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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 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fatigue (1849); Hearing Loss (1882); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Myocardial Infarction (1969); Nausea (1970); Neuropathy (1983); Pain (1994); Pneumonia (2011); Tingling (2171); Depression (2361); Numbness (2415); Sleep Dysfunction (2517); Abdominal Cramps (2543); Ascites (2596); Abdominal Distention (2601)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on: (b)(6) 2004: patient was admitted to the hospital due to back and lateral leg pain with following diagnosis: spinal stenosis.Status post l4 to sacrum, instrumented fusion.Patient underwent following procedures: lumbar decompression l3-4 with instrumented fusion l3-4.Removal of l4 pedicles.Placement of l3 screws bilaterally and replacement of l4 pedicle screws.Posterolateral fusion l3-4 with operation done with brainlab guidance.Allograft bone was used.The screw rod construct at l3-4 was then attached to the previous instrumentation.Physical examination of the patient's neurological systems revealed to be normal except for trace ankle jerks, decreased sensation in the dorsum of his left foot and 4+/5 left ehl.There was tenderness in the lower lumbar spine with palpation.Straight leg raising on the right side with associated back and right leg pain.Impressions: patient developed stenosis at l3-4.Patient was discharged on (b)(6) 2004.(b)(6) 2008: patient presented for an office visit with diagnosis of severe degenerative disk disease l5-s1 with l5-s1 disk protrusion and foraminal stenosis, status post multiple back surgeries with spinal stenosis l2-3, l3-4, status post instrumentation and fusion from l3 through s1 with possible nonfusion, left s1 radiculopathy, status post anterior lumbar interbody fusion l5-s1, discogenic pain l5-s1.Nonfusion l3-4.Procedure: anterior approach to l5-s1 disk.As per op notes: anterior lumbar diskectomy of l5-s1 was done with preparation of inferior endplate of l5 and superior endplate of s1 for interbody allograft fusion.Interbody titanium cage placement l5-s1 utilizing lt titanium cages.Interbody fusion l5-s1 utilizing rh-bmp2/acs.Following implants were also used: crushed cancellous bone.Per op notes, the inferior end plate of l5 and superior end plate of s1 was prepared tor interbody allograft fusion utilizing the curettes.The 8mm and subsequently 10 mm spacer was hammered into the l5-s1 vertebral body utilizing lateral fluoroscopy to confirm the appropriate size of the trajectory.The 14 mm double barrel was then hammered into the l5-s1 disk space and the bone reamers were used to ream out appropriate trajectories for the lt titanium cages and the little titanium cages were screwed into the l5-s1 disk space for interbody titanium cages at l5-s1, which consists of the 14 x 23 mm lt titanium cages.Rh-bmp2/acs was placed inside these titanium cages for interbody fusion at l5-s1.Use of intraoperative fluoroscopy and interpretation of images.Patient also underwent "port image inten" and abdomen (kub).Impression: probable profound ileus less likely partial distal small bowel obstruction.The patient's had a fusion with paraspinal rods at l3-l5.No abnormal foreign bodies.There is a drain in place.The patient was noted to have on postoperative day #1 hypoactive bowel sounds.By postoperative day #2, he was noted to have abdominal bloating and was unable to pass gas, but he did have positive slow bowel.By postoperative day #3, he was complaining of abdominal pain.Patient has some mild blood loss anemia which was asymptomatic.The patient did develop hypotension (b)(6) 2008: the patient presented for an office visit with diagnosis of degeneration r/o bowel obstruction.Impression: patient vomited gastrografin and exam is limited but again differential between profound postop ileus and distal small bowel obstruction.(b)(6) 2008: the patient underwent abd series sup,erect,dec,1vw cx due to distention and abdominal pain.Impression: upright chest shows some discoid atelectasis.The heart is slightly prominent.No free air.We are seeing large amounts of fluid with multiple fluid levels in small bowl, also in colon.There is very severe ileus or diarrhea.When we do the kub, there is no free fluid.It is bothersome to see very little distal colon.There may be some descending colon.It is very small and it is smaller than the small bowel.We may be dealing with a partial small bowel obstruction, i see what appears to be some much dilated colon also despite the fact that what i can see the descending does not appear to be enlarged.We might start with a water-soluble enema to be certain we are not dealing with a colon obstruction.Depending on how big the colon is on the enema, i would help to evaluate whether it is just an ileus or partial small bowel and i am worried about a partial small bowel because all the fluid levels in small bowel loops i am seeing.No free fluid, masses or abnormal calcifications.The patient has had recent surgery.I am worried because of the difference in size of the small bowel and proximal colon with the distal colon.Colonic distention.The small bowel appears decompressed at the present time.(b)(6) 2008: the patient had the following pre-operative diagnosis: sepsis; need for close hemodynamic monitoring.He underwent the following procedures: placement of left subclavian with cordis introducer; placement of swan-ganz catheter.No patient complications were reported.(b)(6) 2008: the patient had the following pre-operative diagnoses: peritonitis.Transverse colon perforation.Sepsis.He underwent the following procedures: second look laparotomies.Segmental colon resection.Creation of end ileostomy.Abdominal closure.No patient complications were reported.Findings: well perfused ileum and transverse colon except for approximately 4 cm on the proximal transverse colon near the previous resection site.Minimal inflammation.(b)(6) 2008: the patient had the following pre-operative diagnosis: unstable hypotension requiring multiple pressors.He underwent the following procedure: placement of a left femoral arterial line.No patient complications were reported.The patient underwent kub (abdomen) due to degeneration post op, colostomy.Impression: no unexpected foreign body of the abdomen after surgery.(b)(6) 2008: the patient underwent chest portable single view due to swan-ganz catheter placement and degeneration resp distress.Impression: bilateral alveolar type pulmonary infiltrates.These appear slightly improved from film from earlier in the day.(b)(6) 2008: the patient underwent chest portable single view and "abdomen(kub)" due to respiratory distress and degeneration distention.Impression: mild bibasilar atelectasis and/or pneumonitis with probable small pleural effusions.There is also increased density in the peripheral regions which may be due to edema.Mild ileus.Volume toss and/or infiltrate at the bases.No significant change from the previous day.There is fluid in both bases, slightly greater on the left than the right vascularity appears normal.Heart size is normal.We have a problem with motion which is blurring the markings around the hila.On the right side there probably is a small patch of pneumonia just lateral to the right hilum.I think it was probably present on the previous, and it is even smaller now.Patients mri revealed severe degenerative disk disease with disk protrusion and foraminal stenosis at l5-s1 secondary to previous disk surgery.(b)(6) 2008: the patient underwent chest portable single view due to respiratory difficulty.Impression: bilateral peripheral atelectasis as well as left basilar infiltrate similar to that study one day earlier.(b)(6) 2008: the patient underwent ct of abdominal with<(>&<)>w/o pelvis due to abdominal pain and distention.History of lumbar fusion.Impression: there is moderate diffuse ascites.There are postop changes.No mass lesion is seen.The patient has had previous lumbar fusion.There are small bilateral pleural effusions with basilar atelectatic changes.(b)(6) 2008: the patient underwent chest portable single view due to degeneration cough.Impression: two nodular opacities in the right lung.Bilateral basilar infiltrates and/or atelectasis.(b)(6) 2008: the patient was discharged from the facility.(b)(6) 2008: the patient presented for an office visit with complaint of pain, numbness and tingling in his left anterior thigh.The patient was scheduled to undergo revision of the ileostomy.(b)(6) 2008: the patient presented for an office visit with complaint of residual pain.Patient had complicated postoperative course requiring colostomy, an ogilvie syndrome type situation.X-rays reveal partial detachment of the rod from the pedicle screw at l2 on the right, although the screw on the left appears to be in excellent position and he has no definitive symptomatology that can be traced to this (b)(6) 2008: the patient underwent frontal and lateral views of the lumbar spine due to status post lumbar spinal surgery.Impression: multiple surgical dips in the upper abdomen.What appears to be an ostomy in the right lower quadrant as well as a gastrostomy tube in the upper abdomen.Extensive surgical changes of the lumbar spine are noted as described above.There is a suggestion of lucency around the l3 pedicular screw, to a lesser degree l4 pedicular screws, of which underlying and/or infection cannot be excluded.Additionally there is also a suggestion of a disruption of the head of the right l2 pedicle screw and interconnecting rod.Correlation with the known intraoperative findings is recommended.(b)(6) 2008: the patient underwent frontal and lateral views of the lumbar spine due to degenerative disc disease.Status post lumbar spinal surgery.Indications: overall relatively stable appearance of the lumbar spine post spinal fixation.No definite evidence for new abnormality.(b)(6) 2008: the patient presented for an office visit with chief complaint non-healing incision, partial bowel resection, myocardial infarction.(b)(6) 2008: the patient presented for an office visit with chief complaint of fatigue, back pain.(b)(6) 2008: the patient presented for an office visit with chief complaint for pre-op physical.E/n/t exam revealed partially obscured by clear drainage; edematous mucosa.(b)(6) 2008, (b)(6) 2009, (b)(6) 2012: the patient presented for an office visit with chief complaint of diarrhea and cough.Associated symptoms include abdominal cramping and nausea, constipation.Ros: constitutional: positive for fatigue.Musculoskeletal: positive for myalgias.(b)(6) 2008: the patient presented for an office visit with chief complaint of knee pain.(b)(6) 2009: the patient presented for an office visit with chief complaint of sinus symptoms.His primary symptoms include dry cough, frontal facial pressure, nasal congestion, itching, post-nasal drip and clear rhinorrhea, ventral hernia present in patient.(b)(6) 2009, (b)(6) 2011: the patient presented for an office visit with chief complaint of abdominal pain.He characterizes it as cramping and sharp.Associated symptoms include nausea and distended abdomen.(b)(6) 2008, (b)(6) 2010: the patient presented for an office visit with chief complaint of sore throat.Associated symptoms include chills, fever, malaise, purulent rhinorrhea and "swollen glands (b)(6) 2011: the patient presented for an office visit with chief complaint with upper back pain and a tingling sensation.Associated symptoms include stiffness.(b)(6) 2011: the patient presented for an office visit with chief complaint of hearing loss.Associated symptoms include cough, diminished hearing, nasal congestion and popping sounds in the ear.Pertinent history includes allergies.(b)(6) 2008, (b)(6) 2011: the patient presented for an office visit with coronary artery disease and chronic back pain.Ros: psychiatric: positive for insomnia and decreased motivation.(b)(6) 2012: the patient presented for an office visit with chief complaint of toenail fungus and low back pain.Toenail onychomycosis noted.Has a history of low back pain, associated symptoms include stiffness and paravertebral muscle spasm.Ros: constitutional: positive for fatigue and unintentional weight gain.Psychiatric: positive for feeling of stress and insomnia, depression.(b)(6) 2013: the patient presented for an office visit with chief complaint of allergies and shoulder pain.He complains of right shoulder pain.The location of the pain is lateral.Related symptoms include shoulder stiffness.Ros: neurological: positive for paresthesia (right hand, fingers 2-5.Better with movements).Right shoulder examination revealed palpation.(b)(6) 2013: the patient presented for an office visit with chief complaint of low back pain and nausea.The back pain discomfort is most prominent in the mid and lower lumbar spine.This radiates to the left anterior and posterior thigh.(b)(6) 2012, (b)(6) 2013, (b)(6) 2014: the patient presented for an office visit with chief complaint of low back pain, chronic insomnia, chronic low back pain, coronary artery disease, of native coronary artery, essential hypertension, lumbar spinal stenosis, obstructive sleep apnea seborrheic keratosis.The pain radiates to the left posterior thigh.He characterizes it as severe.This is a chronic, but intermittent problem with an acute exacerbation.Back exam revealed: neurovascular: sensory deficit noted in the left (l4) distribution; deep tendon reflexes, limited active rom.Assessment: lumbosacral radiculopathy.
 
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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 Key5179327
MDR Text Key29298325
Report Number1030489-2015-02802
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
Report Date 09/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2010
Device Catalogue Number7510600
Device Lot NumberM110610AAJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/28/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2007
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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