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

Catalog Number 7510200

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

Patient Problems Arthritis (1723); Atherosclerosis (1728); Chest Pain (1776); Cyst(s) (1800); Edema (1820); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Ischemia (1942); Neuropathy (1983); Rash (2033); Scarring (2061); Urinary Tract Infection (2120); Burning Sensation (2146); Tingling (2171); Cramp(s) (2193); Stenosis (2263); Anxiety (2328); Depression (2361); Numbness (2415); Sweating (2444); Sleep Dysfunction (2517); Claudication (2550); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on: (b)(6) 2002: the patient underwent bilateral screening mammography due to asymptomatic breast screening.Impression: heterogeneously dense breasts.There is no mammographic evidence of malignancy.Bi-rads category 2.Benign findings.(b)(6) 2007: the patient was admitted with the following diagnosis: l5-s1 spondylolisthesis with severe lumbar stenosis with low back pain and lumbar radiculopathy.He underwent the following procedures: 1.Lumbar laminectomy with removal of lamina, pars and abnormal facets at l5, the gill procedure.2.Posterior lumbar interbody fusion at t5-s1.3.Posterior lateral fusion, l4-l5, l5-s1.4.Posterior segmental instrumentation.5.The use of intervertebral peek spacer with rhbmp2/acs.6.Harvesting of local autograft.Per op notes, once the end plates of l5 and s1 were decorticated to bleeding bony surfaces, a 10 mm peek cage was taken.This was packed with a collagen sponge soaked in rhbmp2/acs.This was impacted into an appropriate position.The remainder of the disk space was filled with locally harvested autograft that had been morselized.Once interbody fusion was performed, attention was turned to the lateral transverse fusion.The tps of l4, l5 and the top of the ala were decorticated bilaterally.The remainder of the rh-bmp2/acs was taken and placed in direct contact with the bleeding bony surfaces and then a large amount of locally harvested autograft that had been cleaned to soft tissue and run through the bone mill in direct contact again with these bleeding bony surfaces was put bilater ally.Once lateral inter transverse fusion was performed, the rod was placed on the other side.X-ray was performed.It became obvious that l5 screw was not angled to surgeon's liking.This screw was removed on the left and replaced it at a better angle.Another x-ray confirmed exceptional positioning of all of the screws.There was excellent reduction of her spondylolisthesis back down to a grade 1 of 4 to 5mm.No patient complications were reported.(b)(6) 2007: the patient was discharged with the following diagnoses: 1.Status post l4-s1 posterior laminectomy and interbody fusion.2.L5-s1 spondylolisthesis.(b)(6) 2007: thepatient was admitted with the following diagnosis: 1.Lower extremity edema.2.Possible wound infection.Doppler ultrasound of her lower extremities was negative.X-rays of the abdomen and chest were also done, which were negative.(b)(6) 2007: the patient was discharged with the following diagnosis: lower extremity edema, etiology unknown.(b)(6) 2007: the patient presented for a follow-up visit with lower extremity neuropathic symptoms.These involved her entire foot from about the mid portion of the foot out to her toes.This bothered her most at night.She underwent x-rays which revealed good placement of all the hardware; some lateral bone growth; still not a ton of growth in the interspace.(b)(6) 2007: the patient called and complained of burning with urination.She also complained of continued burning of feet.Dosage of lyrica was increased from mg bid to 150 mg bid.(b)(6) 2007: the patient called and reported of continued leg pain.(b)(6) 2011, (b)(6) 2011: the patient presented for a follow-up on insomnia.She had complaints of numbness/tingling in right hand and right forearm, depression and sweats on head for no reason.Dosage of trazodone was decreased from 100mg to 50mg.(b)(6) 2011: the patient underwent x-rays of the chest due to chest pain.Impression: 1.Slight bibasilar atelectasis or scarring.I nfiltrate is felt to be less likely.2.Aortic atherosclerosis.(b)(6) 2011: the patient underwent dxa bone densitometry examination.(b)(6) 2011: the patient presented with chest pain.The patient underwent the following procedures: 1) left heart catheterization.2) left ventriculogram.3) coronary angiogram.4) placement of catheters, supervision and interpretation.Conclusion: 1) normal lv ef of73%.2) normal systemic pressures.3) normal lv edp.4) no mitral regurgitation.5) no aortic stenosis.6) mild coronary artery disease only.(b)(6) 2011: the patient presented with knot on right leg.Assessment: cramp of limb; reaction to chronic stress; muscle hematoma.(b)(6) 2011: the patient underwent cta aorta with runoffs due to right sided claudication.Impression: 1.Moderate focal stenosis of the proximal right common iliac artery over a short segment appears very similar or mildly progressed from 2009 study.2.Confined extraluminal contrast anterior to the right common femoral artery which is suspicious for a pseudoaneurysm if patient has had recent instrumentation.3.Short segment high-grade stenosis of the right common femoral artery.4.Markedly narrowed proximal right superficial femoral artery.5.Remaining mid and distal superficial femoral artery and popliteal artery on the right are patent with patent left lower extremity arterial study.She also underwent duplex lower arteries ltd due to right leg pain.Impression: no focal high-grade stenosis or occlusion identified.There is aneurysmal dilatation involving the distal right common femoral artery measuring 15 x 18 mm.Right leg ultrasound peripheral venous doppler was also done due to right leg pain.Impression: right leg negative for dvt.(b)(6) 2011: the patient presented with right lower extremity ischemia.She underwent peripheral angiography.Conclusion: 1) unsuccessful attempt for left femoral access using micropuncture technique and site rite without complications.(b)(6) 2011: the patient presented with peripheral vascular disease.She underwent brachial approach angiography.Impression: 1) bilateral obstructive common femoral artery stcnoses with a seudoaneurysm in the right common femoral artery.2) three vessel run-off bilaterally.(b)(6) 2012: the patient presented with rash on groin area.Assessment: polyneuropathy - chronic pain; candidal intertrigo.(b)(6) 2012: the patient presented with rash on right arm and middle abdomen.It was accompanied by itching, numbness, tingling, pain in feet and legs.The burning in her feet was worse.Assessment: gastritis; chronic pain; peripheral neuropathy.(b)(6) 2013: the patient underwent pet ct fusion whole body scan.Impression: 1.No evidence of abnormal fdg avidity to suggest residual or recurrent disease.2.Post-therapeutic changes on the right consistent with prior surgery with low-level uptake along the po sterolateral chest wall similar to prior study.3.Interval decrease in noticeable fog avidity in the region of the rectum (significantly less than prior exam).4.Prior cholecystectomy.5.Postsurgical changes of the lumbar spine.6.Cardiac enlargement.(b)(6) 2013: the patient underwent mri of lower extremity joint due to persistent pain.Impression: 1.Tricompartmental chondromalacia with suprapatellar joint effusion.Subchondral cysts are noted in the posterior aspect of the medial femoral condyle and there is mild marrow edema in the medial tibial plateau, both of which are likely related to degenerative changes.2.Possible tearing involving the posterior horn of the medial meniscus.(b)(6) 2012: the patient presented for follow-up for yearly breast examination.Assessment: breast disorders; anxiety disorders.(b)(6) 2012: the patient underwent mammogram screening direct digital image bilateral, routine screening.Impression: benign findings.Birads 2.Benign-type calcification bilaterally.(b)(6) 2012: the patient presented underwent 2d echocardiogram and color doppler.Impression: 1.Overall, there is normal left ventricular size.Systolic dysfunction is normal.Ef is 60%.2.Trace mitral and trace tricuspid regurgitations.3.This is a technically difficult study.Endocardium and valvular structures are not clearly visible.(b)(6) 2012: the patient presented with the following pre-operative diagnosis: right lung nodule.She underwent the following procedure: right thoracotomy with wedge biopsy of the superior segment of the right lower lobe, right lower lobectomy and rnediastinal node dissection.There were no complications.She had the following postoperative diagnosis: non-small cell lung carcinoma.(b)(6) 2012: the patient presented with chronic back pain and neuropathy.Assessment: osteoarthritis of the knee; herniated interver tebral disc; neuropathy secondary to back surgery.(b)(6) 2012: the patient presented with bilateral knee pain.Assessment: arthritis knee, bilateral; right knee with bursitis.(b)(6) 2012: the patient presented with increased edema to bilateral feet.(b)(6) 2012: the patient presented for follow-up.Assessment: localized osteoarthritis of the knee -bilateral.(b)(6) 2013: the patient presented for follow-up visit regarding hypertension.(b)(6) 2013: the patient presented with non-small cell lung cancer.She had worsening breathing during the visit.Impression: early stage of lung cancer.(b)(6) 2013: the patient presented for an office visit to seek clearance for left knee surgery.Assessment: osteoarthritis.(b)(6) 2013: the patient presented with rash in back, buttocks, and abdomen.Assessment: generalized dermatitis; upper respiratory i nfection.(b)(6) 2013: the patient presented for follow-up regarding hypertension.She also had complaints with pain in feet.Assessment: hypertension; herniated intervertebral disc.(b)(6) 2013: the patient presented regarding cta of abdominal aorta with runoff.(b)(6) 2013: the patient presented with follow-up with blood work for cardiologist for diabetes.Assessment: peripheral arterial disease; idiopathic progressive polyneuropathy.(b)(6) 2013: the patient presented for follow-up regarding hypertension.Assessment: hypertension; trigger finger of the right middle finger.(b)(6) 2013: the patient presented with pain in right wrist/hand.Assessment: de quervain's tenosynovitis; herniated intervertebral disc.(b)(6) 2014: the patient presented for follow-up regarding hypertension.She had a lump under the skin of her forehead.Assessment: hypertension; urinary tract infection; chronic pain; peripheral neuropathy; persistent insomnia.

• 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: 5059653
• MDR Text Key: 25111097
• Report Number: 1030489-2015-02220
• 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: 08/11/2015

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 Date: 10/01/2009
• Device Catalogue Number: 7510200
• Device Lot Number: M110602AAH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2006
• 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: 71