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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cyst(s) (1800); Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2009 the patient underwent a lumbar spine dxa scan.On (b)(6) 2009 the patient presented with low back and leg pain.The patient mentioned that they had a facet joint injection since the last visit.On (b)(6) 2009 the patient presented with pain and underwent l3/4 and l4/5 facet joint injections which seemed to give at least some initial relief.On (b)(6) 2009 the patient presented with low back and leg pain worse with standing, walking, and sitting.A note was made by the patient that they may have had pneumonia.On (b)(6) 2009 the patient presented with back pain that radiated into both legs and the preoperative diagnosis of lumbar degenerative disc disease and herniated nucleus pulposus at l5-s1.The patient underwent a surgery which consisted of a lumbar decompression and transforaminal lumbar interbody fusion at l5-s1 with right sided approach; posterior spinal fusion l5-s1; far lateral decompression right sided l5-s1; left-sided l5-s1 laminectomy; cancellous allograft material; local allograft interbody peek cage with medium infuse; and pedicle screw instrumentation l5 and s1.Per the operative report ¿¿at the l5-s1 level at the midline.The midline was crossed and a near total discectomy was done.The bony endplates were removed of cartilaginous material and disk material, and scraped down to a bleeding bony surface for fusion.Next, approximately 25 ml of crushed cancellous allograft mixed with local crushed allograft was fused in the disk space.One sponge of infuse was also placed anterior in the disk space.The bone graft was packed in place using impact techniques¿.(a) 13mm boomrang cage was chosen.The cage was filled with 1 sponge of infuse as well as local autograft and crushed cancellous autograft material.The cage was subsequently impacted in place¿.¿ fluoroscopic images were utilized to verify position/alignment.Neurophysiologic monitoring was utilized for assessment.No patient complications were reported.On (b)(6) 2009 the patient was discharged from hospital.On (b)(6) 2009, approx.2.5 weeks post op, the patient presented with pain and some numbness in both thighs.The patient was to start physical therapy medications: oxycontin, valium, and norco.On (b)(6) 2009 the patient presented with pain in back, legs, and buttocks worse with sleeping and walking.The patient was wearing a brace and utilizing a cane for ambulation.Per the encounter notes, during preadmission the patient was found to have nodules on the lungs and pancreas and would have a follow-up with a pulmonologist.A drug screen was conducted which was positive for oxycodone and benzodiazepines.On (b)(6) 2009, approx.6 weeks post, the patient presented with significant pain in back and the lateral sides of both legs.Per the encounters notes, x-rays showed early consolidation of fusion.On (b)(6) 2009 the patient presented with low back and surgical pain.On (b)(6) 2010 the patient presented with low back pain.In the encounter notes it mentioned the patient was aggressively undergoing physical therapy.The patient was to restart norco and soma for nociceptive pain control and antispasmodic effect.On (b)(6) 2010 the patient presented with low back, middle and right thigh pain, and leg pain.The patient reported that minimal, daily activities cause pain.A drug screen was conducted which was positive for opioid based drugs and benzodiazepines.It was reported that in a follow up visit the patient would be evaluated for possible sacroiliac joint dysfunction.The patient was to continue use of their tens unit.It was recommended that the patient receive a l5-s1 transforaminal injection.On (b)(6) 2010 the patient presented with low back, right sided hip pain, bilateral buttocks and leg pain (l5 distribution) worse with any activity.In the encounter notes it mentioned narcotic discrepancies and that the patient admitted to having an addiction problem.The patient was considered a possible candidate for suboxone treatment.On (b)(6) 2010 the patient presented with lumbar radiculopathy and underwent a right l4 and s1 transforaminal epidural injection.No patient complications were noted.On (b)(6) 2010 presented with pain which was reported to have increased after an epidural steroid injection but was now calming down.Medications: valium, norco, and oxycontin.On (b)(6) 2010 the patient presented with right hip and low back pain worse with walking and sitting.The patient also reported constipation.Per the encounter notes the patient reported that their surgeon said they might be having a reaction to the bone graft medication given at the time of surgery.Per encounter notes the patient was postright l5 and s1 transforaminal epidural injection and reported increased pain after the procedure.It was noted that the patient decided not to undergone suboxone treatment.It was also reported that the patient had admitted to an addiction problem the previous visit and would not be receiving narcotics from that practice however the patient would be receiving oxycodone from the orthopedic surgeon.A drug screen was conducted which was positive for oxycodone, opioid-based drugs, and benzodiazepines.On (b)(6) 2010 the patient presented with back and radicular pain.It was noted that the patient did have some residual disability but was thought to be capable of performing some limited work.On (b)(6) 2010 the patient reportedly underwent a lumbar ct scan.On (b)(6) 2010 the patient complained of difficulty with activity and that they could not sit, drive, or stand for any prolonged period.Per the encounter notes a lumbar spine ct scan showed early incorporation of the interbody fusion mass at the l5-s1 level but it was not completely fused.There was some evidence of delayed union as opposed to pseudoarthrosis.There was no evidence of root impingement.A bone stimulator was to be ordered and the physician wanted the patient to wear it 24 hrs a day.On (b)(6) 2010 the patient presented with pseudoarthrosis/failed fusion.The patient complained of constant sharp, burning, achy, knife-like, shooting deep heavy back pain radiating into the legs.On (b)(6) 2010 the patient presented back pain and bilateral leg pain, in what appeared to be the l5/s1 distribution.Per the encounter notes a bone scan was performed that showed significant worsening of osteopenia over the last year.Also noted was a vit d deficiency.The patient was being treated for pseudoarthrosis, possible failure of his surgery with use of an external stimulator.The patient underwent a lumbar spine dxa scan which showed significant changes from the last scan ((b)(6) 2009).On (b)(6) 2010 the patient underwent labs which revealed high alk phosphatase.On (b)(6) 2010 the patient presented with osteopenia.Per the encounters notes the patient¿s vit d was on the low side of normal and bone alkaline phosphatase elevated.The patient was continuing to use a bone stimulator.The patient was to see a rheumatologist.On (b)(6) 2010 the patient reportedly underwent a lumbar spine mri which demonstrated that good alignment was present without compression fracture or metastatic disease.The t12-l 1 and l1-2 discs were intact.A mild bulge of the l2-3 disc was seen.Status post well positioned central disc replacements at the l3-4 and l4-5 levels.Status post an anterior and posterior fusion of the l5-s1 level.The anterior fusion was well positioned but demonstrated a delayed union/nonunion.The posterior fusion was well positioned l5 and 51 pedicle screws bilaterally.There was paucity of bone graft around the dorsal rods.The left l5-s1 facet joint had not fused; the right one had been removed top place the l5-s1 anterior fusion.There was no interval change in the appearance of the surgical fusion when compared to the prior ct exam performed on (b)(6) 2010.On (b)(6) 2010 the patient underwent an ecg which was showed borderline t abnormalities.The patient underwent chest x-rays which were unremarkable.On (b)(6) 2010 the patient presented with improved leg pain and stable debilitating back pain.Per the encounter notes a recent ct showed possible delayed union versus nonunion/pseudoarthrosis at l5-s1.A possible anterior lumbar interbody fusion repair/surgery was discussed if back pain was to continue.On (b)(6) 2010, approx.1 year post op.Per the encounter notes, a review of a recent ct scan showed an ¿obvious¿ pseudoarthrosis at l5-s1 at the space of the interbody fusion with no evidence of bony bridging at the l5-s1 level in the anterior disc space.The patient was significantly symptomatic with severe disabling back pain.A revision surgery was discussed.On (b)(6) 2010 the patient presented for chest x-rays.Results: unremarkable.On (b)(6) 2010 the patient presented with back pain with spasms and the diagnosis of degenerative disc disease.Per the encounter notes the patient had not fused at the l5-s1 disc space.The patient underwent surgery which consisted of an anterior lumbar interbody fusion l5-s 1; removal of the interbody cage; exploration of fusion; instrumentation with plate and four screws x 22 mm; machined allograft; local autograph; morselized allograft and a small infuse.Per the operative notes ¿¿distraction was placed across the disk space filled showed clear gross motion across the disk space.This was an exploration of fusion and this was not a healed fusion and was a documented pseudarthrosis¿.Next, a curette was used to remove the scar tissue from the disk space.There was no significantly bridging bone in the distal space at all ¿next, the femoral ring structural spacer was filled in its center with a small infuse pack as well as the morselized allograft and bone marrow aspirate.The femoral ring allograft was subsequently impacted into the disk space¿¿ imaging was utilized to confirm position/alignment of grafts <(>&<)> instrumentation.The following concerning the surgery should be noted: 1) there was extensive scar tissue around the blood vessels around the l5-s 1 level from previous anterior surgery which increased the difficulty level of the surgery significantly; 2) ¿¿ there was definitely more inflammatory reaction around the l5-s 1 disk space than usual and indeed, the left common iliac vein was crossly just above the disk space and was firmly attached to the spine¿¿ ; and 3) during the procedure and while trying to dissect the left common iliac vein further away from the area of the disk space, a small opening was inadvertently made on the vein which was then repaired.The patient reportedly tolerated the procedure well.On (b)(6) 2010 the patient was discharged from hospital.On (b)(6) 2010, approx.2 weeks post op, the patient presented with minimal low back pain and some neck pain.The patient reported some tiredness in legs after walking for a long period of time.Per the encounter notes lumbar x-rays showed hardware in good position.Cervical spine x-rays showed mildly decreased disc space at the c6-7 level.On (b)(6) 2011 the patient presented with almost no leg pain.Per the encounter notes x-rays showed all screws, hardware, and bone graft appearing in excellent position.On (b)(6) 2011 the patient presented with significant progress.The patient was walking better and reported they did not have much pain.The patient did have pain radiating down into the legs after walking for more than 5-10 minutes.Per the encounter notes x-rays showed no lucencies and it appeared to be fusing well.On (b)(6) 2011 the patient presented with significant pain and underwent an evaluation for possible osteopenia.A dexa scan was per formed which demonstrated further loss of bone mass with the t score not consistent with osteopenic-type presentation in the hip which, over the last two years, has dropped by almost 4.6%.Per the encounter notes, the physician wanted the patient to follow up with an endocrinologist and evaluate testosterone levels.On (b)(6) 2011 the patient presented with lumbago.On (b)(6) 2011 the patient presented with improved lumbar and leg symptoms.The patient reported good and bad days but overall was improved.The patient was more active and felt physical therapy was helping significantly.Thea patient also reported neck pain and stiffness.Physical therapy and traction were recommended for this.On (b)(6) 2012 the patient reportedly underwent a lumbar spine ct scan which showed there had been placement of a new prosthetic disc at the l5-s1 level with an anterior plate and screw device.There also was a posterior fusion at the l5-s1 level.The alignment appeared anatomic and canal stenosis was not suspected.A prosthetic disc at the l3-4 and l4-5 levels with artifact resulted in limiting evaluation of the thecal sac but canal stenosis was not suspected.The alignment appeared anatomic.The cat scan of the lumbar spine was otherwise remarkable.A note was made that the patient was not a candidate for narcotics due to narcotic contract violation.On (b)(6) 2012 the patient presented with continued back and leg pain.The patient felt this had stabilized however they were having a major issue with neck pain which radiated into the bilateral shoulders and occasionally down the arms.Per the encounter notes, the physician evaluated a ct scan of the lumbar spine which showed revision fusion at l5-s1 completely solid and fused with hardware in appropriate positions and neural foramina appearing widely patent.On (b)(6) 2013 the patient presented with progressively worsening back pain radiating into the leg bilaterally, stopping at the knees and neck pain with pain bilaterally down arms posteriorly.The patient had numbness and tingling bilaterally in the arms and hands, right > left.Impression: lumbalgia, cervicalgia, myalgia, and cervical and lumbar intervertebral disc displacement without myelopathy.It was noted that the anterior fusion was well positioned but demonstrated a delayed union/non-union and there was a paucity of bone graft around the dorsal rods.A spinal stimulator trail was to be scheduled.Medications: xanax, vit d, vit c ,acidophilus, medrol dose pak, mscontin, norco, soma, naproxen, neurontin.On (b)(6) 2013 per the encounter notes, it stated that the patient had a trial stimulator placement and that the patient felt it gave some relief from their leg and back pain.The patient wanted to keep the spinal cord stimulator.Both leads were removed.It was reported in the encounter that the patient had a synovial cyst at the l3/4 facet but did not want to undergone aspiration treatment.On (b)(6) 2013 the patient presented back and leg pain.The patient was on antibiotics due to an infection and ¿his stim cancelled on (b)(6) 2013 due to infection.¿ on (b)(6) 2013 the patient presented with improved pain and resolving infection.Per the encounter notes the patient was 50% improved since the trial spinal stimulator.Permanent implantation was to be scheduled.
 
Manufacturer Narrative
(b)(6).(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.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
 
Manufacturer Narrative
Review of radiographic images found as follows: (b)(6) 2009 lumbar series ap fluoroscopy shows l5/s1 fusion with prodisc total disc replacements seen at l4 and l3.Lateral views show satisfactory position throughout.Ap and lateral hard films show the prodiscs at l3 and l4 prior to insertion of the fusion at l5.Interbody spacer and pedicle screws are not present in the hard films but are seen under fluoroscopy.On (b)(6) 2010 chest x-rays normal appearing chest x-ray pa and lateral view (b)(6) 2010 lumbar series interoperative fluoroscopy during anterior interbody fusion and augmentation of previous l5 fusion with anterior plate.Interbody peek spacer has been replaced by a different interbody spacer without nytinol markers, possibly a lordotic femoral allograft.
 
Event Description
It was reported that on (b)(6) 2009 the patient was status post lumbar l3-4 and l4-1 disk replacement several years ago.The patient had degenerative disk disease at l3-4, l4-5 and l5-s1 at the time of his initial surgery.The patient presented with back pain, bilateral leg pain and the preoperative diagnosis of lumbar degenerative disc disease and herniated nucleus pulposus at l5-s1.The patient underwent a surgery which consisted of a lumbar decompression and transforaminal lumbar interbody fusion at l5-s1 with right sided approach; posterior spinal fusion l5-s1; far lateral decompression right sided l5-s1; left-sided l5-s1 laminectomy; cancellous allograft material; local allograft material; interbody peek cage stryker 13 mm boomerang shaped cage with medium infuse; and pedicle screw instrumentation using stryker trio pedicle screw instrumentation at l5 and s1.Per the op notes ¿¿at the l5-s1 level at the midline.The midline was crossed and a near total discectomy was done.The bony endplates were removed of cartilaginous material and disk material, and scraped down to a bleeding bony surface for fusion.Next, approximately 25 ml of crushed cancellous allograft mi xed with local crushed allograft was fused in the disk space.One sponge of infuse was also placed anterior in the disk space.The bone graft was packed in place using impact techniques¿ a 13mm boomerang cage was chosen.The cage was filled with 1 sponge of infuse as well as local autograft and crushed cancellous autograft material.The cage was subsequently impacted in place in the disk space and placed in excellent position.Fluoroscopic images were utilized to verify position/alignment.Neurophysiologic monitoring was utilized for assessment.No patient complications were reported.On (b)(6) 2010 the patient presented with back pain and the pre op diagnosis of l5-s1 pseudarthrosis.The patient underwent surgery which consisted of an anterior lumbar interbody fusion l5-s1; removal of the interbody cage; exploration of fusion; instrumentation with synthes plate and four screws x 22 mm; machined allograft; local autograph; morselized allograft and a small infuse.Per the op notes, ¿¿distraction was placed across the disk space filled showed clear gross motion across the disk space.This was an exploration of fusion and this was not a healed fusion and was a documented pseudarthorsis¿.Next, a curette was used to remove the scar tissue from the disk space.There was no significantly bridging bone in the distal space at all¿ next, the femoral ring structural spacer was filled in its center with a small infuse pack as well as the morselized allograft and bone marrow aspirate.The femoral ring allograft was subsequently impacted into the disk space.The remaining morselized allograft as well as local autograft from removal of the osteophytes was impacted into the disk space lateral to the graft on both sides¿ ¿ ap and fluoroscopic imaging was utilized to confirm position/alignment of grafts <(>&<)> instrumentation.No patient complications were reported.
 
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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 Key3999971
MDR Text Key19763506
Report Number1030489-2014-03430
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
Type of Report Initial,Followup,Followup
Report Date 07/15/2014
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 Date06/01/2013
Device Catalogue Number7510200
Device Lot NumberM110915AAH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/28/2015
Initial Date FDA Received08/11/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received12/16/2014
05/27/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/15/2010
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; Required Intervention;
Patient Weight102
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