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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neuropathy (1983); Pain (1994); Swelling (2091); Vomiting (2144); Burning Sensation (2146); Stenosis (2263); Discomfort (2330); Numbness (2415); Nerve Proximity Nos (Not Otherwise Specified) (2647)
Event Type  Injury  
Manufacturer Narrative
(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: (b)(6) 2009, patient underwent mri lumbosacral spine.Study revealed diffuse degenerative changes (b)(6) 2009, the patient presented with low back pain and leg pain.On (b)(6) 2009, patient presented for preop evaluation.On (b)(6) 2009, the patient underwent l5-s1 anterior lumbar interbody fusion for degenerative disc disease and chronic back and leg pain.She underwent procedure: ant.Preperitoneal exposure for l5-s1 bak with isolation, retraction and manipulation of great vessels.Pain pump catheter placement.First assist with instrumentation and anterior lumbar interbody fusion placement.Per op notes, the 10 blade knife was then used to make an incision to the anulus of the l5-s1 disk.A diskectomy was then carried out with pituitary rongeurs as well as straight and angled curettes.Direct fluoroscopic visualization on the lateral was used in guidance for removing of the endplates as well as the disk all the way to the posterior aspect of the disk space itself.Once this was completed, the endplates were then prepared for implantation by scraping the endplates extensively with a curette to assure that all the cartilaginous endplate was removed.Once this was completed, the 6, 8, and 10 mm spacers were then used to distract and open the disk space of l5-s1.Once this was completed, the double barrel distractor was then tamped into position.There was no change in the neurophysiologic monitoring up to this point.Once the double barrel distractor was placed into the appropriate position, the 11 x 23 mm cages were then packed with rhbmp-2/acs and loaded, prior to placement of the grafts, however, the drill bit was set at 18 mm for coring out of the cartilaginous endplate.The pituitary rongeur was then placed through the double barrel distractor to remove any excess disk or endplate that had been removed during the coring procedure.Once this was completed, both of the cages were then placed into the disk space of l5-s1 under direct ap and lateral fluoroscopy to the back third of the disk space.This allowed excellent distraction of the disk space.Once this was completed, the double barrel distractor was removed.The tweezer was then used to assure that both of the cages had solid purchase, which was indeed identified.Two small pieces of bmp were then packed around the grafts themselves.Next, the appropriate sized plate was then placed over the midline and over the junction of the l5 vertebral body in the junction of the sacrum.A tap was then used under direct fluoroscopic guidance to place the screws at a 45-degree angle into the endplates.Once this was completed, 30 mm x 6.5 mm screws were then placed, one into the l5 vertebral body and two into the sacrum.Each of the screws had good purchase.The screws were then tightened down to secure it into position.The plate cover was then applied on (b)(6) 2009, patient called up and complained of right leg pain from ankle up into his buttock and hip area.On (b)(6) 2009, the patient presented for follow-up after alif (anterior lumbar interbody fusion) at l5-s1 using rhbmp-2/acs with a cage implant and stabilization.Impression: ap and lateral x-rays of the lumbar spine reveal placement of cage in the 5-1 interspace with plate and screws in the l5 and s1 vertebral bodies.There is no graft displacement, and screws still have good contact.His disc space appears patent.On (b)(6) 2009, the patient underwent mri spine lumbar w <(>&<)> wo contrast.Impression: at l3-4 , disc narrowing ; l4-5 , there had been a previous right partial foraminotomy.On (b)(6) 2009, patient called and complained of back pain.He was refilled for percocet.Few occasions given epidural steroid injection.On (b)(6) 2009, the patient presented for f/u of alif.Patient complained of swelling and pain.His mri of the lumbar spine was reviewed again.He was given epidural steroid injection.Impression: degenerative disc disease l5-s1, status post anterior lumbar interbody fusion.; continued back and right lower extremity pain, likely neuropathic pain.On (b)(6) 2009, patient called and enquired about his disability status.On (b)(6) 2009, patient was given medicine refill.He presented with back pain.He had two epidural steroid injections since his procedure, (b)(6) 2009 with dr.(b)(6), and (b)(6) 2009, patient was seen in follow-up for low back pain and right leg pain, fever and vomiting.Assessment: low back pain, status post (b)(6) 2009 l5-s 1 fusion.Psycho-socioeconomic duress.Unstable behavior around medications, with risk for chemical dependency.On (b)(6) 2010, patient presented for f/u of back pain.Ct shows l3-4 nerve root on the left contacted and l4-5 nerve roots contacted.The symptoms are from the l1-2 area into his left butt and leg.Impression: multilevel degenerative changes with areas of disk bulge and marginal osteophyte extending along the inferior neural foramen are otherwise unchanged ; l1-s1 level demonstrates anterior pyramid plate fixation.Hardware is intact.On (b)(6), patient presented with bacterial infection of his skin, left pinna, that started at a piercing hole, and had one area of about 4 mm of crusting, left forearm.Assessment: low back pain, radiating into groin and right leg, after (b)(6) 2009 anterior l5-s1 fusion.Question pseudarthrosis (b)(6) 2010, the patient presented for follow up after recent ct scan of lumbar spine.Patient complained of numbness, back pain , lower extremity pain.Patient was diagnosed for intervertebral disc disorders: lumbar intervertebral disc without myelopathy.Assessment: ct scan was reviewed, which again reveals normal anatomic alignment.There was an interbody cage which was a translucent radiographic cage of the l5-s 1 interspace.There were bony columns abutting the l5 and sacral area to suggest early beginning of fusion.Review of his mri scan postoperatively as well as his new ct scan reveals interbody cage placement at 5-1 with appropriate placement of the cage, screws and plate fixation.On (b)(6) 2010, patient presented follow-up for low back pain , complaining of his right middle finger being numb.L5-s1 pseudarthrosis.Substantial lost meds.Episodic median nerve compression, right wrist.He also underwent urine /drug screen and vit d screen.On (b)(6)2010 , the patient presented with preop dx- l3-4 herniated disk- lateral ; and left l3 radiculitis.Per op notes.He underwent left l3 selective nerve root block under fluoroscopic guidance.On (b)(6) 2010, the patient presented with pa chronic pain.Patient also underwent vit d screening.Assessment: pseud-arthrosis, l5-s1.He had no pain improvement.On (b)(6) 2010, patient presented for general f/u and pre-op evaluation.On (b)(6) 2010, the patient underwent radiology smc.Per op notes, he underwent posterior spinal fusion with instrumentation of l5 to s1 with silicate calcium phosphate bone graft supplement.Per op notes , deep self-retaining retractors were placed.Pedicle screws were then placed bilaterally at l5 and sl.Screws were 45 mm in length and 7 mm in diameter.These were polyaxial titanium screws.Patient tolerated the procedure well.Postop dx: l5-s1 nonunion after previous alif.On (b)(6) 2010; the patient presented for f/u of low back pain, nerve pain in his legs was increased by surgery.Assessment: poor tolerance to axial loading.Urine screen performed.No oxycodone in his urine, in spite of being given a large dose on a daily basis.Less than two weeks out on posterior l5-s1 fusion augmentation.The news is tentatively good, in that he tolerates axial loading of his spine sitting in a neutral position.Opiate titration for the pain from his pseudarthrosis.On (b)(6) 2010, the patient presented for ct and follow up of pain.Patient showed (b)(6) 2010, the patient underwent mri at l4-5: bulging annulus which protrudes into the left neural foramen and far laterally likewise appearing to contact the extraforaminal left l4 nerve with similar changes seen on the earlier exam.Enhancement is seen adjacent to the lamina and spinous process at this level which may be secondary to posterior fusion.No central spinal stenosis with mild facet arthropathy.L4-5: right l5 hemilaminectomy changes with mild enhancement surrounding the intraspinal right s1 nerve consistent with postoperative fibrosis.There is similar enhancement involving the paraspinal musculature adjacent to the lamina at l5.Interbody cage and anterior hardware appears unchanged.No evidence for exiting nerve root impingement or central spinal stenosis.Impression: new postoperative changes consistent with posterior fusion at l5-s1 with placement of bilateral transpedicular screws.There are signal changes involving the paraspinal musculature most likely postoperative in origin without evidence for abscess formation or hematoma.No central canal compromise.Chronic low back pain, status post (b)(6) 2010 l5-s1 posterior fusion.He's continued to have pain at the l2-3 area.On (b)(6) 2010, patient presented with mri spine lumbar w and wo contrast.Impression: new postoperative changes consistent with posterior fusion at l5-s1 with placement of bilateral transpedicular screws.On (b)(6) 2010, the patient admitted in pain management department because of chronic back pain.Impression: higher lumbar radicular syndrome associated with foraminal stenosis at l2-3 as well as significant postsurgical pain.On (b)(6) 2010, patient presented for f/u.His leg and back pain is about equally divided.His left leg was worse.Tight left l3-4 foramina.On (b)(6) 2010, patient presented for f/u of his low back pain and also underwent lab test.Low vit d found in (b)(6) 2010.On (b)(6) 2011, the patient presented with burning leg pain.He underwent medicine refill, urine screen , shower chair prescription.On (b)(6) 2011, patient presented for urine /drug screening.On (b)(6) 2011, patient presented with f/u for low back pain , status post l5-s1 fusion procedure.Ct was performed which showed bone growth.Assessment: low vitamin d, persistent ; benzodiazepine from unknown source (b)(6) 2011, the patient presented for lab test - it d 25 hydroxy.Result outcome was normal.
 
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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 Key5093418
MDR Text Key26356280
Report Number1030489-2015-02455
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 08/24/2015
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 Expiration Date04/01/2011
Device Catalogue Number7510400
Device Lot NumberM110802AAC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/22/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/04/2009
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 Weight82
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