MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Catalog Number 7510400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neuropathy (1983); Weakness (2145); Dizziness (2194); Stenosis (2263); Arthralgia (2355); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.

Event Description

It was reported that on (b)(6) 2006, the patient presented for examination with complaint of back pain and thigh pain.The patient underwent a surgery with diagnosis of 1) lateral disk herniation, l3-4 with associated left l3 radiculopathy.2) spinal instability/advanced degenerative disk disease, l3-4.Procedure performed: 1) l3-4 spinal decompression, left, with discectomy through posterolateral/ wiltse approach.2) l3-4 posterior lumbar interbody fusion.3) implantation cage, single implant, l3-4.4) l3-4 posterolateral spinal fusion.5) use of local bone graft/ morselized bone graft.6) pedicle screw instrumentation/ nonsegmental instrumentation; l3-4 using xia.7) use of rh-bmp2/acs.8) continous emg monitoring of the bilateral l3-4 nerve root.Per op-notes, after the complete discectomy with removal of the cartilaginous end plate, the cannula was tamped into position and using c-arm control the hole was reamed, tapped, and then a 12 mm in diameter x 26 mm in length cage was implanted.This was then packed with rh-bmp2/acs soaked sponges, and then the cap was placed.Pedicle screws were then placed.Pedicle screws were placed in the left l3 and l4 pedicles using anatomic landmarks and c-arm guidance.After the placement of 2 pedicle screws, a rod was selected, bent into-lordosis, and affixed to previously placed screws.Excellent fixation was obtained on the left side.The exact same procedure was then performed of the right side through a separate incision 4 cm off the midline.The exact same procedure was performed on the right side with the exception that the transverse processes at l4 and l3 were decorticated, and then graft local bone graft and rh-bmp2/acs sponges were packed over the lateral gutters prior to placement of the pedicle screws.After placement of the pedicle screws, using c-arm guidance and anatomic-landmarks, the screws were stimulated and emgs were obtained, and all the screws were above the threshold, indicating placement within the confines of the pedicle.A 2nd rod was placed on the right side and then fixed.Excellent fixation was obtained bilaterally.On (b)(6) 2006, the patient presented for preop visit with complaints of lower back pain.On (b)(6) 2006, the patient was discharged with diagnosis of l3-4 herniated coleus pulposus/ instability with radiculopathy.On (b)(6) 2006, the patient presented for follow-up evaluation with complaints of left lower extremity radicular pain.The x-rays of the lumbar spine showed the fusion at l3-4 was coming up nice.There was no evidence of loosening or failure of the hardware.The ray cages and pedicle screws were in satisfactory position.On (b)(6) 2007, the patient underwent a xray of lumbar spine including flexion and extension views that showed fusion at l3-4 was solid and there was no evidence of loosening or failure of hardware.On (b)(6) 2006, the patient presented for a follow-up status post l3-4 decompression and fusion surgery.The x-rays of lumbar spine showed the fusion at l3-4 was good and there was no evidence of loosening or failure of hardware.On (b)(6) 2006, the patient presented for follow-up with complaints of left quadriceps weakness.The x-rays of the lumbar spine including flexion and extension lateral views, showed a solid interbody fusion at l3-4.On (b)(6) 2007, the patient presented for follow-up with complaints of neck pain with radiation into the upper extremities, right worse than left.The patent underwent x-rays of the lumbar spine, including flexion and extension views, showed the fusion at l3-4 was definitely solid.Flexion and extension views showed no motion, also indicated a solid fusion.Also, underwent x-rays of the cervical spine that showed very mild spondylosis at c3-4 and c4-5.On (b)(6) 2007, the patient presented with follow-up for cervical mri that showed a disc protrusion/bulge at c6-7.On (b)(6) 2011, the patient presented for a follow-up with complaints of lower back/l-spine problem.Problems: 1) displacement of lumbar intervertebral disc without myelopathy 2) degeneration of lumbar or lumbosacral intervertebral disc 3) spinal stenosis, lumbar region, without neurogenic claudication 4) cervical spondylosis without myelopathy.Review of systems showed abdominal pain and heartburns, muscle aches, muscle weakness, arthralgia, joint pain, back pain, swelling in extremities, numbness, frequent headaches and restless legs.The patient also underwent x-rays of thoracic spine that showed increased kyphosis, xrays of lumbar spine that showed solid fusion at l3-4 with a retained interbody cage and there was significant spondylosis at l2-3 with decreased disc height and some degeneration at l5-s1 and a lumbosacral mri showed a broad-based disc herniation with neural foraminal stenosis at l2-3.On (b)(6) 2013, the patient presented for a follow-up with complaints of back pain with radiations into the lower extremities with associated paresthesia and weakness.Problems: 1) displacement of lumbar intervertebral disc without myelopathy 2) degeneration of lumbar or lumbosacral intervertebral disc 3) spinal stenosis, lumbar region, without neurogenic claudication 4) cervical spondylosis without myelopathy.Review of systems showed back pain (lbp - affects bilateral sides) and swelling in the extremities, weakness, numbness and dizziness, depression, sleep disturbances and restless sleep, fatigues.The patient underwent x-ray of lumbar spine in ap and lateral view that showed a solid fusion at l3-4 with retained pedicle screw instrumentation.There was advanced collapse and degeneration of the l2-3 and l5-s1 disc spaces.There was a degenerative scoliosis with asymmetric collapse of the l4-5 disc space on the right and l5-s1 disc space on the left.On (b)(6) 2013, the patient presented for a follow-up of her mri.Problems: 1) displacement of lumbar intervertebral disc without myelopathy 2) degeneration of lumbar or lumbosacral intervertebral disc 3) spinal stenosis, lumbar region, without neurogenic claudication 4) cervical spondylosis without myelopathy.The patient underwent mri of lumbosacral with and without contrast that showed sign ificant degeneration at l5-s1 with collapse of disc space on the left.There was a disc bulge at l2-3.On (b)(6) 2013, the patient underwent a surgery with diagnosis of advanced collapse and degeneration, l5-s1 disk space with bilateral neural.Procedure: bilateral l5-s1 transforaminal epidural steroid injections under fluoroscopic guidance.No patient complications.On (b)(6) 2013, the patient presented for follow-up with complaints of pain and swelling in her left knee, dizziness, sleep disturbances and restless sleep.Physical examination showed diffuse tenderness.The patient underwent x-rays of left knee that showed no fracture, no dislocation, joint spaces well preserved, and normal alignment on (b)(6) 2013, the patient presented for follow-up with complaints 1) displacement of lumbar intervertebral disc without myelopathy 2) degeneration of lumbar or lumbosacral intervertebral disc 3) spinal stenosis, lumbar region, without neurogenic claudication 4) cervical spondylosis without myelopathy 5) pain in joint, lower leg.The patient underwent x-rays in ap and lateral views of lumbar spine that showed a solid fusion at l3-4 with retained pedicle screw instrumentation.There was right-sided collapse of the l4-5 disc space and left-sided collapse of to l5-s1 disc space.There was a mild scoliosis.

• 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 Key: 5055420
• MDR Text Key: 24997998
• Report Number: 1030489-2015-02205
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Attorney
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M115002AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2015
• 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: 127