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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Headache (1880); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Tinnitus (2103); Vomiting (2144); Weakness (2145); Cramp(s) (2193); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Numbness (2415); Choking (2464); Sleep Dysfunction (2517); Dysuria (2684)
Event Type  Injury  
Manufacturer Narrative
(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) 2009: patient underwent discectomy, fusion and plate placement for herniated l4-5, other discs.Patient was implanted with rhbmp-2/acs.On (b)(6) 2009: patient presented for a consultation visit.Patient complains of pain, both legs getting numb (left worse).His right shoulder hurts when he lies on it.Has occasional falls.Patient had right shoulder injury 5 years ago and a car injury (1991).Impressions: chronic back pain, essential hypertension, copd.On (b)(6) 2009: patient presented for an office visit for follow up on back pain.Patient had a recent fall and complains of pain going down left leg and weakness since the fall.Patient complains of sleep disturbances due to pain.Patient uses a walker to get around.Impressions: chronic back pain, gerd.On (b)(6) 2009: patient presented for an office visit to have a flu shot of fluvax at left deltoid.On (b)(6) 2009: patient presented for an office visit to discuss medications (valium and duragesic).Patient complains of flu, nausea, vomiting.Impressions: nausea, acute sinusitis, chronic back pain, anxiety.On (b)(6) 2012: patient presented for office visit for medication discussion.Patient complains of bloating, indigestion, chronic back and shoulder pain, sinus issues.Patient complains that if he has pressure on his neck he goes numb all over his body.Physical examination reveals pain with chest adduction bilateral shoulders, right shoulder with reduce/painful abduction.Locates pain to low back overlying old surgical scars and wears back support with adjustable straps.Impressions: essential hypertension, gerd, chronic back pain, erectile dysfunction.On (b)(6) 2012: patient presented for a follow up visit.Patient complains of shortness of breath and chest discomfort.Impressions: chest pain, chronic back pain.On (b)(6) 2012: patient underwent mri of lumbar spine without contrast.Indication: backache.Impression: postsurgical changes of l4-l5 posterior fusion construct as above without complicating features.Mild inferior bilateral neural foraminal narrowing at l2-l3 secondary to facet arthrosis and annular disc bulge.Multi-level bilateral facet arthrosis.On (b)(6) 2012: patient presented for a follow up visit on back and shoulder pain.He had mri with some neuroforminal stenosis.On (b)(6) 2012: patient presented for an initial consultation and complains of severe left shoulder pain and limited range of motion due to an injury caused by moving a heavy piece of equipment about 4-5 years ago.Assessment: rotator cuff syndrome and possible rotator cuff tear left shoulder with associated sub acromial bursitis.Impressions: shoulder pain, rotator cuff syndrome and allied d/o.On (b)(6) 2012: patient presented for an office visit due to headache.The location of the headaches is bilateral.The headaches are associated with nausea, photophobia, and phonophobia.Patient underwent mri of left shoulder joint.Impression: partial to complete peripheral non displaced tear of the left rotator cuff with a trace of fluid in the sub-acromial bursa.On (b)(6) 2012: patient presented for follow up on mri for left shoulder.Patient complains of severe pain in bilateral shoulders.Review of systems reveals copd, hypertension, joint swelling depression and weakness.On (b)(6) 2012: patient presented with following pre-operative diagnosis: rotator cuff tear and impingement syndrome of the left shoulder and underwent repair of rotator cuff tear and correction of impingement syndrome left shoulder with distal claviculectomy, sub acromionectomy and resection of the coracoacromial alignment.On (b)(6) 2012: patient presented for a post-operative follow up visit due to left rcr.Patient complains of severe pain and nausea.There is mild swelling about the incision.Assessment: s/p rotator cuff repair with correction of impingement syndrome (dos: (b)(6) 2012).Impressions: shoulder pain, rotator cuff syndrome and allied d/o.On (b)(6) 2012: patient presented for an office visit and complains of many problems due to lab work.Impressions: benign hypertension, mixed hyperlipidemia, arthritis, ddd,gerd, depression, hiatal hernia, allergic rhinitis due to other allergen, fh colon cancer, family history of ischemic heart disease, anxiety, screening psa.On (b)(6) 2012: patient presented to get a cpe, x-ray and ekg done.Impressions: benign hypertension, mixed hyperlipidemia, arthritis, ddd, gerd, anxiety, hiatal hernia.On (b)(6) 2012: patient presented for an office visit and complains that he can锠take prevacid as it is vomiting blood.Patient also complains of indigestion, and abdominal bloating.Impressions: gerd, hemoptysis unspecified, benign hypertension, fh colon cancer, ddd, lung nodule, hiatal hernia.On (b)(6) 2012: patient presented for an office visit.On (b)(6) 2012: patient presented for an office visit for follow up on his egd and colonoscopy.Patient complaints of bilateral shoulder pain, gerd, hypertension, arthritis and back pain.Impression: lumbar back pain with radiculopathy, gerd, erectile dysfunction, benign hypertension, mixed hyperlipidemia, herniated lumbar disk with radiculopathy, arthritis, ddd, and anxiety.Patient underwent thorax w/o -ct due to history of copd, asthma.Impression: moderate coronary artery disease.Mild emphysematous changes to the chest.On (b)(6) 2012: patient presented for office visit due to chief complaint of chest pain.Patient says that he was told to see a heart doctor because his ct shows a blockage.Musculoskeletal examination reveals chronic back pain with reduced rom.Severe tenderness noted on right low back and hip area.Patient complains of shortness of breath and chest discomfort.Impression: cad, shortness of breath, mixed hyperlipidemia, benign hypertension, herniated lumbar disk with radiculopathy ,arthritis, ddd.On (b)(6) 2012: patient presented for chief complaint of substernal chest pressure with exertion.On (b)(6) 2012: patient presented for an office visit due to back pain and hip pain.Musculoskeletal examination reveals chronic back pain with reduced rom.Severe tenderness noted on right low back and hip area.Impressions: arthritis, hip pain, back pain, bilateral shoulder pain, herniated lumbar disk with radiculopathy, lumbar back pain with radiculopathy.On (b)(6) 2012: patient presented for follow up on back and pelvic pain.Impressions: lumbar back pain with radiculopathy, herniated lumbar disk with radiculopathy, bilateral shoulder pain, ddd, arthritis, benign hypertension.On (b)(6) 2012: patient presented for an office visit due to complains of joint pain, back pain, arthritis, stiffness, muscle weakness, loss of strength ,muscle aches, indigestion, nausea and vomiting.Impressions: abdominal pain, gerd, cad, arthritis, benign hypertension, hiatal hernia, herniated lumbar disk with radiculopathy.On (b)(6) 2012: patient presented for face to face evaluation for power scooter.Patient complains of fatigue, shortness of breath, joint pain, back pain, stiffness, and arthritis, loss of strength and muscle aches.Impressions: herniated lumbar disk with radiculopathy, lumbar back pain with radiculopathy, copd, cad, arthritis, ddd, gerd, benign hypertension, mixed hyperlipidemia.On (b)(6) 2012: patient complains that his right leg gave out and he fell off.Patient complains of shortness of breath, cough, muscle cramps, joint pain, back pain and muscle aches.Impressions: herniated lumbar disk with radiculopathy, lumbar back pain with radiculopathy, copd, gerd, benign hypertension.On (b)(6) 2012: patient underwent mri of lumbar spine without contrast due to backache.Impression: no significant interval change.Postsurgical changes of posterior lumbar inter body fusion l4-5 without spinal canal stenosis.There is mild left neural foramina 1 narrowing.Multilevel facet arthropathy, worse at l2-3 and l3-4, to a mild to moderate degree.On (b)(6) 2012: patient presented for a visit due to back pain and mri results.Complains of joint pain, back pain and arthritis.Impressions: herniated lumbar disk with radiculopathy, lumbar back pain with radiculopathy, copd, arthritis, benign hypertension, mixed hyperlipidemia.On (b)(6) 2012: patient presented for an office visit due to office visit which is choking him at night.Musculoskeletal examination reveals chronic back pain with reduced rom.Severe tenderness noted on right low back and hip area.Impressions: gerd, hiatal hernia, copd, herniated lumbar disk with radiculopathy, arthritis, and degenerative disc disease.On (b)(6) 2012: patient presented for office visit for med refill and complains of joint and back pain.Impressions: copd, cad, gerd, benign hypertension, testicular hypofunction.On (b)(6) 2012: patient complains that he has been bloated (abdominal) and having indigestion.Patient complains of back pain, stiffness and arthritis.Impressions: gerd,copd, herniated lumbar disk with radiculopathy, lumbar back pain with radiculopathy, benign hypertension, mixed hyperlipidemia.On (b)(6) 2012: patient presented for an office visit due to headache.On (b)(6) 2013: patient presented for office visit due to shortness of breath, cough and ear cleaning.Impressions: copd, cad, gerd, benign hypertension, ddd.On (b)(6) 2013: patient underwent power mobility device evaluation.Cervical: painful rom in all ranges with crepitus.Lumbar: functional scoliosis from weakness and gait pattern limited and painful mobility in all ranges.Patient has had difficulty with grip strength.Assessment summary: patient presented to the clinic with decreased strength, decreased mobility, decreased balance, decreased cardiovascular endurance and poor/unsafe gait pattern.He has a history of frequent falls; he is unable to ambulate or stand for a prolonged period of time and requires assist with bathing/adl's.He will benefit prom a power mobility device within the home to assist with energy conservation , increased independence within the home, to reduce the risk of falls, to reduce pain and to improve his overall quality of life.On (b)(6) 2013: patient presented for office visit.Per face to face examination report, following complications were noted: shortness of breath with exertion, upper and lower body pain and weakness.Due to abnormality of gait, fatigue, shortness of breath, pain patient is unable to do activities of daily living.Patient complains of joint pain, back pain, muscle weakness, arthritis, and loss of strength, poor balance and weakness.Impressions: herniated lumbar disk with radiculopathy, copd, cad, mixed hyperlipidemia, arthritis, degenerative disc disease, benign hypertension.On (b)(6) 2013: patient presented with preoperative diagnosis of recurrent chest pain and dyspnea, multiple risk factors for coronary artery disease, possible acute coronary syndrome and underwent left heart catheterization, coronary angiography and left ventriculography.On (b)(6) 2013: patient presented for an office visit due to follow up on angiogram test result.Complains of shortness of breath, joint pain, back pain and arthritis.Impressions: copd, herniated lumbar disk with radiculopathy, mixed hyperlipidemia, gerd, benign hypertension.On (b)(6) 2013: patient presented for an office visit due to follow up on hypertension and arthritis.Patient has sore throat and hoarse voice and complains of increased stress and nerves getting worse.Complains of anxiety and depression.Impressions: copd, benign hypertension, arthritis, depression.On (b)(6) 2013: patient presented for follow up on hypertension, arthritis and depression.Patient is having burning with urination.Patient complains of right lower abdomen pain, dysuria, urinary frequency, urinary hesitancy and shortness of breath.Musculoskeletal examination reveals chronic back pain with reduced rom.Severe tenderness noted on right low back and hip area.Impressions: copd, dysuria, exposure to sexually transmitted disease, depression, cad, herniated lumbar disk with radiculopathy, arthritis, gerd, benign hypertension.On (b)(6) 2013: patient presented for office visit due to arthritis pain worsening in knees, arms, shoulders, hands, wrists, hypertension and hearing loss.Patient complains of joint pain, stiffness, and arthritis.Impressions: hypertension benign, ddd, arthritis, decreased hearing, cad, mixed hyperlipidemia.Patient underwent b12 injection due to fatigue at luoqi gluteus.On (b)(6) 2013: patient complained of hearing loss worse on left.He reports intermittent tinnitus in both ears.He does have a history of noise exposure from working as an auto mechanic.The hearing test revealed hearing loss in both ears.It is worse in the right ear.As per audiometry examination, he has a mild sensorineural hearing loss in the left ear and a mild to moderate sensorineural hearing loss in the right ear.On (b)(6) 2013: patient presented for office visit due to back pain and hypertension.Impressions: lumbar back pain with radiculopathy.On (b)(6) 2013: patient presented for an office visit for med refill and back pain.Muscle spasms noted in low back.Impressions: muscle spasm, lumbar back pain with radiculopathy.On (b)(6) 2013: patient presented for an office visit due to pain in legs and feet.Patient complains of muscle cramps, back pain, and muscle aches.Impressions: lumbar back pain with radiculopathy, muscle spasm, copd, mixed hyperlipidemia, cad, arthritis.On (b)(6) 2013: patient presented for an office visit due to shoulder pain.Patient complains of muscle cramps and muscle aches.Impressions: bilateral shoulder pain, benign hypertension, copd, cad.On (b)(6) 2013: patient presented for an office visit due to chief complaint of back pain.The patient complains of musculoskeletal symptoms.Impressions: herniated lumbar disk with radiculopathy, copd, back pain, lumbar, with radiculopathy, special screening malignant neoplasm of prostate, abdominal pain, hypertension benign, gerd.(b)(6) 2013: patient complains of impotency erectile dysfunction.Impression: decreased libido, psychosex dysfunc inhibited excite ,tobacco use disorder.On (b)(6) 2013: patient presented for office visit due to fever, cough.He complains of dyspnea with exertion.Patient complains of fatigue, cough, shortness of breath and wheezing.Impressions: copd, benign hypertension, mixed hyperlipidemia, cough, fever, shortness of breath, bronchitis, allergic rhinitis due to other allergen.On (b)(6) 2013: patient presented for an office visit due to shortness of breath and urinary renal infection.Impression: bronchitis, copd, benign hypertension, shortness of breath.On (b)(6) 2013: patient was admitted.Patient was told to hold his antihypertensive and ultimately went to the emergency room and was told of possible pneumonia and was hospitalized.He states he had a high fever last night.Occasional dyspnea on exertion, fatigue and occasionally feeling weak.On (b)(6) 2013: discharge diagnosis: recent urinary tract infection.Acute renal failure, resolved.Abnormal chest x-ray, resolved.Fever prior to admission, resolved.Mild diastolic dysfunction.Hypertension; tobacco use.Per progress notes".Dr.(b)(6) feels that the renal failure and fever and rash were most likely related to a reaction to the bactrim.".
 
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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 Key5060384
MDR Text Key25217552
Report Number1030489-2015-02227
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
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/08/2015
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 Number1
Patient Outcome(s) Other;
Patient Weight102
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