the om is patent.4.Vein graft to the right-coronary artery has 100% occlusion.5.Distal left main has a 70% eccentric stenosis.6.Circumflex and obtuse marginal branches are diffusely diseased with multiple 80 to 90'% stenoses.7.The left anterior descending in the proximal portion has a total 100% occlusion with distal left anterior descending lima graft.8.The right coronary artery is diffusely diseased with multiple 80 to 90% lesions in the mid portion.This is a diffuse long lesion.(b)(6) 2012: the patient presented for an office visit.He had left arm pain.(b)(6) 2012: the patient presented for an office visit for hyperlipidemia.(b)(6) 2012: the patient presented for an office visit.He had noticed some bright blood per rectum when he wiped on two occasions, the previous day.He described some discomfort when he sits down in his buttock region.One complicating factor was that the patient had two coronary stents placed about two months ago.(b)(6) 2013: the patient presented for an office visit.(b)(6) 2013: the patient underwent ct of abdomen and pelvis due to abdominal pain.Impression: normal ct; possible early pancreatitis; clinical correlation needed; no evidence of pancreatic abscess or infarct; normal contrast enhanced ct scan of the pelvis; vascular calcification; arthritic changes in the hips and pelvis and lower lumbar spine.(b)(6) 2013: the patient presented with abdominal pain.It was consistent with what he had with the pancreatitis.He also had neck p ain.(b)(6) 2013: the patient presented for an office visit with back pain, joint pain and joint stiffness.He also had numbness and paresthesias.(b)(6) 2013: the patient presented for an office visit for organic origin impotence.He underwent the following procedure: testosterone cypionate, 1 cc, 200 mg.(b)(6) 2013: the patient presented for an office visit for erectile dysfunction.He underwent the following procedure: testosterone cypionate, 1 cc, 200 mg.(b)(6) 2013: the patient presented for an office visit.(b)(6) 2013: the patient presented with benign paroxysmal positional vertigo.(b)(6) 2013: the patient underwent mri of brain due to dizziness and giddiness.Impression: minimal chronic microvascular ischemic change within the white matter, but otherwise no acute finding within the brain parenchyma.(b)(6) 2013: the patient presented with head congestion, ear fullness and some drainage.(b)(6) 2013: the patient underwent stress test due to previous coronary bypass surgery, chest pain on exertion suggestive of recurrent angina.Conclusion: abnormal cardiolite treadmill stress test producing severe chest pain and dyspnea, left bundle-branch block develops at 106 heartbeats per minute, and the ejection fraction is reduced at 42% with septal hypokinesis and apical dyskinesis and there is an inferoposterior and lower septal area of mild ischemia present.06 dec 2013: the patient underwent "cardiac cath" test.(b)(6) 2014: the patient presented with right lower quadrant abdominal pain for about a week.He also complained of constipation.Assessment: abdominal pain in right lower quadrant; constipation.(b)(6) 2014: the patient underwent ct of the abdomen and pelvis, due to abdominal pain and right lower quadrant pain.Impression: 1) vascular calcification aorta and renal arteries.2) no acute abnormality present.

• 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: 5044357
• MDR Text Key: 24656514
• Report Number: 1030489-2015-02142
• 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
• Reporter Occupation: Attorney
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• 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
• Date Manufacturer Received: 08/03/2015
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Weight: 106