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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 Insufficient Information (3190)
Patient Problems Arachnoiditis, Spinal (2390); Neck Pain (2433)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
It was reported that on: (b)(6) 2008, patient presented with low back pain.She was admitted with following preoperative diagnosis: degenerative disk disease l5-sl.The patient complained of "having constant sharp burning, stabbing, calling pain in the center of her low back region with occasional pain into her left buttock region and down the back of her left thigh to her left knee with occasional numbness and tingling in her left leg when standing and walking, and mild weakness in her left leg when standing and walking.Patient underwent xrays and physical examinations on the same day.The following procedure was performed: anterior lumbar diskectomy and interbody fusion l5-s i level using peek (polyether-ether-ketone) intervertebral spacer packed with bmp (bone morphogenic protein) with placement of anterior plate and screws l5 to s 1.Per op notes , she underwent laparotomy with left preperitoneal or retroperitoneal exposure of the anterior lumbar spine (l5-sl intervertebral disk space.) during the procedure , the dr.Then made a skin incision in her lower abdomen below her umbilicus.He then did the exposure and did a right retroperitoneal approach at the l5-s 1 disk space.Once he had it exposed then the x-ray was taken and identified the l5-s1 disk.He then entered the disk with a knife and curetted out the disk material.He then sequentially distracted the disk space and maximum distraction was at 12 mm.While the distraction was done, the disk was curetted out.Once all of the disk material was removed, a trial spacer was inserted.X-ray was ( taken and based on this x-ray with the trial spacer in, the decision was made to use the small footprint, 12 mm x 30 mm x 12 degrees lordotic peek (polyether-ether-ketone) spacer packed with bmp (bone morphogenic protein) and then inserted into the l5-s1 disk space.X-ray confirmed good final position of the peek spacer.Then a 21 mm plate was attached to the vertebral bodies of l5-s 1 in good position.Once everything was tightened down, and the cover plate was inserted, then closed the wound.Impression: "patient had low back pain associated with degenerative disk disease at the ls-s 1 level, superimposed upon previous surgery from an anterior approach at the l3-l4 level and l4-l5 level.He thought that she would be able to tolerate a left preperitoneal or retroperitoneal approach." no complication noticed.On (b)(6) 2008, patient underwent xray examination of lumbar spine.Impression: new level of anterior fusion at the ls-s1 level.On (b)(6) 2008, patient was discharged.On (b)(6) 2008, patient presented with pain.Her x rays confirmed the healing of l3-4 <(>&<)> l5-s1.On (b)(6) 2008 , patient presented with lot of pain in her tailbone, back pain , numbness down her leg , cannot walk.On (b)(6) 2008, patient presented for follow-up.Injection in her tailbone has helped her.On (b)(6) 2008, patient presented for injection.On (b)(6) 2009, patient complained of pain down her lower sacral area.X ray confirmed the healed anterior fusion at l3-4 , 4-5 and 5-1.On (b)(6) 2009, patient was informed of her mri scan.Impression : the mri does show some fibrosis and clumping of the nerve roots, so think she doctor is dealing with fibrosis and pain from scar tissue.On (b)(6) 2009, the patient presented with back pain.She underwent following surgical procedure: left-sided l5 transforaminal epidural steroid injection with fluoroscopy.A 25- gauge spinal needle was placed under fluoroscopic guidance at the left l5-s 1 foramen.On (b)(6) 2009, the patient presented for placement of spinal cord simulator lead for trial screening.On (b)(6) 2009, the patient visited for removal of spinal cord stimulator with trial lead.The patient was stable and likely to go with permanent implant.Her suture were cut and leads were removed with tips intact.On (b)(6) 2009, the patient presented for diagnosis of arachnoiditis.The patient implanted with spinal cord stimulator lead and generator.A tunneling device was used to tunnel from the lumbar incision over to the subcutaneous pocket.The tail of the lead was then placed through the tunneling device.The tunneling device was removed leaving the lead tunnel from the lumbar incision over to the subcutaneous pocket.Generator was then secured to the lead with allen screw.Impedance check showed all electrodes functioning.Both wounds were copiously irrigated with antibiotic solution and closed with interrupted 2-0 vicryl.No post op complications.Patient was discharged next day.On (b)(6) 2009, patient presented for x ray examination.Impression : healed anterior fusion at l4-5, l5-s1 with possible pseudarthrosis l3-4.On (b)(6) 2009, patient visited with increasing back pain.Impression ( x ray ): good anterior fusion now l3-4, 4-5 and 5-1 with l5 being transitional.On (b)(6) 2009: ct images of pelvis obtained.Impression: sclerosis of iliac wing near right sacroiliac joint probably related to arthritis.A site of bone harvesting is noted along the right ischium.On (b)(6) 2009, patient presented for follow-up.Si joint looks normal.On (b)(6) 2009, patient presented with pain she has pain is in the mid to lower lumbar spine.On (b)(6) 2009, the patient presented with following prehospitalization diagnosis: 1.Lumbar radiculopathy.2.Multiple sclerosis.She underwent lumbar epidural steroid injection with fluoroscopy.On (b)(6) 2009, the patient presented with following prehospitalization diagnosis: 1.Lumbar radiculopathy.2.Multiple sclerosis.The patient admitted for planned dupens epidural catheter implant.Post op, parenteral opioids were provided for her pain.Her trial was deemed successful and catheter was removed.On (b)(6) 2009, the patient presented with preoperative diagnosis for arachnoiditis.She was admitted for planned implant of intrathecal catheter and programmable pump.Post op , patient complained of a headache which persisted for another day as well.On (b)(6) 2009 , the patient underwent ct.Assessment: thickening of the ethmoids.Headache improved but complaint for constipation.On (b)(6) 2009, she was given a repeat blood patch and neurology was consulted.On (b)(6) 2009, her pain had improved and her bowels were working.Patient was discharged.On (b)(6) 2010 , patient presented for explant of the rod put in post tibial fracture.On (b)(6) 2010, patient was injected in her knee to reduce her pain.She underwent mri which showed some arthritis associated with a bone infarct.On (b)(6) 2011, patient underwent x ray.She complained that post injection of her knee, it hurts more.On (b)(6) 2011, patient presented for follow up evaluation.On (b)(6) 2011, patient presented for patient presented for lumbar epidural steroid injection.On (b)(6) 2011, patient presented for lumbar epidural steroid injection with fluoroscopy.On (b)(6) 2011, patient presented for lumbar epidural steroid injection with dorsal root ganglion radiofrequency ablation with fluoroscopy.On (b)(6) 2011 - patient presented for follow-up meeting to see how her leg is healing.On (b)(6) 2011, patient presented for evaluation on lumbar epidural steroid injection on (b)(6) 2011 patient was injected with marcaine and prednisone in her knee.On (b)(6) 2011, (b)(6) 2012 patient presented for follow-up evaluation on (b)(6) 2012, (b)(6) 2013, (b)(6) 2014- patient was injected with synvisc dose.Per medical records, programmable pump was refilled on: (b)(6) 2012, (b)(6) 2011.On (b)(6) 2011, (b)(6) 2012, patient presented with post laminectomy syndrome -lumbar.Underwent lumbar esi.On (b)(6) 2012 , patient complained of persistent low back pain at sacrum despite esi (epidural steroid injection) (b)(6) 2012 , patient presented with lumbar pain in hx back surgery.Impression: 1.Postsurgical changes,as above, similar to previous study.2.Broad based annular bulge at l3-4 with foraminal encroachment, similar to slightly increased from previous study.3.Small central disc protrusion at l4-5 with foraminal encroachment.Please note the right foraminal encroachment lateral scar is less prominent than on prior study.4.Incidental finding of cyst in the inferior pole of the left kidney.On (b)(6) 2012 patient presented with increase in pain in l3 dermatome.She underwent right l3-l4 transforaminal epidural steroid injection.On (b)(6) 2012, patient presented for implanted programmable pump refill.Patient condition has improved.On (b)(6) 2012, patient underwent mri procedure of lumbar spine with <(>&<)> without contrast.Impression: 1.Postoperative changes with stabilization of the lower lumbar vertebral segments, similar to previous study.2.Findings of annular bulge and lateral foraminal encroachment similar to previous studies.Findings to suggest a recurrent disc is not established.On (b)(6) 2012, patient presented with low back pain.On (b)(6) 2012, (b)(6) 2013, patient presented for implanted programmable pump refill and reprogram.On (b)(6) 2013, pain is well controlled.Patient visited for follow-up and pump refill.On (b)(6) 2013, patient presented for follow-up.Pain has improved.On (b)(6) 2013, patient presented with cervical spondyl w myopathy also underwent mri of spine.On (b)(6) 2013 , patient presented for mri c spine w/o contrast.Impression: 1.Degenerated discs seen at all levels of the cervical spine.There is straightening of normal cervical lordosis.2.At c3-4 there is a broad based diffuse disc that effaces the cord and narrows the left neural foramina.Overall, there is neural canal narrowing at this level.3.At g4-5, neural foraminal narrowing is present.Diffuse disc bulge is seen with more focal disc protrusion at the origin of the left neural foramina.There is mild effacement of the cord 4.Marrow signal is normal.Cord is of normal size and signal.On (b)(6) 2013, patient visited the facility and requested change in prescription of drugs.On (b)(6) 2013, patient presented with brachial neuritis.Following procedure was performed: cervical epidural steroid injection with fluoroscopy.On (b)(6) 2013, patient presented with cervical spondyl myelopathy, brachial neuritis , post laminectomy syndrome lumbar.Patient made visit to facility on: (b)(6) 2013, patient made another visit and diagnosed with post laminectomy syndrome - lumbar on (b)(6) 2013, patient made another visit and diagnosed with cervical spondyl w myelopathy, post laminect synd lumbar.Her pain has improved.Fluoroscopy procedure was performed.On (b)(6) 2013, patient visited for prescription.Her pain has improved.Fluoroscopy procedure was performed.On (b)(6) 2013, patient visited with neck pain, aching ,throbbing, cramping.Patient visited for the follow-up evaluation.On (b)(6) 2013, patient visited the facility.On (b)(6) 2013, patient presented with post-laminectomy syndrome-lumbar.Pain has improved.The patient underwent lumbar epidural steroid injection with fluoroscopy.On (b)(6) 2013, patient presented for follow-up and complained of low back pain.On (b)(6) 2012, (b)(6) 2013, patient presented with pain which has increased without po opioid.The pump was reprogrammed to show the change in reservoir volume and the infusion was programmed for intrathecal dilaudid 12mg on (b)(6) 2013, patient presented with cervical spondyl w myelopathy, brachial neuritis , post laminect synd lumbar.Following procedure was performed : reprogram implanted programmable pump.The patient was identified.The pump was interrogated then reprogrammed to infuse at was intrathecal morphine on (b)(6) 2013 - patient presented for another procedure as pain has increased without po opioid and increase basal rate and ptm, if thus doesn't help i'd recommend increasing bupiv.Per notes the pump was reprogrammed to show the change in reservoir volume and the infusion was programmed on (b)(6) 2013, patient diagnosed for lumbar post laminectomy syndrome.Her pain over the lumbar facets with stress maneuvers.On (b)(6) 2014, patient presented with lumbar post laminectomy syndrom.Her pain has increased.She underwent fluoroscopy procedure -lumbar epidural steroid injection on (b)(6) 2014, patient presented for lumbar post laminectomy syndrom.On (b)(6) 2014, patient presented with cervical spondyl w myelopathy, brachial neuritis , post laminectomy synd lumbar.Following procedure was performed: programmable pump refill.On (b)(6) 2014 - patient presented with cervical spondyle with myelopathy, brachial neuritis , post laminectomy syndrome lumbar.
 
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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 Key5027926
MDR Text Key23985344
Report Number1030489-2015-02074
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 07/27/2015
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 Date08/01/2010
Device Catalogue Number7510400
Device Lot NumberM110704AAH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/29/2008
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 Weight86
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