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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Cyst(s) (1800); Hearing Loss (1882); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Dizziness (2194); Stenosis (2263); Injury (2348); Sore Throat (2396); Neck Pain (2433); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(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 post the first surgery, in which the patient was implanted with rhbmp-2/acs, the patient suffered from progressively worsening in his low back, with associated burning pain and radiculopathy in his lower extremities.He underwent revision surgery due to severe pain and injuries.On (b)(6) 2010, the patient underwent posterior lumbar interbody fusion from vertebrae l3-l4.She was implanted with rhbmp-2/acs.Post the second surgery, the patient suffered from progressively worsening pain in his lower back, with associated pain and radiculopathy in his lower extremities.The patient continues to experience chronic low back pain, with pain and radiculopathy down both legs and into the feet.He cannot sit, stand or walk for any extended period.He cannot work.He is unable to enjoy his daily activities that he enjoyed preoperatively, and has suffered serious and permanent injuries.
 
Manufacturer Narrative
(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 that on (b)(6) 2010, the patient presented to the office with pre-op and post-op diagnosis: mechanical low back pain, lumbar radiculopathy and lumbar fusion, procedure: exploration of previous lumbar fusion of l4 to sacrum, removal of instrumentation followed by decompressive lumbar laminectomy at l3/4 with discectomy cleft and pedicle screw fusion at l3/4.The patient presented with mechanical low back pain and lumbar radiculopathy.Per-op notes: peek material filled with bmp and bone graft were prepared and were placed under fluoroscopic guidance and the spacers countersunk toward the anterior endplate.40 mm rods were used.On (b)(6) 2010, the patient underwent spine lumbosacral due to back pain, impression: stable posterior fusion changes of l4 and l5 with a narrowed and degenerative l6-s1 disc space.Slight anterior wedge deformity of t12, there is arterial sclerosis.On (b)(6) 2010: the patient underwent post op lumbar fusion ls spine xtr.Impression: stable posterior fusion changes of l4 and l5 with a narrowed and degenerative l6- s1 disc space.On (b)(6) 2010, the patient presented to the office for a post-operative visit.On (b)(6) 2010, the patient underwent spine lumbosacral, post-op lumbar fusion, impression: no motion segment instability or hardware loosening, no subluxation.On (b)(6) 2010, the patient presented to the office for follow-up.On (b)(6) 2010, the patient presented to the office reporting that he has burning on the sides of thighs, aching/burning in ankles and knees, achy pain across the back of his feet, difficulty in standing for greater than 2 hours.On (b)(6) 2010, the patient presented to the office due to increased burning in the left hip, knee and ankle.On (b)(6) 2010, the patient presented to the office for follow-up.On (b)(6) 2010: patient presented for office visit with his arm a little stiff.(b)(6) 2010, (b)(6) 2011, (b)(6) 2010, the patient presented for office visit.On (b)(6) 2010, the patient presented for eye check-up due to irritation in eyes.On (b)(6) 2010: the patient presented for lower back surgery and therapy for the same.On (b)(6) 2010: the patient underwent audiometric evaluation.Findings: right -mild to severe sensorineural loss.Left - mild to severe sensorineural loss.On (b)(6) 2010: patient presented for office visit with derm consult.On (b)(6) 2011: patient presented for office visit with back pain.Diagnosis: otitis media, mucoid, chronic, simple or unspecified.Neoplasm of uncertain behavior of larynx.Sinusitis, maxillary, chronic.Patient had a feeling that he has fluid in both ears.On (b)(6) 2011, the patient underwent ct maxillofacial due to sinusitis, impression: nasal septal deviation, no other lesions evident.On (b)(6) 2011: patient under went x-ray with or without contrast.On (b)(6) 2011, the patient underwent ct of neck due to right parotid tumor, impression: multiple enhancing lesions noted both parotid glands.Patient also under went x-ray (two views of the chest).Impressions: no active disease.On (b)(6) 2011: pre-op diagnosis: septal deformity with chronic maxillary and frontal sinusitis with laryngeal cyst and bilateral middle ear effusions.Procedure: septoplasty with nasal endoscopy, balloon-assisted frontal and maxillary sinusotomies with direct laryngoscopy and biopsy of a laryngeal or epiglottic cyst with bilateral tympanostomy with tubes.On (b)(6) 2011: patient presented for office visit for evaluating current physical abilities.Diagnosis: chronic low back pain.On (b)(6) 2011, the patient was presented for foot and ankle pain (b)(6) 2011, the patient underwent extremity arterial ultrasound to assess for pvd, impression: normal bilateral peripheral vascular arterial ultrasound of the lower extremities.(b)(6) 2011: patient visited for follow up post surgery and for ct review.Diagnosis: benign neoplasm of major salivary glands.Surgery follow-up examination.On (b)(6) 2011: pre-op diagnosis: right parotid tumor, probably benign.Post-op diagnosis: probable warthin's tumor based on frozen section.Procedure: excision of right parotid tumor without nerve dissection with nerve monitoring with frozen section.On (b)(6) 2011: the patient was presented with surgery to major salivary gland (b)(6) 2011: the patient called the doctor and asked for pain medicine refill.(b)(6) 2011, the patient underwent x-ray of chest due to cough, impression: there is no acute 9.The patient was presented with cough with yellow green sputum and ankle pain.On (b)(6) 2011: patient presented for office visit to take h<(>&<)>p appointment for surgery.Diagnosis: neoplasm of uncertain behavior of larynx.Eustachian tube, dysfunction of.The patient presented for pre operative diagnosis: probable epiglottic cyst.He underwent direct laryngoscopy with operating microscope with excision of cystic lesion of the laryngeal surface of the epiglottis with cautery of base (b)(6) 2011: pre-op diagnosis: probable epiglottic cyst.Procedure: direct laryngoscopy with operating microscope with excision of cystic lesion of the laryngeal surface of the epiglottis with cautery of base abnormality.On (b)(6) 2011: patient presented for follow up post surgery.Diagnosis: eustachian tube, dysfunction of.Nasal airway obstruction congestion.On (b)(6) 2011, (b)(6) 2012, the patient presented for office visit.On (b)(6) 2012: the patient presented for office visit.On (b)(6) 2012, the patient underwent x-ray of hip due to hip pain, impression: normal study.On (b)(6) 2012, the patient presented to the office due to low back pain and previous surgery, impression: post-operative changes , interval loss of disc space height at l2/l3, consistent with worsened degenerative disc disease.On (b)(6) 2012, the patient presented to the office with chief complaints of dizziness and weakness, impression: no acute intracranial findings, extensive amount of fluid in the bilateral mastoid air cells.On (b)(6) 2012, the patient underwent ct of thorax, impression: mediastinal lymphadenopathy, size makes further categorization equivocal, bilateral hilar soft tissue enlargement, differential: prominent enlarged pulmonary arterial/venous vascular anatomy, occult hilar mass lesions not excludable on non-contrast ct protocol.On (b)(6) 2012, the patient underwent ct of thorax, impression: essentially unremarkable ct, the thorax with intravenous contrast.On (b)(6) 2012: patient presented for office visit for treatment of bcc on his nose.On (b)(6) 2102: patient presented for office visit.On (b)(6) 2012: patient presented for office visit, complaining his ears feels stopped up.The patient suffers with pain-throat, back pain-surgery, hearing loss bilateral, sore-throat-due to surgery and diabetes.Diagnosis: eustachian tube, dysfunction of otitis media, serous, chronic, simple or unspecified.On (b)(6) 2012: patient presented with following discharge diagnosis: dehydration with prerenal failure.Hypophosphatemia.Bilateral hilar fullness on chest x-ray followed up with tomography scan of chest.Chronic back pain.Morbid obesity.Dyslipidemia.On (b)(6) 2012: patient visited for follow up.On (b)(6) 2012: patient presented for office visit, patient underwent orthopedic compensation and pension examination to determine nature and etiology of patient's back disability.On (b)(6) 2012: patient presented for office visit for consultation of chronic rhinitis.On (b)(6) 2012: patient presented for office visit, wanting tubes.Diagnosis: bilateral mixed hearing loss.On (b)(6) 2012: patient visited for follow-up, patient under went ct thorax with contrast.On (b)(6) 2012: patient underwent pulmonary diagnostic intervention procedure.Impression: not obstructive airflow limitation by spirometry.Flow volume loop share is obstructive in configuration.No pulmonary restriction.Diffusion capacity mildly reduced.On (b)(6) 2012: the patient underwent ct scan of lumbar spine.Impressions: postop changes with laminectomy defect and discectomy l3-l4, l4-l5 and l5-s1 levels.Soft tissue attenuation involving the spinal canal extending into the posterior soft tissues l3-l4, l4-l5 and l5-s1 levels probably due to scar tissue from patient's previous surgery.On (b)(6) 2013, the patient presented to the office on referral by the va to discuss a possible neurostimulator, underwent physical examinations.On (b)(6) 2013: the patient underwent mri scan of lumbar spine.Impressions: postop changes with laminectomy defect and pedicle screws l3- l4 level.Postop changes with laminectomy defect at the l4-l5 and 15-sl levels.Mild bulging disc l2- l3 disc.Degenerative arthritis.Lumbar spinal canal stenosis l5-l3 level.Degenerative disc disease of the t10-t11 , l1- l2 through the l5-s1 disc.Degenerative endplate changes involving the l2- l3, l3-l4, l4- l5 and l5-s1 levels.On (b)(6) 2014: the patient underwent radiography of thoracic spine.Findings: there are dorsal column stimulator leads noted overlying the t8-t10 vertebral body levels.No evidence of lead discontinuity or breakage is evident.On (b)(6) 2014, the patient presented to the office for follow-up visit.On (b)(6) 2014, the patient underwent x-ray of chest, impression: non-specific interstitial prominence evident in the lungs bilaterally without focal consolidation or effusion.The patient underwent x-ray of two view chest.The soft tissue appeared within the normal limits.On (b)(6) 2014, the patient presented with pre-op and post-op diagnosis: post laminotomy syndrome, lumbar spine, procedure: placement of a spinal cord stimulator lead and generator using a thoracic laminectomy, injection of local anesthetic for partial relief, fluoroscopy.No complication was reported.On (b)(6) 2014, the patient presented to the office with chief complaint of low back pain.The cardiovascular and respiratory examinations indicated negative for chest pain and negative for dyspnea respectively.On (b)(6) 2014: the patient underwent ct scan (b)(6) 2015: the patient underwent ct scan of abdomen and pelvis with and without contrast.Impressions: post-op changes were noted over the lower lumbar spine.On (b)(6) 2015: patient presented with following principal diagnosis: fracture of l1 vertebra.Secondary diagnosis: atelectasis, postoperative ileus.On (b)(6) 2015.The patient underwent x ray of chest 2 view.Impression: no actuate pulmonary from the prior study.
 
Event Description
It was reported that on: (b)(6) 2010, the patient presented to the office for a post-operative visit.The patient was presented with lumbar fusion, removal of instrumentation and lumbar decompressive laminectomy and plif for follow up and underwent physical examination.On (b)(6) 2010, the patient underwent spine lumbosacral, post-op lumbar fusion, impression: no motion segment instability or hardware loosening, no subluxation.Patient underwent ct scan.Impression: finding suggestive of six lumbar vertebra l6-s1 degenerative disc disease and a questionable grade 1 subluxation of l6 on s1.Minimal spurring of l5 anteriorly.An ap view of the thoracic spine to verify 12 paired ribs may be of benefit.On (b)(6) 2010, the patient presented to the office reporting that he has burning on the sides of thighs, aching/burning in ankles and knees, achy pain across the back of his feet, difficulty in standing for greater than 2 hours.He underwent ct scan and degenerative disc disease was founded.On (b)(6) 2010: the patient was presented with lumbago so he underwent ambulates with compensated trendelenburg to the lumbar with weight bearing on the lumbar.On (b)(6) 2010: patient was presented with discomfort on r side of lb this arm.Patient tolerated treatment well and without adverse effects.On (b)(6) 2010: the patient was presented for follow.On (b)(6) 2010: patient presented for office visit with derm consult.The patient underwent following assessments: lumbar radiculopathy, lumbar degenerative disc disease, lumbar spondylosis, multi-level lumbar fusion.On (b)(6) 2011: patient presented for follow up.On (b)(6) 2011: the patient was presented with septal deformity with chronic maxillary.On (b)(6) 2012: patient presented for follow up.On (b)(6) 2012: the patient presented with low back pain.On (b)(6) 2012: patient called clinic to state the back injury last friday continues to hurt.On (b)(6) 2012: patient underwent 4 views chest x rays including dual energy.On (b)(6) 2012: the patient presented with pre operative diagnosis as history of colon polyps and hemorrhoidal complaints.For office visit.He underwent endoscopy.On (b)(6) 2012: the patient presented with right ankle pain and follow up for his previous problems.On (b)(6) 2012: the patient was presented for follow up.So he underwent review of systems.Impressions of head and neck were the head is normocephalic, the anterior and the posterior cervical triangle cervical, triangle has no masses, lesions, or lymphadenopathy.On (b)(6) 2013: the patient presented for office visit.On (b)(6) 2013: the patient underwent endoscopy.
 
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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 Key5060402
MDR Text Key25158097
Report Number1030489-2015-02247
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 Followup,Followup
Report Date 04/01/2016
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 Date05/01/2011
Device Catalogue Number7510200
Device Lot NumberM110806AAK
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
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/28/2016
06/28/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/11/2010
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) Required Intervention;
Patient Weight114
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