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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

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MEDTRONIC SOFAMOR DANEK CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem Pain (1994)
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2005 the patient presented with a herniated disk at l5 nerve root.On (b)(6) 2005 the patient presented with pain and underwent a lumbar mri which demonstrated mild degenerative disc disease at l4-l5 and l5-s1 with disc dehydration and disc space narrowing; a small central annular tear with tiny central disc protrusion at l4-l5 without overt mass effect on the thecal sac; mild-to-moderate facet degenerative change at l4-l5 and l5-s1; and mild narrowing of the nerve root foramen bordering on mild stenosis bilaterally at l4-l5.On (b)(6) 2005, reportedly, the patient presented in er with pain and received and injection for pain.On (b)(6) 2005 the patient underwent an emg and nerve conductive study which suggested early and mild denervation of the right l5 nerve root suggesting l5 radiculopathy.There did not appear to be any peripheral neuropathy or lumbo sacral plexopathy.On (b)(6) 2005 the patient presented with back pain with radiation into both lower extremities, right > left.In the encounter notes it states a mri demonstrated desiccation at l4-5 and l5-s1 with decreased disk space.¿overall i think (the patient) ¿has a chemical radiculitis and l4-5 and l5-s1 lumbar disk syndrome.On (b)(6) 2005 the patient received and epidural injection.On (b)(6) 2005 the patient received and epidural injection.On (b)(6) 2005 the patient presented with back and leg pain.The received and epidural injection.Per the encounter notes the patient had received three epidural injections without receiving any relief.The patient would have flare-up pain a day or two after an injection.On (b)(6) 2005 the patient reported that physical therapy had not helped with pain not did three epidural injections.The patient complained of low back and right leg pain.On (b)(6) 2006 the patient presented with chronic central low back pain and radiating leg pain, right > left.The patient underwent a lumbar discography which suggested concordant pain predominately at l5-s1 followed by l4-5.L3-4 did have a slight annular tear, but that was not painful.On (b)(6) 2006 the recent discogram was reviewed.The injections at l4-5 and l5-s1 produced severe concordant pain.The injection at l3-4 produced no pain.This corresponded with the mri findings.From the surgical stand point it was suggested that the patient would require a l4-5 and l5-s1 anterior lumbar interbody fusion with application of prosthetic bone devices and anterior plating and posterolateral fusion with autologous iliac crest bony grafting at l4-5 and 51.On (b)(6) 2006 the patient presented with pain and the pre-operative diagnosis of l4-5, l5-s1 lumbar disc syndrome and underwent surgery which consisted of a l4-5 <(>&<)> l5-s1 anterior lumbar interbody fusion with application of prosthetic bone device and anterior plating and posteolateral fusion at l4, l5, and s1 with autologous iliac crest bone grafting.Per the operative notes ¿¿we had previously reconstituted bone morphogenic protein sponges harvested vertebral bones placed into the center of two sponges, and placed into the center of a 19mm grafttech allograft forming the prosthetic bone device.This was tamped into position and countersunk.Its fit was excellent.¿¿ post-plating fluoroscopy showed satisfactory placement of plate, screws, and graft.No patient complications were noted.On (b)(6) 2006 the patient was discharged from hospital.On (b)(6) 2006 the doctor recommended that the patient have home health care initially post op.On (b)(6) 2006 the patient presented with some low back pain and some mild groin pain.On (b)(6) 2006, approx.1 month post-op, the patient presented some low back pain and mild groin pain.On (b)(6) 2006 the patient presented with low back pain that radiated into the left groin.On (b)(6) 2006 the patient presented with a well healed posterior incision but edema and some pain around the anterior operative site.On (b)(6) 2006 the patient presented with some abdominal pain.X-ray showed consolidating fusion at l5-s1 and l4-5.On (b)(6) 2006 the patient presented with continued abdominal pain around the incisional site.On (b)(6) 2006 the patient presented improving symptoms.On (b)(6) 2006 the patient presented with low back pain and the functional assessment of ¿light category¿.On (b)(6) 2007 the patient reported back pain and that without medication the pain was out of control and they could not function.The patient also reported only being able to get 3-4 hours of sleep at a time due to the pain.The pain went into the patient right leg to foot and left leg to knee.The patient had not worked since 2005 due to back injury subsequent pain.On (b)(6) 2007 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient reported improved sleep.(b)(6) 2007 the patient presented with significant back pain with radiation into legs on (b)(6) 2007 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient reported having fallen two week prior and injuring their right elbow.The fall aggravated the patients back which resolved back to where it was before fall.The patient was still having pain and spasm.The patient was now using a cane to avoid falling.On (b)(6) 2006, reportedly, x-rays were taken which showed fusions getting more solid.On (b)(6) 2006 the patient presented for a f/u.In the notes it stated the patient had completed therapy.It also stated that an x-ray showed solid fusion.On (b)(6) 2006 the patient underwent a functional capacity evaluation.It was recommended that the patient have a permanent 20lb lifting restriction.From (b)(6) 2004 to (b)(6) 2006 the patient underwent physical therapy.On (b)(6) 2007 and (b)(6) 2008 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient used a cane for ambulation as needed.The patient had previously been declared mmi.The patient reported having two episodes of chest pain in the past two weeks, both times going to the er, where they were told ¿his heart was ok¿ and that it was only chest wall pain.The patient reported that cold weather and activity made the pain worse.On (b)(6) 2008 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient used a cane for ambulation as needed.The patient underwent labs which were normal.On (b)(6) 2008 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient reported having had to go to the er the night previously for a severe pain with headache.On (b)(6) 2008, (b)(6) 2009, (b)(6) 2010 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient used a cane for ambulation as needed.On (b)(6) 2009 and (b)(6) 2009 the patient underwent labs which showed the patient¿s alkaline was high, white blood cell count high, and absolute neutrophils levels high.On (b)(6) 2010 the patient presented with back pain with spasm.Per the encounter notes it mentioned that the patient had undergone functional evaluation and it was recommend that the patent have a permanent 20lb lilting restriction.On (b)(6) 2010 the patient complained of back and radicular pain; left lower quadrant incisional hernia pain; and muscle spasms.Per the encounter notes the patient still had kidney stones and diverticulitis.On (b)(6) 2010 the patient presented with increasing low back and abdominal pain with pain radiating into both lower extremities.On (b)(6) 2010, the patient underwent lumbar myelogram with post-myelogram ct scanning that demonstrated a solid fusion at l4-5 and l5-s1 with no motion with flexion-extension and no compromise of the thecal sac or foramen.At l3-4 there was a slight anterior disk bulge which was accentuated with standing and flexion, and decreased with extension.The post-myelogram ct scan demonstrated a minimal retrolisthesis of l3 on l4 with mild to moderate spinal stenosis.On (b)(6) 2011 the patient presented for chronic pain management.The patient reported lumbosacral discogenic pain with off and on radicular pain.The patient uses a cane for ambulation as needed.On (b)(6) 2011 the patient underwent a lumbar discogram which showed normal architecture with no pain production at l2-3.L3-4 did show abnormal architecture with concordant pain correlating to disc protrusion at l3-4 with stenosis.It was noted that the patient required a l3-4 direct lateral interbody fusion with posterior non segmental fixation.This could not occur until after recovery form hernia repair.The patient also underwent a lumbar spine ct post discogram which demonstrated fusion at l4-5 and l5-s1 and multiple fissures which allowed contrast into the periannular space.Slight disc bulging was also present.There was mild to moderate stenosis.Both foramina were partially compromised with perhaps minor impingement of the l3 nerve root.There were some minor spondylosis changes at l4-5.On (b)(6) 2011 the patient underwent surgery for an abdominal hernia repair.On (b)(6) 2011 the patient presented with for a post op f/u.On (b)(6) 2011 the patient underwent labs which showed the patient¿s glucose was high, alkaline was high, white blood cell count high, and absolute neutrophils levels high.On (b)(6) 2011 the patient presented with a history of chest pain and underwent a chest x-ray which showed no acute cardiopulmonary abnormalities.On (b)(6) 2011 the patient presented with severe low back pain and was recovering from a herniorrhaphy.On (b)(6) 2011 the patient underwent a hip bone mineral densitometry test which was indicative of osteopenia.On (b)(6) 2011 the patient presented with the preoperative diagnosis of l3-4 degenerative lumbar disc disease with lumbar stenosis post l3-4 direct lateral interbody fusion.The patient underwent surgeries which consisted of a l3-4 lateral interbody fusion; application of prosthetic bone device l3-4; use of morsellized and then bone graft.The patient then underwent the second surgery which consisted of a l3-4 posterior non-segmental fixation using medtronic 5.5x 25 cortical bone screws l3, l4 bilaterally; decompression lumbar laminectomy l3-4; local autograft harvest; and l3-4 bilateral facet fusion.Fluoroscopy was utilized for placement.Per the operative report ¿we then assembled the prosthetic bone device, this consisted of a medtronic clydesdale 50 x 10 mm prosthetic bone device that was filled with one bone morphogenic protein sponge and nucel morsellized allograft.This was then tamped into positioned under fluoroscopic guidance until the graft was completely across the interspace and centered on the spinous process.We confirmed this with ap and lateral fluoroscopy, after this, the inserter was removed and we reconfirmed position of the graft¿¿ it should be noted that per a operative report a ¿¿probe was used to probe the psoas muscle and we used evoked potential monitoring and testing.We had no response as we dissected through the muscle tissue.We docked into the anterior portion of the l3-4 interspace.Again we tested and had no response on evoked potential monitoring.We then drove a kwire into the center of the disc space.This was confirmed on a.P and lateral fluoroscopy¿.¿ no patient complications were noted.On (b)(6) 2011 the patient presented for post op f/u.Overall the patient was making slow progress, reported quite a bit of pain and paresthesia in right thigh, weakness in the right lower extremity and swelling in the low back.On (b)(6) 2011 the patient presented with low back and leg pain and paresthesia in the right thigh and lower extremity.The patient stated the pain seemed worse than pre-operatively.The patient was ambulating with the assistance of a walker.The patients neurotin was increased and they were prescribed soma.On (b)(6) 2011 the patient presented with back and right leg pain.A lumbar spine ct was taken which demonstrated vertebral bodies were intact and alignment was straight.Scans from the lower thoracic through the l2-3 level are normal.Scans from l3-4 through l5-s1 showed post-fusion findings that appeared solid.There was no visible compromise of the canal or foramina at these levels.There was unroofing of the spinal canal across the l3-4 and l4-s levels.The l5-s1 level was not unroofed.There was no significant compression of the thecal sac.Lumbar x-rays were also taken which showed a solid fusion from l3-4 through ls-sl.There was no visible motion with flexion and extension and no compromise of the canal or foramina.On (b)(6) 2011 the patient presented with increased severe pain down the right lower extremity.The patient reported being on soma and neurontin additional to their other medications.The patient wanted the right sided hardware to be removed.On(b)(6) 2011, the patient presented with pain and parathesis and the preoperative diagnosis for l3-4 degenerative lumbar disc disease status post l3-4 direct lateral fusion with posterior nonsegmental fixation l3-4 with medtronics cortical screw fixation.The patient underwent surgery which consisted of removal of right non-segmental fixation l3-4.Per the operative report: ¿¿.I then dissected laterally exposing the right sided medtronic cortical screw system.The locking caps were removed at l3 and l4.The rod was removed and the screws sequentially removed¿¿ no patient complications were noted.On (b)(6) 2011 the patient reported improved symptoms since the last surgery.The patient did report some weakness in the leg and low back pain but that right lower extremity pain was greatly improve on (b)(6) 2011 the patient presented quite a bit of back pain however reported that the left leg pain had resolved.On (b)(6) 2012 the patient presented for chronic pain management.Pain management visits took place every three months.The patient complained of lumbosacral discogenic pain with off and on radicular pain.Since the patients redo surgery the pain was reported as worse.The patient was utilizing a cane for safe ambulation.The patient was prescribed: gralise, zanaflex, cymbalta, ambien, ultram, norco, phenergan, and trazadone.Lumbar x-rays were take which showed solid fusions l4-5, ls-s1; recent fusion at l3-4 was healing in the interspace, but there was sign of movement of the pedicle screws on the right side at l3 and l4 consisting of about a 1 cm halo around portions of the screws.On (b)(6) 2012 the patient presented slow progress.The patient had quite a bit of low back pain however right leg pain was resolving.The patient was wearing a lumbar brace and utilizing a cane for ambulation.Lumbar x-rays showed l3-4 shows a posterior lumbar interbody fusion with posterior instrumentation.The fusion materials appeared to be in good position and alignment and the fusion looked like it is healing.There was no sign of loosening of the unilateral hardware on the left side at l3-4 posteriorly.On (b)(6) 2012, approx.8 months post op, the patient presented with back pain and pain in both extremities.The patient underwent lumbar x-rays which demonstrated fusion findings at l3 4 through l5-s1.The appearance had not changed compared to the previous study from (b)(6) 2012.There was no sign of loss of integrity to the fusion.On (b)(6) 2012, reportedly, the patient underwent a lumbar myelogram ct which showed l4-5 and l5-s1 fusions appearing solid and not foraminal compression.The t3-4 fusion was incomplete.There was a halo around the l3 facet screws.There was mild stenosis.There was a noted wondering if the pain was related to a hip dysfunction.On (b)(6) 2012 the patient presented with a clinical history of copd and underwent chest x-ray which showed hyperaeration of the lungs with some displacement of pulmonary vasculature and other lung changes suggesting elements of copd and perhaps some emphysematous blebs.Prebronchial thickening was present in the hilar areas extending into the lower lungs.There was no evidence of any acute parenchymal process.The patient also underwent an ecg which was normal.On (b)(6) 2012 the patient presented pain and the preoperative diagnosis of pseudarthrosis.The patient underwent surgery which consisted of removal of left l3-4 cortical screws; harvest of left iliac crest, use of morsellized allograft, posterolateral fusion l3-4; posterior non-segmental fixation bilaterally l3-l4 with legacy pedicle screw fixation.Fluoroscopic guidance was utilized throughout.All screws were potential tested.Ssep monitoring was stable.A lumbar spine x-ray showed good alignment.No patient complications were noted.On (b)(6) 2012 the patient was discharge from hospital.On (b)(6) 2012, in a telephone encounter, the patient reported severe pain in left knee with radiation through the left calf region.The patient felt it was different than the paresthesias they had experienced prior to the last surgery.The patient underwent a venous doppler which was negative for the right lower extremity.On (b)(6) 2012 the patient reported pain worse than before the last surgery and severe in the right lower extremity.The patient reported severe muscle spasms in the posterior lumbar para-spinal musculature.On (b)(6) 2012 the patient presented severe pain.The patient was unable to bear weight on the right leg.The pain had escalated since the last surgery.The patient underwent a lumbar myelogram which demonstrated a possible impingement by the right l3 pedicle screw, potentially stimulating the l3 and/or the l4 nerve roots.Also noted was a small spinal canal, but otherwise unremarkable examination.A ct scan showed the ¿right l3 pedicle screw traverses the pedicle and is associated with nonfilling of the right l3 nerve root.¿ the pelvis soft tissues were normal, including the piriformis muscles and sciatic notch, with no sign of piriformis syndrome; the sacroiliac joints were normal.X-rays of the bilateral hips showed the hip joints looked normal.There were no congenital anomalies.A lumbar spine x-ray showed there was no movement of the hardware or sign of nonunion at l3-4.L4-5 and l5-s1 showed a solid alif.On (b)(6) 2012 the doctor made note that the patient had undergone a myelogram.The doctor felt that it was suspect for a right l3 pedicle screw irritating the nerve root.It was recommended that the patient undergo surgery for removal of the internal instrumentation on the right side.On (b)(6) 2012 the patient presented with intractable right leg pain and the pre-operative diagnosis of post l3-4 direct lateral interbody fusion with posterior non-segmental fixation l3-4 with radiculopathy.From ct scans it appeared the l3 pedicle screw breached the medial cortex and may have been irritating the root.The patient underwent surgery which consisted of removal of nonsegmental fixation l3.Per the operative report ¿.We then dissected laterally exposing the pedicle screw system on the right and left at l3-4.This was a legacy pedicle screw system.The locking caps were removed, the rods removed, and the screws sequentially removed¿.¿¿ there were no patient complications reported.On (b)(6) 2012 the patient presented with back and hip pain.The pain was described as burning, throbbing, aching, and stabbing.The patient also reported weakness in legs and arms.On (b)(6) 2012 the patient presented with improved pain in right lower extremity and some back pain most notable during weather changes.The patient underwent lumbar spine x-rays which demonstrated solid fusion at l3-4 through l5-s1.Alignment was straight at all three levels.There was no sign of loss of integrity to the fusion and there was no visible compromise of the spinal canal.On (b)(6) 2012 the patient presented with increasing low back pain due to a knot in the incisional area.The patient reported that this started three weeks prior.The patient also reported increased inflammation in the low back with weather changes.On examination a 2 x 2 inch area in the mid position of the incision was found to be hard to the touch, there were no signs of infection or inflammation noted.It was noted that the patient remained temporarily, totally disabled.A lumbar spine x-ray was taken which showed no changes in comparison to (b)(6) 2012 study.On (b)(6) 2013 the patient presented with some pain and muscle spasms in the back and lower extremities.The patient underwent lumbar spine x-rays which were compared to radiographs from (b)(6) 2012.The patient had fusion from l3-4 through l5-s 1.The lower two levels were supported by individual anterior plates.Alignment across all three levels was straight.There was no visible compromise of the spinal canal.On (b)(6) 2013 the patient presented with chronic severe back pain and underwent a lumbar ct myelogram which demonstrated the appearance of a solid fusion; no extradural deformity of the thecal sac; a substantial csf leak l4 vertebral body; there was the suggestion of inelasticity of both the thecal sac and the scarring in the posterior back at the level of the unroofing of the spinal canal.On (b)(6) 2013 the patient presented with severe low back pain and lower extremity pain, right > left.There was some concern for pseudarthrosis.The patient underwent a lumbar spine x-ray which showed a l3-4 interbody fusion material and a nonunion with gas appearing in the disc space.Solid fusion at l4-5 and l5-s1.L1 and l2 were unremarkable.On (b)(6) 2013 the patient presented with back pain and minimal leg pain.The patient ambulated with the use of a cane.Per the doctors notes a ct myelogram showed some bone formation but not enough to stabilize the interspace.There was no nerve root compression.¿from the surgical stand point we felt that our options would be to proceed with an anterior approach to remove the dlif graft and perform an anterior lumbar interbody fusion with anterior plating but i am hesitant about this approach due to the calcification in his aorta, and the previous scarring from his l4-5 and l5-s1 360.I think this would put us at significant risk for a major vascular injury.The second option would be to re-instrument the l3-4 space posteriorly and reinforce his posterolateral fusion.But, in the past he has been unable to tolerate facet screws or pedicle screw fixation.Our third option would be not to proceed with surgical treatment and just observe him.¿ the patient did not want to pursue surgery at that time.There was some bone forming laterally around the dlif which was hoped to stabilize the interspace further.On (b)(6) 2013 the patient presented with low back and hip pain.The patient denied lower extremity symptoms.Lumbar spine x-rays were taken which showed some halo around l5 interspace but still looked like the posterolateral fusion was solid.L5-s1 showed solid fusion.There was some movement at l3-4 and the vertebral bodies were extremely sclerotic.On (b)(6) 2013, in a doctor¿s letter, it was stated that the patient¿s recent x-ray showed slight motion at l3-4 but they suspected this would solidify.L4-5 and l5-s1 fusions appeared solid.On (b)(6) 2013 the patient reported continued pain with radiating into the lower extremities, right greater than left.Flexion ¿extension films of the lumbar spine showed a solid appearing l3-4 fusion.On (b)(6) 2013 the patient presented low back pain with radiation into the lower extremities, right > left.The patient reported the pain interfered with normal living activities.The patient utilized a cane for ambulation.On (b)(6) 2013, in a doctor¿s letter, it was stated that the patient¿s lumbar and l3-4 fusion appeared solid based on x-rays.On (b)(6) 2014 the patient underwent a functional capacity evaluation.Results reported stated the patent was capable of performing ¿light¿ physical demands.No more than 20lbs lifting.On (b)(6) 2014, based on the results of the functional capacity evaluation, the doctor recommended a 20lb lifting restriction and a 17/20lb push/pull restriction.The patient was released from care at mmi status.On (b)(6) 2014 the patient underwent a lumbar spine mri which demonstrated extensive post-surgical changes in the lumbar spine such as a 3 mm disc bulge with osteophytic ridging extending into the central canal at 3-4.There was mild central canal stenosis due to facet hypertrophy and prominence of bone graft material, especially on the left side; and there was inhomogeneous increased signal in the vertebral body at l3 with some enhancement.
 
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.
 
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Brand Name
CD HORIZON SPINAL SYSTEM
Type of Device
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key3915793
MDR Text Key4488579
Report Number1030489-2014-03038
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 06/09/2014
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2014
Initial Date FDA Received07/07/2014
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) Required Intervention;
Patient Weight77
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