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 Fall (1848); Loss of Range of Motion (2032); Weakness (2145); Stenosis (2263); Inadequate Pain Relief (2388); Neck Pain (2433); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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

It was reported that on (b)(6) 2005, the patient underwent anterior lumbar interbody fusion from vertebrae l4 to s1 and also underwent posterior spinal fusion surgery from vertebrae l4 to l5 on (b)(6) 2005 using rhbmp-2 and collagen sponge.Post-op complications: progressively worsening and chronic back pain, with pain, weakness and radiculopathy in legs.As a result patient had suffered falls.The patient was unable to twist, bend, reach, or lift without pain.The patient was used to be very active and strong and could not participate in sports and hobbies as the patient was enjoying prior to surgery.Sexual intercourse was also painful.Severe pain and symptoms compelled the patient to underwent revision surgery.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

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) 2005: patient was discharged from the hospital.On (b)(6) 2015: patient underwent myelogram and ct myelogram of the lumbar spine.Comparison study was done from a ct myelogram dated (b)(6) 2006.Impression: six non rib bearing lumbar type vertebral bodies; stable anterior and posterior lumbar fusion spanning from l5 through the sacrum without evidence of hardware loosening or failure.The canal and neuroforamina appear patent; stable lumbar spondylosis changes at l1-l2 through l4-5 with perhaps slight interval increase in degenerative disk expansible changes at l3-l4 and l4-l5 but without significant canal stenosis or neuroforaminal narrowing.There is no acute fracture or subluxation.There is no hardware loosening or failure.

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) 2005: per billing records, patient underwent ct of lumbar spine without contrast.On (b)(6) 2005: per billing records, patient underwent ekg test.On (b)(6) 2005: per billing records, patient underwent x-ray of lumbar spine.On (b)(6) 2006: per billing records patient underwent some radiological tests.On (b)(6) 2006:per billing records, patient underwent ct of thoracic spine with contrast, lumbar spine with contrast.

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) 2010: the patient underwent ct of sinus facial due to facial pain and sinusitis.Impression: chronic right frontal, bilateral ethmoid, bilateral maxillary and sphenoid rhinosinusitis.On (b)(6) 2011: the patient underwent echocardiogram due to shortness of breath.Impression: normal left upper size and systolic function with stage 1 distolic dysfunction; no significant valvular disease present.On (b)(6) 2010, (b)(6) 2012: the patient underwent analog screening of bilateral mammogram.Impression: no suspicious lesion.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on, (b)(6) 2007: the patient presented with a complaint of pain down to the lower extremities.On (b)(6) 2007: the patient presented for follow-up visit.On (b)(6) 2007, the patient presented for medication management.On (b)(6) 2008: the patient presented with a complaint of pain down to lower extremities.On (b)(6) 2008: the patient underwent mri of the lumbar spine without contrast due to lumbago and disorders of sacrum.Impression: there is a levoconvex scoliosis.At l5-s1, a concentric disc bulge and moderate facet arthropathy is seen.There is moderate to severe bilateral foraminal stenosis.There is a broad-based left foraminal disc protrusion measuring 2 mm abutting the exiting left l5 nerve root which appears new compared to the previous exam.At l4-l5, a concentric disc bulge and moderate facet arthropathy is seen.There is a broad based left foraminal disc protrusion contributing to moderate left foraminal stenosis and abutting the exiting left l4 nerve root.The disc protrusion measures 4 mm.There is moderate facet arthropathy and mild canal stenosis.At l3-l4, a concentric disc bulge and moderate facet arthropathy is demonstrated.There is broad-based left foraminal disc protrusion measuring 4 mm with mass effect on the left l3 nerve root.There is moderate to severe degenerative disc disease.These findings appear worsened compared to the previous exam.At l2-l3, a concentric disc bulge and mild facet arthropathy is demonstrated.There is a broad based left lateral disc protrusion measuring 3 mm.There is mild central canal stenosis.These findings were essentially stable.On (b)(6) 2008: the patient was pre-operatively diagnosed with low back pain and sacroiliac joint arthropathy and underwent the following procedures: left sacroiliac joint injection.Lumbar transforaminal epidural injection, bilateral l5-s1.On (b)(6) 2008: the patient presented with a complaint of back pain.On (b)(6) 2008: the patient presented for a follow-up visit due to back pain.On (b)(6) 2008: the patient was pre-operatively diagnosed with low back pain and underwent selective nerve root block right l5 and s1.On (b)(6) 2008: the patient presented for medication refilling.On (b)(6) 2008: the patient was pre-operatively diagnosed with si joint arthropathy and low back pain and underwent right sacroiliac radiofrequency ablation.On (b)(6) 2009: the patient presented with a complaint of pain on left facet area.On (b)(6) 2009: the patient was pre-operatively diagnosed with low back pain with si joint arthropathy and failed back syndrome and underwent left sacroiliac joint radiofrequency ablation.On (b)(6) 2009: the patient was pre-operatively diagnosed with low back pain and facet arthropathy and underwent lumbar facet joint injection, left l4-l5, l5-s1.On (b)(6) 2009: the patient was pre-operatively diagnosed with low back pain with facet arthropathy, degenerative disc disease and failed back syndrome and underwent the lumbar facet joint injection left l2-l3, l3-l4.On (b)(6) 2009: the patient presented with pain at the left paralumbar area.On (b)(6) 2009: the patient was pre-operatively diagnosed with lumbar degenerative disc disease with si joint arthropathy and underwent right sacroiliac joint radiofrequency ablation.On (b)(6) 2009: the patient presented with a complaint of a lot of pain in the back and also down to the right lower extremity, posterior thigh and the calf area.On (b)(6) 2011: the patient presented with a pre-op diagnosis of bilateral sacroiliac joint pain and underwent bilateral si joint blockade with contrast study of each si under fluoroscopy.On (b)(6) 2011: the patient was pre-operatively diagnosed with lumbago/lumbar facet syndrome and underwent the bilateral l4-l5, l5-s1 f acet block with contrast study of each facet under fluoroscopy.On (b)(6) 2010, (b)(6) 2011: the patient presented with a chief complaint of low back pain.On (b)(6) 2011: the patient was pre-operatively diagnosed with lumbago/lumbar facet syndrome and underwent bilateral l3-l4, l4-l5 facet block with contrast study of each facet under fluoroscopy.On (b)(6) 2009, (b)(6) 2011: the patient presented for pain management.On (b)(6) 2011: the patient presented for follow-up visit due to low back pain.On (b)(6) 2011: patient presented with chief complaints of thoracolumbar spine pain with persistent right leg pain and foot pain.On (b)(6) 2011: the patient presented with a chief complaint of neck and low back pain.On (b)(6) 2012: the patient presented with a complaint of back pain.On (b)(6) 2012: the patient presented with a chief complaint of low back pain down to the right.On (b)(6) 2012: the patient was pre-operatively diagnosed with lumbar degenerative disc disease with radiculopathy and underwent lumbar transforaminal epidural right l4-l5, l5-s1.On (b)(6) 2012: the patient presented for medication management.On (b)(6) 2012: patient was presented for office visit due to back pain.On (b)(6) 2012: patient presented with chief complaints of left shoulder pain and low back pain.On (b)(6) 2012: the patient underwent mri of the left shoulder due to pain in joint involving shoulder region.Impression: there is marked tendinosis distal aspect supraspinatus tendon.There is partial intrasubstance tearing of a small percentage of the fibers estimated at 30 % or less of the expected thickness of the supraspinatus tendon.There is type ii acromion and a moderate sized inferior osteophyte at the acromioclavicular joint which does touch and efface the supraspinatus musculotendinous junction.This can occur in concert with the shoulder impingement syndrome.There is subdeltoid bursitis.On (b)(6) 2012: patient was presented for office visit for medication management.On (b)(6) 2012: patient presented for mri on imaging study review.Impression:1.History of lumbar fusion with adjacent segment bulging annuli at l3-4.2.Degenerative disk disease t11 to l2 with left para central disk protrusion type herniation with extruded fragment.3.Left knee pain with chondromalacia of the patella grade 3 in nature.On (b)(6) 2012: the patient underwent mri of the lumbar spine without contrast.Impression: the patient is status post laminectomy and fusion from l4 through s1, and there are interbody fusion devices and fusion grafts.The metal hardware at the l5-s1 level obscures the anatomic detail of the central canal and foramina which cannot be fully assessed.L5-s1: there is mild facet arthropathy and post-surgical changes posteriorly.The central canal and foramina cannot be assessed due to the metal artifact.L3-4: a concentric disc bulge, mild facet arthropathy, and mild degenerative spondylosis is seen contributing to mild bilateral foraminal stenosis.T12-l1: a concentric disc bulge, 3 mm posterior disc protrusion, and moderate degenerative spondylosis is seen with mild effacement of the ventral csf.The patient also underwent mri of the right knee due to pain in joint site unspecified.Impression: the menisci and cruciate ligaments are intact.There is small joint effusion.Grade iii chondromalacia patellae are demonstrated.Mild edema is seen in hoffa¿s fat pad which may reflect patellofemoral syndrome and a maltracking patella.On (b)(6) 2013: patient was presented for office visit due to back pain, increasing lower extremity dysesthesias and cramping.On (b)(6) 2013: patient was presented for office visit.On (b)(6) 2013: patient presented for review of diagnostic studies.Impression: acquired kyphosis secondary to degenerative disk disease and spondylosis in the thoracic spine, t10 to l3 with questionable superior endplate compression t11-t12.Stable l4-l5 fusion.Stable mechanical disk replacement, l5-s1.On (b)(6) 2013: patient was presented for office visit for pain management.On (b)(6) 2013: patient presented with chief complaints of low back pain and right knee pain.On (b)(6) 2013: patient presented with chief complaints of thoracolumbar spine pain.On (b)(6) 2013: patient presented for pain in the back down to the right lower extremity.On (b)(6) 2013: patient was pre-operatively diagnosed with thoracic degenerative disc disease and underwent thoracic transforaminal epi dural, left t11-t12, t12-l1.No patient complications were reported.On (b)(6) 2013: patient presented for follow up for post surgery.On (b)(6) 2013: patient presented with chief complaints of thoracolumbar spine pain with some leg pain also.On (b)(6) 2013: patient was pre-operatively diagnosed with lumbar degenerative disc disease with radiculopathy and underwent lumbar transforaminal epidural, right l5-s1 s1 procedure.No patient complications were reported.On (b)(6) 2013: the patient underwent mri of the lumbar spine without and with contrast due to degenerative lumbar/lumbosacral iv disc.Impression: post surgical changes of l4 through s1 fusion, as above.No significant change in appearance of the lumbar spine when compared to the study of (b)(6) 2012.T12-l1: there is a 3 mm central disc protrusion which mildly effaces the ventral thecal sac, but does not result in central canal stenosis.The neural foramina are normal.These findings are unchanged.L3-4: there is mild degenerative spondylosis, a mild diffuse disc bulge, and mild bilateral facet arthropathy which results in mild bilateral neural foramina, stenosis.These findings are unchanged.The central canal is normal.L4-5: there are post surgical changes of posterior and interbody fusion with laminectomy.The central canal and neural foramina are patent.These findings are unchanged.On (b)(6) 2013: patient presented with chief complaints of low lumbar spine pain, right leg pain and foot pain, as well as now right shoulder pain.On (b)(6) 2013: patient presented with chief complaints of low back pain, right leg pain.On (b)(6) 2014: patient presented with chief complaints of cervical neck pain, right upper extremity dysesthesias, low back pain, and right leg pain.On (b)(6) 2014: the patient underwent mri of cervical spine without contrast due to degeneration cervical iv disc.Impression: c2-3: t here is a mild diffuse disc bulge but no central canal or neural foramina stenosis and no significant change.C4-5: there is a 2 mm central disc protrusion which effaces the ventral thecal sac and is slightly larger when compared to the prior study.The central canal remains within normal limits with an ap dimension of 11 mm.The neural foramina are normal.C5-6: there is a new, 2 mm, broad based central disc protrusion which effaces the ventral thecal sac and results in mild central canal stenosis.).The ap dimension of the thecal sac is 9 mm.The neural foramina are within normal limits.On (b)(6) 2014: patient presented with chief complaints of cervical neck pain, right upper extremity dysesthesias.On (b)(6) 2014, (b)(6) 2015: patient presented with chief complaints of neck and back pain.On (b)(6) 2015: patient presented with chief complaint of right clinical l5-s1 radiculopathy 80%, and back pain 20%.On (b)(6) 2016: the patient underwent mri joint of lower extremity without contrast right knee due to history of pain.Impression: minimal joint effusion.Other evidence of internal derangement is not confirmed, signal within the posterior horn of the medial meniscus may represent degenerative change, although a small completed meniscal tear cannot be entirely ruled out.On (b)(6) 2015: patient presented for office visit and diagnosed with upper extremities, back pain.On (b)(6) 2015: patient presented for office visit for medication refill and back pain.On (b)(6) 2015: patient was pre-operatively diagnosed, chronic low back pain.Chronic lumbar radiculopathy and underwent transforaminal right- sided l5-s1 epidural steroid injection.No complication reported.On (b)(6) 2015: patient presented for office visit for medication refill back pain.On (b)(6) 2015: patient presented for office visit due to post op follow-up (low back pain, osteoporosis, lumbar radiculopathy).On (b)(6) 2015: patient presented for office visit due to follow- up and wound check.On (b)(6) 2016: patient presented for office visit due to med refill and follow- up.

• 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: 5382372
• MDR Text Key: 36464158
• Report Number: 1030489-2016-00219
• 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,Followup,Followup,Followup,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• 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
• Date Manufacturer Received: 12/20/2016
• 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 Age: 47 YR