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

Catalog Number 7510600

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

Patient Problems Neuropathy (1983); Weakness (2145); Tingling (2171); Sinus Perforation (2277); Numbness (2415)

Event Type  Injury  

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.

Event Description

Per medical records it was reported that on (b)(6) 2011: per office notes, patient has low back pain since she has returned to work.Musculoskeletal examination reveals that pain reproduces with both flexion and extension.(b)(6) 2011: patient presented for visit.Visit diagnosis: spondylolisthesis, motor vehicle collision, sprain lumbosacral.(b)(6) 2011: patient presented for office visit due to lower back and leg pain.Mri study demonstrates foraminal stenosis secondary to lumbar spondylolisthesis at l4-5.(b)(6) 2011: patient presented for preoperative consultation.Pertinent medical conditions include gerd.She complains of back pain which is described as chronic.Diagnosis include: esophageal reflux and allergic rhinitis cause unspecified.(b)(6) 2011: patient presented with following pre-op diagnosis: l4-5 spondylolisthesis with spinal stenosis and underwent following procedures: 1.L4 laminectomy with decompression.2.L5 laminectomy with decompression.3.L4-l5 posterior spinal fusion.4.L4-l5 pedicle screw instrumentation utilizing the globus pedicle screw system.5.Use of bone morphogenic protein sponge - prosthetic device.6.Cancellous allograft bone.Indications for procedure: patient is involved in a motor vehicle accident resulting in lower back pain and right lower extremity complains of pain.She was tried with conservative treatment for over a year with incomplete relief of her pain complaints.X-rays demonstrated spondylolisthesis at l4-l5, which was degenerative in variety.There was also stenosis noted on her mri study.Per op notes:".Laminectomy was performed at l4 and l5.Lateral recess decompression was carried out by way of partial medial facetectomies as well as limited foraminotomies.The l4 and l5 nerve roots were identified and completely followed on through the foramina and completely decompressed.The lateral recess was more compressed on the right side than the left side.The wound was then irrigated with antibiotic solution.At this time, a bone morphogenic protein sponge was soaked on the back table.Cancellous allograft bone was rolled within the sponge.Fusion was completed by way of decortication of the transverse processes at l4 and l5 as well as the lateral border of the superior articular facet of l4 as well as facet joint of l4-l5.Bone graft material was then placed into lateral gutters from l4 to l5.A titanium rod was then placed within the pedicle screws.They were then top loaded, top tightened, and torqued off in the usual fashion.The patient's wound was irrigated every 30 minutes for purposes of lowering the risk of infection." no complications were noted.(b)(6) 2011: patient underwent x-ray of lumbar spine due to pain.Impression: no change in the spondylolisthesis at l4-5 after laminectomy and fusion.No evidence of fracture.One l5 pedicle screw projects through the anterior cortex of the l5 vertebral body.(b)(6) 2011: patient was discharged.(b)(6) 2011: patient presented for follow-up.Visit diagnosis: post laminectomy syndrome: cervical.The patient complains of some axial back pain.She has some degree of stiffness.Review of system reveals that patient is positive for night sweats, myalgias,back pain and numbness and tingling.(b)(6) 2011: patient presented for visit due to back pain and leg pain.Visit diagnosis: post laminectomy syndrome: lumbar.Patient is having intermittent pain down the right leg.Review of system reveals that patient is positive for headaches, sinus pain, myalgias,back pain, joint pain, and numbness and tingling.(b)(6) 2012: patient presented for visit due to low back pain, leg and foot pain.Visit diagnosis: post laminectomy syndrome: lumbar.(b)(6) 2012: patient presented for visit due to low back pain, leg and foot pain.Visit diagnosis: post laminectomy syndrome: lumbar.Patient states that topomax is causing her to have burning sensation in her eyes.The patient does complain of pain with side bending to the right as well as extension to the spine.Review of x-rays reveals patient is having grade 1 spondylolisthesis.(b)(6) 2012: patient presented for visit due to low back pain.Visit diagnosis: lumbago, post laminectomy syndrome: lumbar.Patient is having les and back pain which is described as burning, shooting and stabbing and associated with numbness, weakness and tenderness.Review of system reveals patient is positive for weight gain, myalgias,back pain, joint pain, numbness/tingling.(b)(6) 2012: patient presented for visit due to low back pain, leg pain, foot pain along with numbness and tingling.Visit diagnosis: post laminectomy syndrome: lumbar.Review of system reveals patient is positive for night sweats, back pain,headaches, myalgias, joint pain, numbness/tingling.(b)(6) 2012:patient presented for office visit with diagnosis of s/p lumbar fusion.Her work status is noted as "able to perform limited duty." (b)(6) 2013: patient presented for an office visit due to hip pain.Visit diagnosis: lumbago, post laminectomy syndrome: lumbar.Patient complains of pain over the right side of her back with radiation into the buttock, lateral aspect of thigh, and into her toes, especially on standing and walking.She also describes paraesthesias along with pain as well.The patient had tenderness to palpation over the right side of her low back and over the spinous processes and bilat paraspinous area.Straight leg was positive on the right side with pain radiating down to her toes and dermatome of l5.Impression: patient with post-lumbar laminectomy syndrome with ongoing possible right l5 radicular pain.1) post-lumbar laminectomy syndrome.2) obesity.3) chronic opioid therapy.Review of system reveals patient is positive for night sweats, heartburn,sinus pain,headaches, numbness/tingling.(b)(6) 2012: patient presented for visit due to low back pain.Visit diagnosis: lumbago, post laminectomy syndrome: lumbar (b)(6) 2013: patient presented for epidural steroid injection due to post-lumbar laminectomy syndrome with right l5 radiculitis.(b)(6) 2013: patient presented for visit due to low back pain.Visit diagnosis: lumbago, post laminectomy syndrome: lumbar.Review of system reveals patient is positive for night sweats, heartburn,weakness ,tinnitus, myalgias, joint pain, numbness/tingling.(b)(6) 2013: patient presented for epidural steroid injection.(b)(6) 2013: patient presented for visit due to low back pain.Visit diagnosis: lumbago, post laminectomy syndrome: lumbar.Patient still has low back and bilateral lower extremity pain on standing and ambulation.Assessment:patient with chronic low back and bilateral lower extremity pain secondary to post lumbar laminectomy syndrome, opiate dependence, status post lumbar epidural steroid injections.Review of system reveals patient is positive for night sweats, sinus pain, myalgias, joint pain, numbness/tingling ,insomnia.(b)(6) 2014: patient presented for an office visit for routine medical examination.Diagnosis: esophageal reflux.(b)(6) 2014: patient presented for an office visit due to low back pain, leg and hip pain.Visit diagnosis: post laminectomy syndrome: lumbar.Patient still has low back and bilateral lower extremity pain on standing and ambulation.Assessment: post lumbar laminectomy syndrome obesity, opioid dependence.Review of system reveals patient is positive for night sweats, heartburn, joint pain, numbness/tingling.

• 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: 5059580
• MDR Text Key: 25109024
• Report Number: 1030489-2015-02222
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Catalogue Number: 7510600
• Device Lot Number: M111052AAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2011
• 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: 80