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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthritis (1723); Calcium Deposits/Calcification (1758); Contusion (1787); Cyst(s) (1800); Edema (1820); Muscle Spasm(s) (1966); Neuropathy (1983); Loss of Range of Motion (2032); Swelling (2091); Tingling (2171); Stenosis (2263); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
(b)(6).(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on (b)(6) 2008, patient underwent 1.Anterior lateral lumbar fusion l3-l4 with rhbmp2.2.Anterior lateral instrumentation l3-l4 using lateral plate.3.12 x 50 mm peek cage.4.Bone marrow aspiration right iliac crest with harvesting and transplanting for stem cells with formigraft cancellous bone substitute.5.Intraoperative fluoroscopy, for 1.Lumbar radiculopathy, 2.Lumbar discogenic pain.Per-op notes: bone marrow was harvested from right iliac crest and transplanted for stem cells with fonmigraft cancellous bone substitute.This together with rhbmp-2 sponges were packed into an x-les peek 12 x 50 mm cage.The cage was impacted into place under fluoroscopic guidance.No complications were reported.Intraoperative fluoroscopy was utilized for placement of all hardware with final images obtained, interpreted and saved for the final record.On (b)(6) 2008, patient presented for follow-up two weeks post-op surgery.Patient reported being sore after surgery.X-rays showed the implants in good position.The fusion looked stable.On (b)(6) 2008, patient presented for follow-up.Patient reported numbness in the right lower extremity is moving up and was less severe than it was before, also it was fluttering with occasional spasms, she fell twice since her last visit and been using a cane and a walker with a seat.On (b)(6) 2008, patient presented for follow-up six weeks post-op.Patient reported buttock and back pain.Leg pain was resolved after surgery.X-rays showed the implants in good position.The fusion looked stable.On (b)(6) 2008, patient underwent x-ray of lumbosacral spine which showed right sided plate and screw fixation at approximately the l3-l4 level with posterior fixations at l4-l5 and s1 and intervertebral disc spacers at l4-ls and ls-s1.There were hypertrophic spurs seen in the lumbar spine most pronounced at l3 inferiorly.Cholecystectomy type clips may be present in the right upper quadrant.When compared to (b)(6) 2008, no gross derangement is detected but there were some differences in patient positioning.On (b)(6) 2008, patient presented for follow-up.Patient reported pain since an altercation.Patient had to visit an emergency room.X-rays showed the implants in unchanged position.The fusion looked unchanged.Patient underwent mri of lumbar spine and was diagnosed with lumbar radiculopathy.On (b)(6) 2008, patient underwent mri of lumbar spine with and without gadolinium.Impression: 1.There are three levels that exhibit the stigmata of fusion surgery.Mild flauening of the ventral thecal sac occurs at l3-l4.2.At no level is there evidence of conspicuous granulation scar tissue.Findings demonstrated between l4 and s1 are relatively stable when compared to the 2007 exam.On (b)(6) 2008, patient presented for follow-up.Patient reported midback and right lower extremity pain.X-rays of the lumbar spine showed the implants in good position.The fusion looked stable.Mrj of her lumbar spine on (b)(6) 2008 showed implants were in good position.No evidence of canal stenosis.On (b)(6) 2008, patient reported lower back pain and dysfunction, decreased rom, difficulty getting up-and-down, and difficulty walking.On (b)(6) 2008, patient reported constant pain.Patient was not able to sleep due to pain.On (b)(6) 2008, patient reported constant pain.On (b)(6) 2008, patient reported constant lower back pain.On (b)(6) 2008, patient presented for follow-up.Patient reported pain which had not improved even after physical therapy with swimming pool and with tens unit.Patient's activities still remain limited.Patient reported problem in urinating.On (b)(6) 2008, patient presented for follow-up.Patient reported pain in lb and leg.On (b)(6) 2008, patient reported lb and left buttock pain.On (b)(6) 2009, patient reported ongoing back pain, lot of left knee pain and pain in right buttock.Patient had swelling and some bruising on left knee.Impression: 1.Recent l1-l4 fusion.2.Post laminectomy syndrome with right lumbosacral radiculopathy, status post anterior and posterior fusion.3.L5-s1 disk herniation.4.Chronic pain.X-rays of her lumbar spine indicated implants in good position.No loss of fixation or malalignment was noted.We also did x-ray her left knee; there was no osseous obvious abnormality.On (b)(6) 2009, patient was diagnosed with knee pain and early arthritis of knee.On (b)(6) 2009, patient presented for follow-up.Patient reported ongoing pain after lateral l3-4 fusion.Patient underwent mri and was diagnosed with lumbar radiculopathy.On (b)(6) 2009, patient underwent mri of left knee.Impression: 1.There is no strong evidence for internal derangement.2.There is grade ii-iii chondromalacia patella, ventral soft tissue edema, and a component of bursal effusion.Mri of lumbar spine with and without gadolinium.Impression: 1.There is a satisfactory appearance to the multiple levels of fusion.2.Since the 09/26/2008 study, there has been no significant interval change.In retrospect, there is still some signal alteration of the bone marrow at the l3-4 level.This may reflect the most recent surgery.On (b)(6) 2009, patient reported back pain.Leg pain was better after surgery.Mri of lumbar spine indicated stable implants and there were no changes since surgery.On (b)(6) 2009, patient presented for follow-up for left knee contusion from accident.Mri showed no evidence of meniscal tear.Some chondromalacia was seen.On (b)(6) 2009, patient presented for follow-up.Patient reported back pain.Pain in leg had improved after surgery.Patient had hip bursitis about the left hip.Patient had facet joint pain at l3-l4.Radiographs of the lumbosacral spine indicate fusion at l4-l5 and l5-s1 in stable position.Impression: 1.Lumbar radiculopathy.2.Lumbar discogenic pain.3.Lumbar facet joint pain.4.Left hip bursitis.On (b)(6) 2009, patient underwent ir fluoro guidance needle loc spine.On (b)(6) 2009, patient presented for follow-up for left knee contusion from accident.Ultrasound indicated 1cm x 1cm baker's cyst.On (b)(6) 2009, patient presented for follow-up.Patient reported lot of pain.Doctor advised l3-4 decompression and fusion posteriorly.X-rays showed the previous fusion holding up well.Impression: lumbar radiculopathy with disco genic pain and hip bursitis.On (b)(6) 2009, patient presented for follow-up.Patient reported lot of pain.Doctor advised l3-4 decompression and fusion posteriorly.X-rays showed the previous fusion holding up well.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2009, patient presented for follow-up.Patient reported lot of pain.Doctor advised l3-4 decompression and fusion posteriorly.X-rays showed the previous fusion holding up well.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2009, patient presented for follow-up.Patient reported lot of pain.Doctor advised l3-4 decompression and fusion posteriorly.X-rays showed the previous fusion holding up well.Implants were stable.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2009, patient presented for follow-up.Patient reported lot of pain and was anxious regarding getting surgery done.X-rays showed the previous fusion holding up well.Implants were stable.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2009, patient presented for follow-up.Patient reported numbness, tingling, and increasing pain in back (mostly on left side) whenever she does any activity.Pain radiates down to lower extremities more on left than right.Pain increases with long walks or prolonged periods of sitting.Patient was diagnosed with lumbar disc herniation with radiculopathy.On (b)(6) 2010, patient underwent mri of lumbar spine with and without gadolinium.Impression: 1.There is no significant stenosis seen.2.However, mild compromise of the foramina at l3-4 does occur but is unchanged from the last exam.On (b)(6) 2010, patient presented for follow-up.X-rays showed the previous fusion holding up well.Implants were stable.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2009, patient underwent ir fluoro guidance needle loc spine.Impression: fluoroscopic guided lumbar epidural steroid injection was performed.On (b)(6) 2007, (b)(6) 2009, (b)(6) 2010, patient underwent ir fluoro guidance needle loc spine.Impression: fluoroscopic guided left l3-4 facet injection was performed.On (b)(6) 2010, patient presented for follow-up.Patient reported lot of pain and discomfort.Patient was on hold for surgery due to kidney problems.X-rays showed the previous fusion holding up well.Implants were stable.Impression: lumbar radiculopathy with disco genic pain.On (b)(6) 2011, patient underwent ct abdomen and pelvis without and with contrast.Impression: small 1.1 cm rounded low-density lesion in the lower pole of the left kidney, likely represents a cyst with a slightly elevated hounsfield unit measurement.I would simply advise a progress study in 4-6 months.No other significant abnormalities are noted.On (b)(6) 2011, patient underwent ct abdomen and pelvis without and with contrast.Impression: 1.1.1 cystic left lower pole cystic renal mass unchanged from the prior exam.2.Fatty liver.3.Calcifications at the porta hepatis of uncertain etiology, unchanged from the prior exam and of doubtful clinical significance.On (b)(6) 2012, patient underwent ct of lumbar spine wo contrast.Impression: 1.Facet arthrophy at l2-3, l3-4, l4-5, 2.Surgical fusion with instrumentation at l3-4, l4-5, l5-s1, 3.Moderate narrowing of neural foramina at l3-4, 4.Moderate narrowing of left neural foramen at l4-5, 5.Osteoarthritis of the sacroiliac joint.On (b)(6) 2012, patient presented for a follow-up to get clearance for a hysterectomy.Patient reported chronic back pain with tingling and numbness in right sided lower extremities.Patient had a bladder stimulator placed in (b)(6), 2012 due to bladder dysfunction.X-rays od lumbar spine indicated well-healed fusion, hardware was in good position.There was also evidence of stimulator seen on images.Impression: lumbar radiculopathy with discogenic pain.On (b)(6) 2012, patient presented for follow-up.Patient reported back pain radiating down right leg.Patient was diagnosed with restless leg syndrome.Lumbar spine x-rays showed solid fusion at l3- s1.There was no evidence of any loosening of implants.The fusion was all healed up at all levels.
 
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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 Key5052398
MDR Text Key25010907
Report Number1030489-2015-02184
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 Received09/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
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) Other;
Patient Weight91
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