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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 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Arthritis (1723); Asthma (1726); Bronchitis (1752); Edema (1820); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Pneumonia (2011); Swelling (2091); Weakness (2145); Tingling (2171); Hernia (2240); Stenosis (2263); Anxiety (2328); Joint Swelling (2356); Depression (2361); Sore Throat (2396); Numbness (2415); Respiratory Tract Infection (2420); Neck Pain (2433); Breast Mass (2439); Nasal Obstruction (2466)
Event Type  Injury  
Manufacturer Narrative
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.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported per patient¿s medical records that on: (b)(6) 2003: the patient was admitted with the following pre-operative diagnoses: discogenic disc disease; discogenic lower back pain; lumbar radiculopathy right l4 to l5.She underwent the following procedures: lamina foraminotmy l4-5 right, l5-s1 right; lumbar hemilaminectomy right l4-5; lumbar hemilaminectomy right l5-s1; lumbar arthrodesis, l4 to s1; instrumented lumbar segmental fusion, pedicle screws at l4, l5 and s1, m8; aspirin of iliac crest bone marrow for fusion.The following implants were used: allomatrix custom times two with vancomyci, large and m8 screws.Per op notes, ¿¿ facetectomies were performed at l4-5 and l5-s1 to allow adequate visualization of the exiting nerve roots at l4 and l5.The aspiration of the iliac crest site was done with a jamshidi needle to obtain bone marrow for effusion.This blood was then mixed with allomatrix custom and vancomycin, and then placed into an rhbmp-2 sponge.Our pedicle screws were placed with visualization on the right side of the pedicle, as well as intraoperative radiographs.Our pedicles were tested using emg testing, neurophysiologic monitoring and all were well above threshold.After placement of all of our hardware, the decorticated transverse processes were then packed with allomatrix custom and rhbmp-2 bone products¿¿ no patient complications were reported.On (b)(6) 2003: the patient underwent physical therapy.On (b)(6) 2003: the patient was discharged.On (b)(6) 2003: the patient underwent x-rays of the lumbar spine.Impression: posterior spinal fusion with instrumentation l4 to s1, wi thout significant change in alignment; there was disc space narrowing at l5-s1.On (b)(6) 2003: the patient presented with persistent low back pain and right sciatica.On (b)(6) 2003: the patient underwent x-rays of the chest due to bronchitis and dyspnea.Impression: normal chest.She also underwent x-rays of the lumbar spine.Impression: status post l4 to s1 posterior spinal fusion with instrumentation in expected position.On (b)(6) 2004: the patient presented with low back pain and right sciatica.On (b)(6) 2004: the patient underwent x-rays of the lumbar spine.Impression: impression: prior posterior spinal fusion procedure with instrumentation and partial l5 laminectomy, with no evidence of failure.On (b)(6) 2004: the patient presented with chronic low back pain.On (b)(6) 2004: the patient underwent ct of lumbar spine due to prior spinal fusion.Impression: posterior spinal fusion with instru mentation at l4, l5 and s1, with no evidence of hardware loosening; posterolateral bone graft has not yet fused; mild degenerative disc disease at l4-5 with severe degenerative disease at l5-s1 with vacuum phenomenon and mild disc bulge but no canal stenosis.On (b)(6) 2005: the patient presented for follow-up of chronic medical problems.She had some back pain.On (b)(6) 2005: the patient presented with follow-up of pneumonia and chronic medical problems (hypertension, chronic obstructive pulmonary disease and depression).On (b)(6) 2005: the patient called and complained of cough.On (b)(6) 2005: the patient presented with lower abdominal pain with cough.She had a history of hernia in gallbladder surgery scar which was incarcerated; she was worried about the same scar.On (b)(6) 2005: the patient presented for follow-up of recent illness.On (b)(6) 2005: the patient presented for follow-up of pneumonia.She also had some chest heaviness.On (b)(6) 2005: the patient presented for follow-up of fever.On (b)(6) 2005: the patient presented with sinus congestion.She had chest congestion and tightness.On (b)(6) 2005: the patient presented for follow-up of bronchitis.On (b)(6) 2005: the patient presented for follow-up of bronchitis/ chronic obstructive pulmonary disease.She also complained of ear pain and occasional coughing problems.On (b)(6) 2006: the patient presented with productive cough, mid head congestion.On (b)(6) 2006: the patient presented for follow-up of hypertension, chronic obstructive pulmonary disease, and chronic pain.On (b)(6) 2006: the patient presented for follow-up of chronic obstructive disease and she also felt some pain in her legs.On (b)(6) 2006: the patient called and reported that her legs were swollen.On (b)(6) 2006: the patient presented for a follow-up of hypertension, hyperlipidemia, chronic obstructive pulmonary disease, glucose i ntolerance, and chronic low back pain.On (b)(6) 2006: the patient presented with 3 day history of deep nonproductive coughing, fever, chills, and shortness of breath.On (b)(6) 2006: the patient called and reported of sinus problems.On (b)(6) 2006: the patient presented with mild edema all over.Assessment: edema, likely fluid retention.On (b)(6) 2006: the patient presented with sore throat, laryngitis.On (b)(6) 2006: the patient presented with voice problems, soreness in throat, head congestion, sinus, and headache.Assessment: upper respiratory infection, possible sinusitis.On (b)(6) 2006: the patient presented for follow-up of hypertension, coronary artery disease, hyperlipidemia, chronic obstructive pulmonary disease and chronic low back pain.On (b)(6) 2007: the patient presented with cough, shortness of breath.Cough was produced of yellow phlegm.On (b)(6) 2007: the patient presented for a follow-up of hypertension, chronic low back pain, coronary artery disease, hyp erlipidemia, chronic obstructive pulmonary disease, and glucose intolerance.On (b)(6) 2007: the patient presented with swelling in legs and ankles.On (b)(6) 2007: the patient presented for follow-up of low back pain, hypertension, coronary artery disease, hyperlipidemia and depression.On (b)(6) 2007: the patient called and complained of bronchitis and congestion.On (b)(6) 2007: the patient presented with hurt tailbone.She slipped on the ice.Assessment: low back pain and hypertension.On (b)(6) 2008: the patient presented for a follow-up of hypertension, hyperlipidemia, coronary artery disease, depression, glucose intolerance and chronic low back pain.On (b)(6) 2008: the patient presented for a follow-up of hypertension, chronic low back pain, hyperlipidemia, chronic obstructive pulmonary disease and depression.On (b)(6) 2008: the patient presented with anxiety.On (b)(6) 2008: the patient presented with hypertension.On (b)(6) 2008: the patient presented for an office visit.She was diagnosed for posterior neck pain and headache.On (b)(6) 2009: the patient presented with fatigue and insomnia.On (b)(6) 2009: the patient presented with right leg weakness.She was also diagnosed with possible hernia.On (b)(6) 2009: the patient underwent x-rays of right knee due to joint pain.Conclusion: no fracture demonstrated.On (b)(6) 2009: the patient presented for an office visit.She presented regarding hernia repair.On (b)(6) 2009: the patient underwent bilateral diagnostic digital mammogram due to new palpable lump in right breast.Impression: negative bilateral diagnostic mammogram.On (b)(6) 2009: the patient presented for an office visit.She was diagnosed for hypertension.Oin (b)(6) 2009: the patient presented with a lump or mass in breast.On (b)(6) 2009: the patient presented for biopsy.On (b)(6) 2009: the patient presented for an office visit.She was diagnosed with depression, chronic low back pain, fatigue, and leg pain.On (b)(6) 2009: the patient presented for biopsy.On (b)(6) 2009: the patient presented for a follow-up with chronic low back pain, hypertension, hyperlipidemia, and glucose intolerance.On (b)(6) 2009: the patient presented with emesis, chills, fever, and immunizations/injections.She was also diagnosed with bronchitis and chronic obstructive pulmonary disease.On (b)(6) 2009: the patient presented for an office visit.She was diagnosed with hypertension, chronic low back pain.On (b)(6) 2009: the patient presented with joint swelling and cough.She was also diagnosed with knee pain and bronchitis.On (b)(6) 2010: the patient presented with fever, chills and excessive thirst.On (b)(6) 2010: the patient presented with follow-up of sinus problems.She complained of chest congestion, fever, shortness of breath, and wheezing.She was also diagnosed with chronic low back pain.On (b)(6) 2010: the patient presented with knee pain and joint swelling.She was also diagnosed with chronic low back pain.On (b)(6) 2010: the patient presented for an office visit.On (b)(6) 2010: the patient presented for a follow-up of hypertension.She also had her medications refilled.She was also diagnosed with anxiety, chronic low back pain, allergic rhinitis, asthma, and gastroesophageal reflux disease.On (b)(6) 2010: the patient presented with follow-up of back pain.She was also diagnosed with hypertension and anxiety.On (b)(6) 2011: the patient presented with the upper respiratory infection.She complained of bad cough problems, which prevented to sleep.She also reported fever.On (b)(6) 2011: the patient presented with yeast infection.She reported that she had thrush in her mouth caused by her inhalers.On (b)(6) 2011: the patient presented with pneumonia.On (b)(6) 2011: the patient presented for an office visit.On (b)(6) 2011: the patient presented for follow-up of pneumonia.On (b)(6) 2011: the patient presented with follow-up of hypertension.She was also diagnosed for chronic obstructive pulmonary disease and coronary artery disease.She complained of pain in upper back, and swelling in legs in hot and humid weather.On (b)(6) 2011: the patient presented with hypertension.She was also diagnosed with chronic low back pain, osteoarthritis and hyperlipidemia.On (b)(6) 2011: the patient presented for an office visit for medication query.On (b)(6) 2011: the patient presented with follow-up of back pain.She also complained of pain in legs and feet.Her problems also included shortness of breath, coughing up sputum, and hoarseness.On (b)(6) 2011: the patient presented for an office visit.She was diagnosed with unspecified hypothyroidism.On (b)(6) 2011: the patient presented for screening of colon cancer.The patient¿s colonoscopy could not be done because her intestines were twisted.On (b)(6) 2012: the patient presented with sinusitis.She had a 6 day history of cough, congestion and fever.Assessment: pneumonia, organism unspecified; anxiety; chronic low back pain; unspecified hypothyroidism; allergic rhinitis, cause unspecified; coronary artery disease.On (b)(6) 2012: the patient presented with chronic low back pain.On (b)(6) 2012: the patient presented for a follow-up of shortness of breath.On (b)(6) 2012: the patient presented for medication refill.Physical examination also revealed new muscle pains, joint pain, joint swelling and numbness.On (b)(6) 2012: the patient presented for medication refill.She complained of low back pain and swelling in legs and feet due to a lot of walking.On (b)(6) 2012: the patient underwent mri of lumbar spine due to back pain.Summary: post-operative fusion of l4-l5 and l5-s1 disc spaces with a left paracentral herniation at l5-s1 with right lateral recess stenosis at the same level.On (b)(6) 2012: the patient presented with chronic low back pain.She also complained of paresthesias in right leg and weakness in right leg.Assessment: unspecified hypothyroidism; chronic low back pain; tobacco abuse.On (b)(6) 2012: the patient presented for medication refill.She also complained of swelling in both legs.Assessment: edema; hyp othyroidism; spinal stenosis of lumbosacral region; chronic low back pain.On (b)(6) 2013: the patient presented with chronic low back pain.Assessment: chronic low back pain; elevated ¿lfts¿; gastroes ophageal reflux disease; coronary artery disease; hyperlipidemia.On (b)(6) 2013: the patient presented with the following diagnoses: chronic low back pain; depression; recurrent knee pain.On (b)(6) 2013: the patient underwent mri of right knee due to pain.Impression: multiple subchondral changes affect the articular surface of the femoral condyles and lateral margin of the patella; degenerative tear of the posterior horn of the lateral meniscus.On (b)(6) 2013: the patient presented with the following diagnoses: failed back syndrome, spinal stenosis of lumbosacral region, chronic low back pain.On (b)(6) 2013: the patient presented with the following diagnoses: chronic low back pain, spinal stenosis of lumbosacral region, right knee meniscal tear.On (b)(6) 2013: the patient presented with low back pain.Assessment: osteoarthritis; chronic low back pain; failed back syndrome; screening of breast cancer.On (b)(6) 2013: the patient presented for medication management.On (b)(6) 2013: the patient presented with hypertension and cough.On (b)(6) 2014: the patient presented for follow-up of hypertension.She was also diagnosed for upper respiratory infection, hoarse, fever, sob, sinus pain.Assessment: upper respiratory infection; arthritis of both knees; chronic low back pain; spinal stenosis of lumbosacral region; hypertension; impaired glucose tolerance.On (b)(6) 2014: the patient presented with hypertension and for medication refill.She also complained of numbness and tingling in arms, and low back pain.On (b)(6) 2014: the patient presented for follow-up, and was diagnosed for: arthritis of both knees; chronic low back pain; spinal stenosis of lumbosacral region; stress reaction.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5594218
MDR Text Key43211380
Report Number1030489-2016-01153
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
Report Date 03/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510800
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/25/2016
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 Number1
Patient Outcome(s) Other;
Patient Weight94
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