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

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

Patient Problems Edema (1820); Unspecified Infection (1930); Muscle Spasm(s) (1966); Pain (1994)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2003: the patient presented stating he has had low back pain with radiation into lower extremities since 1981.The patient reports spasms and paresthesia in the legs.(b)(6) 2006: the patient was driving his truck and was hit by another vehicle.(b)(6) 2006: the patient underwent x-rays of the cervical spine due to pain in shoulder, neck and lower back and a recent motor vehicle accident.Impression: moderate degenerative disc changes and mild hypertrophic degenerative changes at c5-6 and c6-7.The patient underwent x-rays of the lumbar spine for the same reasons.Impression: advanced degenerative disc changes with some bilateral facet arthritic changes at l4-5 and l5-s1.The patient also underwent x-rays of the cervical spine.Impression: moderate degenerative disc changes and mild hypertrophic degenerative changes at c5-6 and c6-7.(b)(6) 2006: the patient underwent mri of the lumbar spine due to low back pain.Impression: at the l3-4 level, there is a large broad based disc bulge with a small paracentral disc extrusion which extends inferiorly, approximately 1 cm.This is resulting in mild to moderate bilateral neuroforaminal narrowing and a moderate degree of spinal stenosis, there is impingement upon the left l4 nerve root; at the l4-5 level, there is moderate to severe degenerative disc disease with acute degenerative endplate changes, there is also a broad-based disc bulge and bilateral facet hypertrophy resulting in moderate bilateral neuroforaminal narrowing and spinal stenosis; at the l5-s1 level, there is degenerative spondylosis resulting in moderate to severe bilateral neuroforaminal narrowing and mild to moderate spinal stenosis.(b)(6) 2006: the patient underwent ct of the chest with intravenous contrast.Impression: process involving primarily the right lower lobe is compatible with pneumonia, though follow up is advisable to confirm clearance after treatment, the features of the abnormality strongly suggest pneumonia over malignancy; old granulomatous disease; tiny indeterminate right upper lobe nodule, probably related to old granulomatous disease as well.(b)(6) 2006: the patient presented with low back pain.He also has severe left leg pain.X-rays show severe spinal stenosis at l4-5 and less so at l3-4 and less so still at l5-s1.All three levels are degenerative being worse at l4-5.His cervical films do show multi-level degenerative disc disease with protrusion.(b)(6) 2006: the patient underwent x-rays of the chest.Impression: status post open reduction and internal fixation of an old healed fracture of the left clavicle; no active chest disease.(b)(6) 2006: the patient presented for preoperative evaluation.Impression: asymptomatic for chest pain; negative exercise stress test per ekg criteria.(b)(6) 2006 : the patient presented with the following preoperative diagnoses: severe spinal stenosis at l4-5 and l5-s1; severe degenerative disc disease at l4-5 and l5-s1; mild spinal stenosis at l3-4.The patient underwent the following procedures: l4-s1 posterolateral spinal fusion; l4-s1 posterior instrumentation, legacy 5.5 titanium and x-10 crosslinks; right iliac crest grafts supplemented with rhbmp-2/acs bone graft supplement; emg stimulation and nim monitoring.Per the op notes, bone graft was placed in the lateral gutters.It was tubulized in a rhbmp-2/acs sponge.This along with copious autograft was placed in the lateral gutters from l4-s1 and into the facet joints.No patient complications were noted.(b)(6) 2006: the patient underwent ct of the lumbar spine due to back pain.Impression: patient is status post an l4-s1 posterior fusion with bilateral pedicle screws and rods.The left l5 pedicle screw extends along the superior endplate; decompressive laminectomies have been performed without evidence of spinal stenosis; there is moderate to severe degenerative disk disease at the l4-5 and l5-s1 levels, resulting in bilateral neural foraminal narrowing, worse at the l5-s1 level.(b)(6) 2006 : the patient presented for consult regarding his wound infection.Assessment: the patient is likely to have a staphylococcal edema, spine wound infection.(b)(6) 2007: the patient presented with worsening posterior cervical pain and pain radiating down with bilateral numbness and tingling.It is mostly the right arm in which it radiates down to the hand with numbness and tingling in all fingers in a c6-7 distribution.This is secondary to severe cervical spondylosis and degenerative collapse at c4-5 and c6-7 seen by his previous x-rays.(b)(6) 2007: the patient presented with preoperative diagnoses of cervical spondylosis.The patient underwent the following procedures: anterior cervical discectomies and allograft bone graft fusions at c4-5, c5-6, and c6-7 using a cornerstone allograft bone graft and osteofil; placement of an anterior cervical plate from c4-c7, zephyr plate.(b)(6) 2007: the patient presented with a little swallowing problem but he is better as his swelling has decreased postoperatively.(b)(6) 2007: the patient presented with increasing pain from the neck to the shoulder on the left side.Assessment: muscle spasm of the trapezius; post-laminectomy syndrome of the lumbar spine; history of cervical spinal stenosis; status post anterior cervical discectomy and fusion now with possible fusion failure.(b)(6) 2009: the patient presented with some leg pain.(b)(6) 2009: the patient underwent x-ray of the elbow.Impression: no acute osseous abnormality; mild degenerative arthropathy.The patient underwent x-rays of the knee.Impression: subcutaneous soft tissue swelling in the superficial prepatellar region.Left knee series otherwise negative.(b)(6) 2009: the patient presented following getting hit by a truck.The patient was thrown to his knees and has developed leg pain in both legs.Assessment: likely baker cyst; knee pain.(b)(6) 2009: the patient underwent mri of the right knee after being struck by an automobile.Impression: large bucket handle type radial tear involving the body and posterior horn of the lateral meniscus.There is linear abnormal signal in the posterior horn of the medial meniscus consistent with a transverse tear.Small joint effusion.Moderate thinning of the articular cartilage in the patellofemoral and lateral compartments of the knee joint.(b)(6) 2010 : the patient presented with low back pain.His medications are helping with his spasms.Assessment: lumbago; post-laminectomy syndrome.(b)(6) 2010: the patient presented with bilateral knee pain.Assessment: osteoarthritis, right and left knee, lateral compartment.(b)(6) 2010: the patient underwent x-rays of the both knees due to osteoarthritis.Findings: bilateral knee osteoarthritis with lateral joint line narrowing and patellofemoral narrowing.(b)(6) 2010: the patient presented with bilateral hip and leg pain.(b)(6) 2010: the patient presented with low back pain and bilateral leg pain.Assessment: lumbago; post laminectomy syndrome; knee pain (b)(6) 2010: the patient presented with left knee osteoarthritis.The patient underwent a left total knee arthroplasty.(b)(6) 2011: the patient present presented with low back pain and right lower extremity radicular pain.Assessment: post -laminectomy syndrome of the lumbar spine; lumbago; lumbar radiculitis; bilateral knee osteoarthritis status post knee replacement.(b)(6) 2011: the patient underwent intralaminar lumbar epidural steroid injection due to pls lumbar with lumbar radiculitis.No patient complications were noted.(b)(6) 2011: the patient underwent lumbar transforaminal steroid injection at l3 on the left.No patient complications were noted.(b)(6) 2011: the patient presented with chronic low back pain.Assessment: post-laminectomy syndrome; chronic lumbago.(b)(6) 2012: the patient presented with low back pain with bilateral radiation, worse on the right side.Assessment: left shoulder pain; post-laminectomy syndrome of the lumbar spine; chronic lumbago.(b)(6) 2012: the patient underwent x-rays of the left shoulder due to non-traumatic shoulder pain.Impression: post-op changes; no acute abnormality.(b)(6) 2012: the patient presented with low back pain and lower extremity radicular pain.Assessment: post-laminectomy syndrome of the lumbar spine; lumbar radiculitis.(b)(6) 2012: the patient underwent a transforaminal steroid injection at l3 on the right.No patient complications were noted.(b)(6) 2012: the patient presented with some continued low back pain without any radiation.Assessment: lumbar post laminectomy syndrome; lumbago; osteoarthritis of the lower leg.(b)(6) 2012: the patient presented stating his back pain is doing fairly well.Assessment: postlaminectomy syndrome of the lumbar spine; chronic lumbar neuritis; lumbago.(b)(6) 2012: the patient presented for x-rays of the chest due to persistent cough.Impression: no acute pulmonary disease.

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.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4207705
• MDR Text Key: 4964293
• Report Number: 1030489-2014-04150
• 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
• Type of Report: Initial
• Report Date: 09/29/2014

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: 09/29/2014
• Initial Date FDA Received: 10/28/2014
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80