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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 Muscle Spasm(s) (1966); Neuropathy (1983); Loss of Range of Motion (2032); Tingling (2171); Stenosis (2263); Joint Disorder (2373); Numbness (2415); Sweating (2444)
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 patient presented with preoperative diagnosis of: facet syndrome, back pain.Procedure performed: bilateral facet blocks 3-4, 4-5, 5-1.On (b)(6) 2006, patient presented with problem of pain.On (b)(6) 2006 patient presented with pa and lateral chest exam.Impression: no abnormality identified.On (b)(6) 2006 patient admitted with following diagnosis: degenerative disk disease and discogenic pain.Procedure performed: posterior lumbar fusion [.3-4.4-5.Posterior segmental instrumentation l3-4, 4-application of spacers to l3-4, 4-5 with posterolateral fusion l3-4, 4-5.Auto graft and rh-bmp2/acs.Posterolateral fusion l3-4, l4-5.Laminectomies and foraminotomies at l3-l4.Per-op notes: a 14x 26-mm spacer was inserted at the 4-5 disc space and a 22mm placed at the 3-4 disks: space.Ap and literal fluoroscopy showed good position of the screws and the spacers in the 3-4 and 4-5 disk spaces.Irrigation once again was performed, and rh-bmp2/acs was mixed with hydroxyapatite and placed in the posterolateral gutters at 4-5 and 5-1; 7-mm rods were then cut and put in to place, tightened and torqued to the appropriate foot-pounds of pressure with compression across the disk space.A single 305 crosslink was put in place, tightened and torqued to the appropriate foot-pounds of pressure.The breakoff screws were broken off.Other implants: break-off screws, medium connector, pre-cut rod, crosslink, screw, small connector.On (b)(6) 2006 patient underwent bilateral lower extremity doppler venous ultrasound.Conclusion: negative for dvt in either leg.Po st-surgical and post traumatic change as described.While there may be some mild fecal stasis in the colon, no convincing evidence for fecal impaction.On (b)(6) 2006 patient underwent x-rays.X-rays show the rod and screw device bone graft in the posterolateral gutters.The pliff spacers are in good position.On (b)(6) 2006 patient presented with complaint of some numbness and tingling in her legs.On (b)(6) 2006 patient presented with complaint of her leg pain.X-ray addendum: x-rays show the rod and screw device are in good position.The interbody spacers are in good position.There is bone graft, scant, in the posterolateral gutters.Impression: status post fusion, with residual leg pain, chronic pain.Impression: status post fusion, two months.On (b)(6) 2006 patient presented for follow-up visit because of her persistent "jumping of her legs".On (b)(6) 2006 patient presented with complaint of limited range of motion.X-rays: her x-rays today look good.They show the rod and screw device are in good position.The anterior puff spacers are in good position.Impression: restless leg syndrome; status post fusion.On (b)(6) 2006, patient underwent cervical mri test.There is a little bit of left sided stenosis at c-3/4, however, none of this would contribute to the "jerking" of her legs.In the thoracic spine, she does have a minimal disc bulge at t-12/l-1, but again, this would have no significant impact on her lower extremities.On (b)(6) 2006 patient underwent emg.Impression: psychosomatic pain with trochanteric bursitis.Impression: c3-4, there is uneovertebral spacing causing minimal left sided paracentral stenosis and minimal left side neural foraminal stenosis.C4-s.There is minimal disc bulge causing minimal central stenosis.Cs-6, minimal disc bulge causing minimal central stenosis.C6-7, there is diffuse disc bulge causing mild central stenosis and there is a right paracentral disc protrusion encroaching upon the right neutral causing right sided neural foraminal stenosis.Mrl lumbar spine with and without contrast.Impressions: at d12-l1, l1-2, and l2-3, there is diffuse disc bulge causing mild central stenosis.Pedicle screws seen in l3, l4 and l5 with interconnecting rods and laminectomy defects.At l5-s1, there is minimal disc bulge without significant central stenosis.Incidental note is made of some enhancing scar on the right lateral aspect of the l4-5 disc space going around the thecal sac laterally at l4-5 without significant effacement of the thecal sac.On (b)(6) 2007 patient presented with problem of her leg.X-rays: her plain x-rays show the rod and screw device are in good position with solid fusion.The anterior spacer was in good position.Again, right now, we will follow her along.Impression: l.Status post fusion.Status post fall with minimal back pain."jerking" of the legs.On (b)(6) 2007 patient presented with complaint of pressure in the lower part of her back over the sacroiliac.Impression; trochanteric bursitis.Sacroiliac joint dysfunction.Facet syndrome.Low back pain.Status post fusion with residual symptoms.X-rays: plain x-rays show the rod and screw device is in good position.The plif spacer is in the midline.Everything appears to be well aligned and bone gran appears to be incorporating.On (b)(6) 2007 patient underwent emg test.Ncv: prolonged terminal latency of the right personal nerve.Normal ncv of all nerves tested in the lower extremities bilaterally.Emg: positive sharp waves were seeing the right l3 paraspinal muscles.On (b)(6) 2007 patient presented with complaint of pain.Emg and nerve conduction study did show a change on the right-hand side, but she is still having problems with the leg pain.Impression: low back pain.Lumbar radiculopathy.On (b)(6) 2007 patient underwent ct lumbar spine myelogram.Impression: previous fusion of l3-4 and us.Herniation of disk material of l2-3.More on the left than on tile right.Some bulging noted at l1-2 exam otherwise not remarkable.Postsurgical changes with fusion at l3-4 and l4-s as mentioned, herniation of d1sc material at l3-4.This is more on the left than on the right bulging of disc material at l1-2 without significant spinal stenosis.On (b)(6) 2007 patient underwent ct myclogram.Ct myelogram does show a herniation at the l2-l3 level, which is above the level of her fusion and has no relationship to her on-the-job injury.Impression: herniation at l2-l3.Low back pain.Lumbar radiculopathy.On (b)(6) 2007 patient presented with preoperative diagnosis of facet syndrome, back pain, spondylosis.Sl joint dysfunction.Trochanteric bursitis.Procedures performed: bilateral facet blocks 5-1, bilateral sacroiliac joint injections, right trochanteric injection.On (b)(6) 2007 patient presented with complaint of pain.X-rays: looking at her x-rays, the spacers are in good position and there does appear to be bone graft in the posterolateral gutters.Impression: low back pain.Lumbar radiculopathy.On (b)(6) 2007 patient presented with complaint of severe pain.Impression: low back pain.Lumbar radiculopathy.On (b)(6) 2007 patient presented with preoperative diagnosis of lumbar degenerative disc disease.Procedure performed: lumbar discography at l1-2, l2-3 and l5-s1 under fluoroscopy with injection of contrast.Impression: positive provocative discography at l2-3 and l5-s1 with a negative control disc at l 1-2.Abnormal discography at l2-3 and l5-s1 with normal disc at l1-2.On (b)(6) 2007 patient presented with problem of limited range of motion.Impression: status post fusion with retained hardware.Degenerative disc disease with positive discogram at l2-l3 and l5-s1.On (b)(6) 2007 patient underwent following procedure: lumbar spine ap lat.Posterior stabilization procedure l3, 4 and 5.Chest 2 views impression: no acute pulmonary or pleural disease.On (b)(6) 2007 patient presented with preoperative diagnosis of retained hardware.Procedure performed: removal of posterior segmental instrumentation and exploration of fusion.No complications.On (b)(6) 2007 patient presented for follow-up visit for her hardware removal.Impression: low back pain.Lumbar radiculopathy.On (b)(6) 2008 patient presented to discuss lab results, complaints of numbness in the 4th and 5th digits of the left hand.On (b)(6) 2008 patient underwent cnc neurology test.Conclusion: cts- median sensory.Cubital tunnel syndrome.Ulnar nerve block at elbow.Normal ncs leg.On (b)(6) 2008 patient presented with complaints of bad head congestion and non-productive cough, sinuses, numbness in fingers, low back pain.On (b)(6) 2008 patient presented for follow-up visit.Patient complaint of pain.Impression: degenerative disc disease.Low back pain.On (b)(6) 2008 patient presented with following preoperative diagnosis: lumbar degenerative disc disease, facet arthropathy and post lumbar laminectomy syndrome.Procedure performed: lumbar facet block at l2-3, l3-4, l4-5 and l5-s1 bilaterally.Complications: none.On (b)(6) 2008 patient presented with complaints of hyperlipidemia, sweating, and thirst.On (b)(6) 2008 patient underwent bilateral mammogram.Conclusion: stable mammogram with no evidence of malignancy.On (b)(6) 2008 patient examined for high cholesterol, high bp.On (b)(6) 2008 patient underwent eeg, eog, emg, ecg tests.Impressions: good control of vents was observed.Some alpha intrusion continued to be present.On (b)(6) 2008 patient presented with complaints of sweating, leg cramps.Impression: hyperhidrosis possibly a dysautonomia, as patient does have a number of spinal cord issues related to her back.On (b)(6) 2008 patient complaint of increasing low back pain.On (b)(6) 2009 patient presented with complaint of pain.Patient felt extreme pressure in her back "pelvis girdle' and down the leg.Anterior part of the knee is numb.On (b)(6) 2009 patient visited for refill medicines and discuss lab results.On (b)(6) 2009 patient presented for follow-up visit.She still continues lo complain of pain in the lower back down her left leg.Patient underwent x-ray.Impression: degenerative disc disease-lumbar spine, with disc herniation at l2-l3.Low back pain.Lumbar radiculopathy.On (b)(6) 2010 patient presented with chief complaint of left breast soreness in upper outer quad.Review of musculoskeletal system: arthralgias.On (b)(6) 2010 patient underwent radiology test.Impression: birad2- no mammographic evidence of malignancy.On (b)(6) 2010 patient presented with chief complaint of severe left upper quadrant pain, low bp.Review of musculoskeletal system: back symptoms.Review of neurological system: sensory disturbance.On (b)(6) 2010 patient presented for follow-up visit.Review of musculoskeletal system: normal.Review of neurological system: abnormal wide based, walks with a walker.On (b)(6) 2011 patient presented with chief complaint of unable to take kadian.Need to discuss power chair / evaluation.Review of musculoskeletal system: muscle spasm of the shoulder.Tenderness on palpation of the pelvic girdle.Review of neurological system: sensory exam abnormalities were noted.On (b)(6) 2011 patient underwent bilateral digital mammography.Impressions: stable breast with no significant lesion noted.On (b)(6) 2011 patient underwent ultrasound test.Conclusion: negative renal ultrasound.No doppler evidence of renal artery stenosis.On (b)(6) 2011 patient underwent mri.Conclusion: normal left and right ventricular function.No pericardial effusion.Impaired left ventricular relaxation.Slightly elevated velocity across the aortic valve.On (b)(6) 2012 patient presented with chief complaint of management of htn, hyperlipidemia, and low bp.Review of musculoskeletal system: normal.Review of psychological system: normal.Review of neurological system: normal.On (b)(6) 2012 patient presented with chief complaint of bp elevation.Review of musculoskeletal system: normal.Review of psychological system: normal.Review of neurological system: normal.On (b)(6) 2012 patient underwent bilateral digital mammography.Impression: stable breasts with no significant lesion noted.On (b)(6) 2012, (b)(6) 2013 patient presented with chief complaint of panic attack.She falls due to weakness in the knees.She fell in the bathroom and is sore in her pelvis.Review of neurological system: a decrease in concentrating ability was observed.Executive functions were decreased.Review of psychiatric system: normal.Assessments: chronic constipation, hypothyroidism, hyperglycemia, cervical disc degeneration, peripheral neuropathy, muscle spasm, sciatic radiculopathy.Standing pa view of pelvis: the anterior rim of the pelvis appears tilted somewhat more cephalic in position than usual, with relationship to the iliac wings.Standing ap and lateral views of left hip: left hip has a normal appearance with no fracture, dislocation or significant arthritic process.There is no osteochondroma extending off the left ilium laterally.On (b)(6) 2013 patient presented with chief complaint of pain.On (b)(6) 2013 patient presented with chief complaint of pain in right ring and pinky fingers.Review of musculoskeletal system: no axillary lump.Review of psychological system: no depression.On (b)(6) 2013 patient presented with chief complaint of discuss labs and 6 month rechecks apt.Review of musculoskeletal system: finger systems, hand systems, back, and arthralgias.Review of psychological system: sleep disturbance.
 
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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 Key5059805
MDR Text Key25110993
Report Number1030489-2015-02237
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 08/17/2015
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 Number7510800
Device Lot NumberM115010AAI
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;
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