MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK VERTE-STACK SPINAL SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 2961226

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Neuropathy (1983); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Either 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) 2006: the patient presented with chief complaints of back pain with l5-s1 disc degeneration.The patient underwent the following surgeries: laminectomy l5-s1 with interbody and posterolateral decompression l5-s1 using pedicle screws and interbody fusion cage with infused bmp and cancellous bone chips.Per operative notes: ".I packed some bone and bmp anteriorly in the space and went on to place the cage obliquely in the space and countersunk it appropriately and i got a very snug fit and good ap and lateral images.I placed appropriate sized rods and with final tightening got a stable fixation.I packed the intertransverse bed with a mixture of bmp, local bone and cancellous allograft chips after curetting the transverse processes and the ala of the sacrum on each side.Patient underwent x-ray of lumbar spine.Findings: bilateral pedicle screws are seen at l5-s1.No spondylolisthesis is seen.A prosthetic disk has been placed.Impression: post surgical change (b)(6) 2006 patient presented for an office visit due to status postop l5-s1 fusion.On (b)(6) 2006 patient presented for an office visit due to low back pain and left leg weakness.Impression: s/p lumbar surgery which was presenting with slow progression and some post-surgical pain and weakness.Impairment of mobility and ambulation.On (b)(6) 2007, patient presented for follow-up three month post-op lumbar fusion.Patient reported low back pain.X-rays showed good position of pedicle screw and interbody cage.On (b)(6) 2007, patient presented for follow-up six months post-op lumbar fusion.X-rays showed good position of pedicle screw and interbody cage.There was no evidence of interbody fusion on the lateral view.On (b)(6) 2007 patient presented for an office visit due to low back pain and left leg pain.On (b)(6) 2007 patient presented for an office visit due to postop lumbar fusion.On (b)(6) 2007 patient presented due to low back pain localized to the sagittal spine and left leg weakness.Impression: status post lumbar fusion at l5-s1, poor surgical fusion due to tobacco and nicotine habituation, the surgery fusion was healing very slowly.On (b)(6) 2007 the patient was presented for office visit with low back and left leg pain.On (b)(6) 2007 patient presented for an office visit due to low back pain, lumbosacral spine pain and left leg weakness.Assessment: postop l5-s1 instrumented fusion, poor surgical fusion due to tobacco and nicotine habituation, the surgery fusion was healing very slowly.On (b)(6) 2007 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome status post herniated nucleus pulposus at l5 and s1 root compromise, lumbar transforaminal interbody fusion at l5-s1, gastroesophageal reflux disease secondary to medical organic disorder.On (b)(6) 2007 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome status post herniated nucleus pulposus at l5 and s1 root compromise, lumbar transforaminal interbody fusion at l5-s1, gastroesophageal reflux disease secondary to medical organic disorder.On (b)(6) 2008 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome status post herniated nucleus pulposus at l5 and s1 with re-compromise status post lumbar transforaminal interbody fusion, gastroesophageal reflux.On (b)(6) 2009 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, failed back surgery syndrome.On (b)(6) 2009 patient presented for an office visit.On (b)(6) 2009, (b)(6) 2010 patient presented for an office visit due to low back pain and leg pain.Assessment: chronic low back pain syndrome, chronic lumbar radiculopathy, failed back surgery syndrome/post laminectomy syndrome.On (b)(6) 2009, patient presented with complaint of low back pain and right leg pain.On (b)(6) 2010 patient underwent percutaneous dual lead octad spinal cord stimulator to treat the pre-op diagnosis: failed back surgery, chronic lumbar radiculopathy, chronic low back pain syndrome.On (b)(6) 2010 patient underwent percutaneous dual lead spinal cord stimulator implantation with ipg pocket formation and implantation to treat the pre-op diagnosis: chronic pain syndrome, chronic lumbar radiculopathy.On (b)(6) 2010 patient presented for an office visit due to low back pain.Assessment: chronic low back pain syndrome, chronic lumbar radiculopathy, status post spinal cord stimulator implantation, dual percutaneous leads.On (b)(6) 2010 patient presented for an office visit due to low back pain, leg pain, suture removal.Assessment: chronic lumbar radiculopathy, failed back surgery syndrome, status post spinal cord stimulator implantation.On (b)(6) 2010 patient presented for an office visit to low back pain and leg pain.On (b)(6) 2010 presented for an office visit due to low back pain and leg pain.Assessment: chronic pain syndrome, status post spinal cord stimulator implantation with recent lead migration.On (b)(6) 2010 patient underwent spinal cord stimulator revision, ipg pocket formation and replacement to treat the following pre-op diagnosis: spinal cord simulator migration, spinal cord stimulator ipg malalignment and rotation, m, chronic lumbar radiculopathy and failed back surgery syndrome.On (b)(6) 2010 presented for an office visit due to low back pain and leg pain.Assessment: chronic pain syndrome.On (b)(6) 2010 presented for an office visit due to low back pain and leg pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, status post cord stimulator implantation and revision with successful capture.On (b)(6) 2010 presented for an office visit due to low back pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, status post cord stimulator implantation and revision with successful capture.On (b)(6) 2011 patient presented due to low back pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, permanent spinal cord stimulation implantation.On (b)(6) 2011 patient presented due to low back pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, spinal cord stimulator permanent implantation, successfully capturing all regions of pain, increasing his quality of life.On (b)(6) 2011 patient presented due to low back pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, spinal cord stimulation implantation.On (b)(6) 2011 patient presented due to low back pain.Assessment: chronic pain syndrome, chronic lumbar radiculopathy, spinal cord stimulation implantation, status post failed back surgery syndrome.On (b)(6) 2012 patient underwent ct of lumbar spine without contrast.Impression: extensive bony hypertrophy around an eccentrically placed left-sided l5-s1 disc prosthesis virtually obliterating the left exit foramen.Indistinct cortex along the inferior aspect of l5 on the left which may simply be related to placement of the disc prosthesis but infection cannot be entirely excluded and a contrast-enhanced ct or mri may be appropriate if there was any clinical evidence of infection.On (b)(6) 2012 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome, recurrent of lumbar radiculopathy, history of failed back surgery syndrome.On (b)(6) 2012 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome, history of gastritis with utilization of chronic nsaids due to pain syndrome, history of lumbar radiculopathy, failed back surgery syndrome, spinal cord stimulator implantation.On (b)(6) 2012 patient underwent the following surgeries: right l4 transforaminal lumbar epidural steroid injection to treat the following pre-op diagnosis: lumbar radiculopathy, lumbar discogenic disease, lumbar spondylosis.On (b)(6) 2012 patient presented due to chronic radiculopathy with previous l5-s1 fusion with hardware.Neural stimulator in place, right leg pain.Impression: no herniated nucleus pulposus identified.Nerve root sleeves filing l3-l5.S1 nerve root sleeves not identified.On (b)(6) 2012 the patient underwent ct scan of the cervical spine due to chronic radiculopathy, right leg pain.Impression: l5 and s1 fusion with bilateral pedicular screws and interconnecting rods.There is solitary metallic cage placement which has migrated posteriorly into the left lateral recess with surrounding hypertrophic bony growth severely narrowing the left lateral recess and impinging left l5 nerve root.The right neural foramina is patent.A small metallic density is seen surrounding the right l5 nerve root sheath.On (b)(6) 2013 patient presented for an office visit due to low back and right leg pain.Assessment: chronic pain syndrome, history of gastritis with utilization of chronic nsaids due to pain syndrome, history of lumbar radiculopathy/failed back surgery syndrome with spinal cage migration and metal silver/hard in the descending nerve roots.Proceed with selective nerve root block with corticosteroid for pain attenuation and surgical consultation for revision.On (b)(6) 2013: the patient presented for an office visit with failed back syndrome.On (b)(6) 2013: the patient presented for an office visit with low back pain and right leg pain.Assessment : chronic pain syndrome with exacerbation/chronic lumbar radiculopathy/ failed back surgery syndrome with cage migration and metallic artifact penetrating to the nerve sheath.On (b)(6) 2013 patient underwent the following procedure: explanation of dorsal column stimulator with removal of lamitrode, removal of wiring and ipg battery to treat the following pre-op diagnosis: failed back syndrome, status post implantation of dorsal column stimulator with stimulator failure.On (b)(6) 2013: the patient presented for an office visit with chief complaints of low back pain and bilateral leg pain.On (b)(6) 2013 patient underwent mri of lumbar spine with and without contrast.Impression: status posts anterior and posterior fusion at l5/s1.A bone graft cage is eccentrically positioned in the left posterolateral disc space and there is asymmetric effacement of the left anterolateral subarachnoid space with possible compression of the left s1 nerve root.Correlate with any prior imaging would be helpful.No central stenosis is produced.The left l5 foramen is largely obscured by metallic artifact.On (b)(6) 2015 the patient underwent: right l4 transforaminal lumbar epidural steroid injection.Right l5 transforaminal lumbar epidural steroid injection.Preoperative diagnosis: lumbar radiculopathy, lumbar discogenic disease, lumbar spondylosis.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on: (b)(6) 2014: patient presented for an office visit due to lower back pain.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERTE-STACK SPINAL SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• 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 Key: 5912178
• MDR Text Key: 53442348
• Report Number: 1030489-2016-02433
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041556
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2013

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2961226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2013
• Initial Date FDA Received: 08/29/2016
• Supplement Dates Manufacturer Received: Not provided; 10/02/2013
• Supplement Dates FDA Received: 12/20/2016; 09/25/2017
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Weight: 110