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

Catalog Number 2961222

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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.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

On (b)(6) 2009 : pre and post op diagnosis: spinal stenosis l2-l3 with herniated disk, degenerative disk disease, disco genic pain and instability procedure: posterior lumbar interbody fusion at l2-l3; implantation of peek spacer l2-l3; posterior nonsegmented instrument ation l2-l3; posterolateral fusion l2-l3; lumbar laminectomy with foraminotomies and discectomy l2-l3.It was reported that the patient underwent spine fusion surgery on the lumbar region of her spine from vertebrae l2 to l3 using rhbmp-2 from a posterior and posterolateral approach.The rhbmp-2 collagen sponge was placed outside a cage (i.E., in the lateral gutters).Patient's post-operative period has been marked by progressively worsening low back pain, with radiating pain and numbness in both legs.Radiographic imaging demonstrated subsidence of the interbody cage and bony overgrowth where rhbmp-2 was implanted in patient's lumbar spine.Patient continued to experience chronic lower back pain, with pain radiating to both legs, numbness and tingling in both legs and feet, and muscle cramps and spasms.Patient experienced difficulty in sitting, standing, and walking for any extended duration, and required use of a cane and walker to assist in ambulation.Patient also suffered from bladder issues, anxiety, and depression.Patient was basically home bound and constantly took medication.These serious injuries prevented patient from practicing and enjoying the activities of daily life that she enjoyed pre-operatively, and she otherwise suffered serious and permanent injuries.On (b)(6) 2010: lumbar mri with and without contrast reveals extradural filling defect at l2-l3 level, more on right than on left.Causing some encroachment on right neural foramen and impingement on the right nerve root.Minimal bulging at l3-4 and l4-5 without significant spinal stenosis.Some overgrowth of the facet joints can be seen at each of these levels.On (b)(6) 2010: the patient presented with numbness and pain in both legs, which did not exist prior to the plif.On (b)(6) 2010: complains of bilateral le pain, numbness and tingling from both thighs to both feet including her toes which started a year ago after her lumbar surgery.April 10 le emg showed a mild demyellnating and axonal asymetrical sensory motor polyneuropathy.Patient given neurontin 800 mg tid and naprosyn 500 mg bid.On (b)(6) 2010: patient presents for follow up after mri.Lumbar radiculopathy, narrowing of l2-l3 due to extra bone.On (b)(6) 2010: the patient underwent discogram at l3-l4, l4-l5 and l5-s1.There is clear evidence of bony overgrowth as a result of the plif procedure performed on patient.The patient experiences tremendous pain on a daily basis.On (b)(6) 2010: ct and fluoroscopic guided discogram.Alignment of fused vertebral bodies is normal with respect to remainder of lumbar spine.There is mild posterior disc bulges but no significant spinal canal stenosis.No subluxation or significant spinal canal stenosis.On (b)(6) 2013: the patient underwent myelogram of the lumbar spine.Impression: previous anterior and posterior lumbar fusion l2-l3 with ventral extradural defect but no sleeve defects at that level.The patient also underwent ct of lumbar spine due to back pain.Impression: previous anterior and posterior lumbar fusion l2-l3 with osteophytes slightly narrowing the right foramen but no spinal stenosis or left foraminal encroachment.Posterior bulge of the disc and facet hypertrophy producing spinal stenosis and a mild bilateral foraminal encroachment l3-l4.Posterior bulge of the disc and facet hypertrophy slightly narrowing the foramina without spinal stenosis at l4-l5.On (b)(6) 2013: the patient presented with bony overgrowth.

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.

• 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: 6299458
• MDR Text Key: 66433854
• Report Number: 1030489-2017-00220
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00885074018676
• UDI-Public: 00885074018676
• 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
• Report Date: 01/09/2017

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: 2961222
• Device Lot Number: HO6M5705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: 01/09/2017
• Supplement Dates FDA Received: 09/28/2017
• 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