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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 Fatigue (1849); High Blood Pressure/ Hypertension (1908); Muscle Weakness (1967); Weakness (2145); Stenosis (2263); Joint Swelling (2356); Neck Pain (2433); Sleep Dysfunction (2517)
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.
 
Event Description
It was reported that on (b)(6) 2006: the patient presented with pain indicated mild degenerative changes were noted at l3-4, l4-5.A compression deformity was not present.Development was normal.The oblique views were normal.Impression: 1.Mild degenerative changes.2.No evidence of a fracture deformity.(b)(6) 2006: the patient underwent uncomplicated anterior lumbar fusion, l5, s1.His postop course was uncomplicated.His neurovascular examination remained intact throughout his postop course and he was demonstrating independent control of his bowels and bladder at the time of discharge.He had positive discography.Because of continued pain complaints, failure or injections, physical therapy, due to which an anterior fusion at al5-s1 was recommended.Preop diagnosis: discogenic pain l5-s1.The patient had undergone 1.L5-s1 completed diskectomy with decompression.2.L5+s1 anterior lumbar interbody fusion.3.Insertion of prosthetic spacer l5-s1 with bmp.4.L5- s1 anterior lumbar plating, 5.Fluoroscopic guidance for insertion of instruments.The patient was implanted with alif spacer from synthes was then placed under fluoroscopic guidance.Pbx along with bmp was placed around the graft and the distraction was removed.An anterior lumbosacral plate was affixed to the spine with two screws in l5 two screws in s1.All screws were tightened down so they engaged locking mechanism on the plate.Ap lateral fluoroscopic images were obtained finally at the conclusion of the procedure after the retractors were removed confirming proper positioning of the instrumentation and correct level of surgery.The following implants were also used in the surgery dbx mix 5cc and alif spacer, anerior 17mm from musculoskeletal transplant foundation.(b)(6) 2006: patient presented for refill on his pain medication.(b)(6) 2006: patient presented for refill on his sleeping medication.(b)(6) 2006: patient presented for x-ray report: ap and lateral lumbar spine images show an anterior lumbar plate and graft at the ls-s1 level.The graft appears to be in good position; there was no loosening about the instrumentation.Impression: healing lumbar spine fusion.Physical examination revealed that his neurovascular examination was intact.His x-rays looked good.(b)(6) 2006: patient presented for x-ray report ap and lateral lumbar spine images show anterior lumbar plate and graft at the l5-s1 level.On ap view, a margin between the graft and l5 host bone.There was no definite loosening about the instrumentation.On the lateral, there was some remodeling of the graft anteriorly.Impression: healing lumbar spine fusion.The patient visited to office for getting narcotic medication.He was having still some back pain and some difficulty sleeping.Physical examination: neurologics are intact.His fusion was not completely healed.(b)(6) 2006: patient presented for office visit and was doing a lot better.He had gotten himself off all medication.He was not using alcohol or any other street drugs now either.He was getting active counseling with regard to that.He had some occasional aching in his back, but overall, he was doing better than prior to the surgery.Physical examination: his neurovascular examination was intact.X-ray: his x-rays looked fine.Ap and lateral lumbar spine images show an anterior lumbar plate and graft at the l5-s1 level.The graft appears to be incorporating.There was loosening about the instrumentation.Impression: healing lumbar spine fusion.(b)(6) 2007: underwent x-ray and reported ap and lateral lumbar spine images show anterior lumbar plate and graft at the l5-s 1 level.The graft appears to be incorporating.There was no loosening about the instrumentation.Impression: healing lumbar spine fusion.(b)(6) 2007: the patient presented for office visit for physical examination he had good range of motion and normal strength and dia gnostic studies: his x-rays looked like he was healing fine.Impression: doing well after anterior lumbar fusion at l5-s1.(b)(6) 2007: the patient presented for office visit and said his skin incision had healed well.Physical examination: neurovascular examination was intact.Diagnostic studies: his ct scan shows a solid fusion.(b)(6) 2009 the patient was presented with leg, groin, buttocks to left mid-thigh; weakness left leg preformed mri, revealed internal fixation of l5 and s1 anteriorly.There was metallic artifact from internal fixating screws.Examination reveals broad-based disk bulging with facet hypertrophy producing moderate central and bilateral lateral stenosis at l3-4 and l4-5.No large focal disk herniation was seen.Vertebral bodies are normally aligned in the lateral view.The bone marrow signal intensity as well preserved.The signal intensity in the spinal canal was normal.Impression: 1.Internal fixation of l5 and s1 with approximate alignment.2.Broad-based disk bulging with facet hypertrophy and thickening of the ligamentum flavum producing moderate central bilateral lateral stenosis at l3-4 and l4-s.3.No large focal disk herniation identified.(b)(6) 2009: patient present for diagnosis of leg, groin, buttock to left mid-thigh, weakness left leg.Magnetic resonance imaging was performed through the lumbar spine using multiple sequence multiplanar techniques.Examination reveals internal fixation of l5 and s1 anteriorly.There was metallic artifact from internal fixating screws.Examination reveals broad-based disk bulging with facet hypertrophy producing moderate central and bilateral lateral stenosis at l3-4 and l4-5.No large focal disk herniation was seen.Vertebral bodies are normally aligned in the lateral view.The bone marrow signal intensity as well preserved.The signal intensity in the spinal canal was normal.Impression: 1.Internal fixation of l5 and s1 with approximate alignment.2.Broad-based disk bulging with facet hypertrophy and thickening of the ligamentum flavum producing moderate central bilateral lateral stenosis at l3-4 and l4-s.3.No large focal disk herniation identified.(b)(6) 2010: the patient presented with skull, routine and had a history of cystic lesion on left occipital area/headache.There was prominence of the external occipital protuberance.Findings are felt to be normal variant.Impression: plain films of the skull negative for obvious focal osseous destructive change or fracture.There was prominence of the posterior occipital protuberance of questionable clinical significance.(b)(6) 2010: the patient was presented for mri scan with leg weakness, numbness; hx previous back surgery; pain since.Findings: the vertebral body height and marrow signal intensity was within normal limits and unchanged allowing for the postoperative changes at l5-s1.The ls-s1 level demonstrates diskectomy with interbody fusion and anterior metallic fusion changes.The conus medullaris was at the t12-l1 level, normal.The t12-l1, ll-2 and l2-3 disk spaces are otherwise normal.The l3-4 level demonstrates mild-moderate diffuse bulging of a degenerative annulus which results in mild central spinal stenosis and mild, left greater than right, neural foraminal stenosis.The l4-s level demonstrates diffuse bulging of a degenerative annulus which contributes to mild central and moderate-severe bilateral neural foraminal stenosis with associated facet hypertrophic changes.Diskectomy with anterior and interbody fusion change are noted at l5-s1; there was no evidence of a recurrent disk or neural foraminal stenosis at this level.Impression: 1.The l4-s level demonstrates moderate bilateral neural foraminal stenosis secondary to a combination of diffuse bulging of a degenerative annulus and facet hypertrophic changes.2.Postoperative changes are noted at l5-s1, stable, without evidence of recurrent disk protrusion.18 oct 2010: patient presented with diagnosis: lumbar disc displacement, lumbosacral spondylolysis w/o myelopathy, back pain/lumbago, lumbar radiculopathy.The patient underwent the procedure for selective nerve root injection left side, under fluoroscopic guidance l3-la-5 left.No complications were reported.Indications: persistent and increasing low back pain with burning in the affected extremity.(b)(6) 2011: the patient have undergone physical examination and found spine was tender at lumbar spine (b)(6) 2011: the patient was presented with chronic low back pain and insomnia.He still unable to sleep due to racy mind at night elavil did not work.No loss of bowel or bladder control.He noticed left side sciatica.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, insomnia nos.(b)(6) 2011: the patient was presented with chronic low back pain and anxiety.He states that his back pain was worse.No loss of bowel or bladder control.He also stated that he cannot sleep with klonopin.He notices left sciatica.(b)(6) 2011: the patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, insomnia nos.(b)(6) 2011: the patient was diagnosed with back pain and anxiety.Had symptoms of fatigue, weakness, unstable walking impaired sleep.(b)(6) 2011: the patient was presented with chronic low back pain.No loss of bowel or bladder control.He had chronic right elbow pain with radiation to right hand.He had weakness right 'hand due to elbow pain.Patient denied any numbness.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.(b)(6) 2011: the patient examined for elbow right- 3 views.Technique: anterior, two oblique and lateral views of the right elbow were obtained.Findings: alignment was normal.No fracture, osteochondral lesion or joint effusion.Tiny marginal osteophyte at the tip of the coronoid with minimal associated ulnohumeral joint space narrowing consistent with minimal osteoarthritis.Small olecranon spurs at the triceps attachment.Soft tissues are unremarkable.Impression: 1.Minimal ulnohumeral osteoarthritis, otherwise negative right elbow.(b)(6) 2011: the patient was presented with low back pain and anxiety.He still had insomnia.Patient continued right elbow pain.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.(b)(6) 2011: the patient was presented with low back pain and anxiety.He stated that notriptyline worked for insomnia.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.(b)(6) 2011: the patient was presented with low back pain and anxiety.No new complaints.Patient undergone physical examination and found tender at lumbar spine.(b)(6) 2011: the patient was presented with low back pain and anxiety.He cannot tolerate nortriptyline due to next day drowsiness.No new complaints.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, generalized anxiety dis, insomnia nos (b)(6) 2011: the patient was presented with low back pain and anxiety.He had insomnia.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, generalized anxiety dis, insomnia nos.(b)(6) 2011: patient returned office for follow-up.He had chronic low back pain and anxiety.Patient denied any complaint.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, generalized anxiety dis, insomnia nos.(b)(6) 2012: patient returned office for follow-up.He had chronic low back pain.No new complaints.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: lumbago, generalized anxiety dis.(b)(6) 2012: patient returned office for follow-up.He had chronic low back pain.No new complaints.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.(b)(6) 2012: patient returned office for follow-up.He had chronic low back pain.He was admitted in hospital for detox he had all medicines except zoloft.(b)(6) 2012: patient returned office for follow-up.He had chronic low back pain and bilateral hand numbness and tingling, worse at night.Patient had chronic depression and anxiety.Patient also complaint new onset of neck pain.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: chronic pain nec, skin sensation disturb, generalized anxiety dis.(b)(6) 2012: patient returned office for follow-up.He had chronic low back pain and had hand numbness and tingling.Patient undergone physical examination and found normal straight leg raise tender at lumbar spine.Impressions: chronic pain nec, depress psychosis-mild, hypertension nos (b)(6) 2012: the patient underwent motor nerve conduction velocity examination.Impression: the findings are consistent with bilateral carpal tunnel syndrome.(b)(6) 2012: patient presented with chronic bilateral hand pain.Patient had neck and low back pain.Patient bp was better.Patient undergone physical examination and found tender at lumbar spine.Impressions: carpal tunnel syndrome, hypertension nos, chronic pain nec.(b)(6) 2012: the patient underwent physical exam of musculoskeletal f lumbar spine having tenders.Comments negative straight leg raise.(b)(6) 2012: patient returned office for follow-up.He had plastic surgery.Patient had chronic low back pain.Patient undergone physical examination and found tender at lumbar spine.Impressions: lumbago, hypertension nos, carpal tunnel syndrome.(b)(6) 2012: patient presented with chronic low back pain and needed refill.He denied any new complaints.Patient undergone physical examination and found tender at lumbar spine.Impressions: lumbago, hypertension nos.(b)(6) 2012, (b)(6) 2013: patient presented with back pain, hypertension and carpal tunnel.He had undergone musculoskeletal joint swelling and muscle, weakness, back pain.(b)(6) 2013, (b)(6) 2014: patient presented with chronic problems lumbago, hypertension, unspecified, carpal tunnel syndrome, dietary surveillance counseling, other and unspecified hyperlipidemia, routine medical exam.Smoking status: former smoker.Alcohol: there was a history of alcohol use.Consumed occasionally.(b)(6) 2013: patient presented with back pain, hypertension, having chronic problems: lumbago, hypertension, unspecified carpal tunnel syndrome, dietary surveillance counseling, other and unspecified hyperlipidemia, routine medical exam.
 
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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 Key5030862
MDR Text Key24050238
Report Number1030489-2015-02095
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 Other
Report Date 07/27/2015
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 Catalogue Number7510400
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/26/2015
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;
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