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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 Neuropathy (1983); Pneumonia (2011); Scarring (2061); Fibrosis (3167)
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) 2006: the patient underwent ct lumbar spine post myelogram.Impression: 1.Status post l4-l5 fusion.2.Degenerative l2-l3 change with large extruded fragment extending inferiorly narrowing the canal, compressing the thecal sac on the left.The patient also underwent lumbar myelogram due to back pain.Impression: lower lumbar fusion.L2/3 stenosis eccentric on the left with probable disc herniation and retrolisthesis.(b)(6) 2006: the patient presented for an office visit.Her ct scan was reviewed which showed herniated disc at l2-3 with inferior migration behind the body of l3.Her symptoms were bilateral.(b)(6) 2006: the patient presented with a complaint of intense back pain that had been present for two months.Review of systems revealed arthritis, cough, shortness of breath, acute respiratory infection, and sinus trouble.Physical exam revealed tenderness throughout the midline of her lower back.She was also tender over the trochanters.Her voluntary motion in her back was very limited.She had more pain with extension than with flexion.She was unable to walk on the heel of the right foot.The x-ray examination revealed that she had an interbody fusion at l4-5 that seemed solid.She had internal fixation and pedicle screws and rods.She has no apparent destructive disease or instability or radiographic evidence of major change at the adjacent segments.Diagnosis: recurrent low back pain, chronic radiculopathy at l5 on the right.(b)(6) 2006: the patient presented with following preoperative diagnosis: lumbar radiculopathy.The patient underwent bilateral l2 t ransforaminal epidural steroid injections using fluoroscopic guidance.No patient complications were reported.(b)(6) 2006: the patient presented for an office visit.She fell about a week or 2 ago and had had increasing pain in her lower back radiating around into her left groin.X-ray examination of the lumbar spine and of the pelvis revealed no clear evidence of fracture.She had multifocal degenerative changes and postsurgical changes in her lumbar spine as previously described.The patient underwent bona scan.Impression: no significant change from (b)(6) 2006 study.Persistent moderate abnormal uptake region of l2 vertebral body.Degenerative spondylotic chanqe with no fracture noted on post myelogram lumbar ct from (b)(6) 2006 2.Stable arthritic uptake left knee dorsal mid-foot reqions bilaterally, bilateral shoulders and sternoclavicular joint, and left 1st mcp joint and minimally about both hips.(b)(6) 2006: the patient presented for an office visit.The bone scan showed increased activity around the degenerative change at l2-3 where she had a ruptured disc.(b)(6) 2006: the patient presented with severe pain in the back with radiating distress into the left lower extremity.Physical exam showed that she had complete foot drop noted on her right side.She also had some tenderness in the mid lumbar region.Her reflexes were diffusely hypoactive.She had weakness of her hip flexors on the left side and she has diminished sensation in the l2 and l3 and l4 dermatomes on the left side.She had decreased sensation in the l5 dermatome on the right side.Straight leg raising produced lower back pain.X ray of her spine showed instrumentation at 4-5 level.Fusion did not seem solid.She had some lucency about her screws.She had considerable degenerative changes with disc space collapse of the 2 - 3 level.On her myelogram she had a fairly sizable extradural defect at level of the disc space and this appeared that she had a large disc herniation at that level of signific ant stenosis.(b)(6) 2006: the patient presented with severe and intractable right lower extremity pain.The patient underwent the following procedure: bilateral decompression l2-3 and l3-4 with excision herniated nucleus pulposus l2-3, left.The patient underwent intra-op view of the lumbar spine.Conclusion: surgical instruments and probes overlie the posterior elements and disc space at l2-3.(b)(6) 2006: the patient presented for a follow up office visit.(b)(6) 2006: the patient presented with severe pain in her back.Her x-ray looked fine.(b)(6) 2006: the patient presented with a complaint of pain.She had pain primarily in her back but when she stood she got radiating distress into the lower extremities.Ap and lateral x-rays of her lumbar spine demonstrated the area of her previous decompression at the 2-3 level.She had marked degenerative changes at that level, a little bit of retrolisthesis of 2 on 3.(b)(6) 2006: the patient underwent mr of lumbar spine due to lumbar disc displacement.(b)(6) 2006: the patient presented for a follow up visit due to severe pain in the back radiating into her left lower extremity, left thigh.Her mri was reviewed.She has evidence of a recurrent disc herniation at the 2-3 level.On physical examination she seemed to have some mild weakness of her hip flexors on the left side.The patient underwent pa and lateral chest x-ray which showed degenerative changes in spine.(b)(6) 2006: the patient presented with increasingly severe pain, status post surgery.The patient underwent the following procedures: 1.Removal of instrumentation lumbar spine.2.Redo partial hemilaminectomy l2-3 on the left, excision of recurrent herniated nucleus pulposus, 3.Bilateral lateral fusion l2 to l4.4.Bilateral instrumentation l2 to l5.5.Autogenous iliac crest bone graft from left supplemented by rh-bmp2/acs.Per op note, the bone graft yield was fairly poor so the decision was made to use rh-bmp2/acs, a large 2 kit was selected and the rh-bmp2/acs was reconstituted and applied to a collagen sponge which was cut.A 35 x 6.5 screws were used at l2 and l3 and 35 x 40 screws were placed in the previous screw holes at l4 and l5.The rh-bmp2/acs soaked collagen sponge was rolled over some of her bone graft to create a non-compressive cylinder construct.After decortication was carried out, bone graft was packed bilaterally and the rh-bmp2/acs collagen sponge rolled over the bone graft was packed bilaterally.Rods were applied.No patient complications were reported.The patient underwent three views of lumbosacral spine due to post op pain.Impression: 1.Severe disc space narrowing at l2/3, questionably progressed with associated sclerosis of the end plates, questionably progressed.The 5 mm retrolisthesis of l2 in relationship to l3 probably not significantly changed.2.The patient is status post l4/5 bilateral pedicle screws and fusion unchanged.3.Incidental note made of degenerative spurring of the lower thoracic spine.The also underwent intra-op fluoroscopic imaging.(b)(6) 2006: the patient presented with the chief complaint of fever, increased white count, increased back pain.Physical exam revealed an obvious foot drop on the right which was unchanged.X-rays of her chest demonstrate some mild interstitial disease.The patient underwent the following procedures: 1.Debridement and irrigation of spinal wound.2.Redo partial hemilaminectomy l2 on the left with excision of retained herniated nucleus pulposus.No patient complications were reported.(b)(6) 2006: the patient underwent ct of abdomen and pelvis with contrast due to right lower quadrant pain.Impression: 1.Small effusion at the right base with overlying minimal atelectasis or infiltrate.2.Surgical clips seen in the gall bladder fossa.3.Cortical scarring associated with the right kidney with simple cyst associated with the superior pole of the left kidney.4.No explanation for the patient's abdominal pain seen.30 aug 2006: the patient underwent xray of chest single view for iv line placement.Impression: successful picc placement.Ill-defined right upper lobe process with possible new lung nodules.Finding is concerning for right lung pneumonia.The patient also underwent ct of chest.(b)(6) 2006: the patient was discharged.(b)(6) 2006: the patient presented for a follow up office visit.(b)(6) 2006, (b)(6) 2006: the patient presented for a follow up office visit.Ap, flexion/extension, lateral x-rays of her lumbar spine demonstrated good position of her instrumentation.No obvious lucency about the screws, no motion on flexion/extension views.(b)(6) 2006: the patient underwent mri of lumbar spine w <(>&<)> w/o contrast.Opinion: there is some enhancing scar posteriorly.Extensive spinal fixation, and with ferromagnetic artifact.L3 remains slightly anterior in relation to l2.No unequivocal recurrent disc herniation.(b)(6) 2006: the patient presented for a follow up office visit.She continues to complain of a lot of pain in her back with radiating distress into both lower extremities, worse on the right than the left, she says her symptoms are there primarily when she stands, it doesn't bother her too much with sitting.Ap and lateral x-rays of the lumbar spine demonstrate good position of the instrumentation.There is nothing to suggest obvious gross loosening.Fusion mass isn't really all that well developed, it is hard to say whether she has got any motion there or not.She may be rocking back slightly at 2 on 3.Ap, flexion/extension lateral x-rays of the lumbar spine demonstrate good position of her instrumentation.No evidence of gross loosening.Mri: mrl of her lumbar spine is reviewed.There's a lot of metal artifact noted.No fluid collections and her disc herniation were resolved.11 dec 2006: the patient underwent mri of lumbar spine.Impression: post-op changes.She also underwent post myelogram ct of lumbar spine.Impression: 1.Postoperative change, with fusion extending from l2 to ls and interbody fusion at l4-5.2.Retrolisthesis at l2-3 causing some impingement on the anterior aspect of the thecal sac though it appears the thecal sac is just deviated posteriorly due to the retrolisthesis with a decompressive laminectomy posteriorly at this level.3.There is a slight spondylolisthesis at l4.5.4.Small disc bulge at l5.1.(b)(6) 2006: the patient presented for a follow up office visit.Myelogram and ct scan is reviewed.This demonstrates good position of her instrumentation.I don't see any evidence of significant nerve root compression on this study.(b)(6) 2007, (b)(6) 2007: the patient presented for a follow up office visit.(b)(6) 2007: the patient presented for a follow up office visit.Her emg nerve conduction study was reviewed.This demonstrates evidence of a fairly severe peripheral polyneuropathy.She has focal chronic involvement of the left peroneal nerve and severe chronic but incomplete involvement of the right peroneal nerve.There is no evidence of acute or chronic 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 Key5063240
MDR Text Key25214544
Report Number1030489-2015-02257
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
Date FDA Received09/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date08/11/2008
Device Catalogue Number7510800
Device Lot NumberM115006AAJ
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/11/2015
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) Required Intervention;
Patient Weight80
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