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

Catalog Number 7510200

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

Patient Problems High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Burning Sensation (2146); Stenosis (2263); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(disc herniation, leg pain).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.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) 2009: the patient was preoperatively diagnosed with spondylolisthesis status post laminectomy and underwent following procedures: posterior re-exploration of lumbar laminectomy and fusion from l4-s1; fusion posterolateral l4-s1 using allograft and rhbmp-2; pedicel screw fixation l4-s1 using screw system; navigation.As per op-notes: "bone graft was obtained mixed with rhbmp-2 and allograft and placed at l4-s1.Rods were positioned and reduction of spondylolisthesis was carried out using the crickets on the l5 screw¿.The patient also underwent post-op fluoroscopy.Impression: orthopedic hardware is seen in the distal lumbar spine.Orthopedic devices are noted between l4, l5 and l5-s1." on (b)(6) 2009: the patient underwent x-ray of spine post op.Impression: pedicle screws noted at levels of l4-s1.The bone alignment is adequate.On (b)(6) 2011: the patient underwent mri scan of lumbar spine.Impression: there is previous l4-l5 and l5-s1left hemilaminectomy is with discectomies and probable placement of disc space maintainers.There are also bilateral short harrington rods stabilizing the vertebral bodies and posterior appendages from l4 to s1; l5-s1 also has 4mm of grade 1 anterior spondylolisthesis in association with slight bulging of residual disc material an moderate bony stenosis of bilateral l5 foramina, left greater than right; l4-l5 had bulging of the annulus fibrosus with degenerative changes in the posterior elements; there is moderate spinal stenosis and bilateral l3 foramen stenosis due to combination of bulging annulus fibrosis and degenerative hypertrophic changes in the posterior appendages; there are degenerative changes with dessication of the l1-l2 and l2-l3 discs, each showing bulging of the annulus fibrosis.Also note a posterior midline annular tear in the l1-l2 disc.On (b)(6) 2011: the patient was preoperatively diagnosed with l3-l4 stenosis status post spine instrumentation and underwent following procedures: re-exploration of fusion; removal of old instrumentation; refusion using allograft; decompressive laminecto my and facetectomy at l3-l4 level.On (b)(6) 2011: the patient underwent anterior posterior , lateral neutral, lateral flexion and extension x-rays.Impression: interval removal of posterior stabilization hardware l4-s1.No evidence of spondylolisthesis or dynamic instability.On (b)(6) 2011: the patient presented with numbness in the left foot, burning in the sole of the foot and difficult when he moves his back.On (b)(6) 2012: the patient underwent lumbar spine radiographs due to low back pain and status post surgery.Impression: interbody fusions noted at l4-l5 and l5-s1.L4 and l5 laminectomy defects are again noted.Alignment is unchanged.Mild degenerative changes are again noted.On (b)(6) 2013: the patient presented with constant pain, cramping in his lower back, burning pain in the back of his calf and band like pain of the left leg.On (b)(6) 2013: the patient presented with a chief complaint of low back pain and neck pain.The patient was diagnosed with lumbar sprain, spine lumbar fusion, lumbar radiculopathy, and lumbar spondylolisthesis.On (b)(6) 2013: the patient presented for follow up after injection.On (b)(6) 2013: the patient underwent lumbar epidurial steroid injection under fluoroscopic guidance.

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) 2015: patient underwent mri brain without contrast.Impression: mild chronic microvascular white matter ischemic changes.No evidence of recent infarct, mass or hemorrhage.

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) 2009, (b)(6) 2010: patient presented for follow-up with persistent dysesthesia in area of left thigh and left foot.On (b)(6) 2010, (b)(6) 2011: patient presented for follow-up visit.Physical examination revealed evidence of moderate bilateral vertebral spasm in the cervical and lumbo-sacral regions, with moderately diminished range of motion.Impression is that of a causally-related lumbo sacral, musculo-skeletal and radicular pain syndrome.On (b)(6) 2011, (b)(6) 2012: patient presented for follow-up visit post hardware removal with complaint of diminished mechanical lumbo-sacral pain.Impression is that of a causally-related lumbo sacral, musculo-skeletal and radicular pain syndrome.On (b)(6) 2012: patient presented for follow-up visit post hardware removal with complaint of diminished mechanical lumbo-sacral pain.Impression is that of a causally-related lumbo sacral, musculo-skeletal and radicular pain syndrome.Physical examination revealed operative incision is benign and well healed.Also, evidence of moderate bilateral vertebral spasm in the cervical and lumbo-sacral regions, with moderately diminished range of motion.Impression is that of a causally-related lumbo sacral, musculo-skeletal and radicular pain syndrome.On (b)(6) 2013: patient presented for neurosurgical evaluation with recurrent lumbo-sacral and radicular pain.Repeat mri of lumbar spine showed a juxtaposed level stress with lateral recess stenosis with impingement at the l3/4 level.On (b)(6) 2013 patient admitted to hospital due to lower back pain radiating to legs.On (b)(6) 2013 patient underwent chest pa <(>&<)> lat due to hypertension and pre-op.

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) 2009: patient was admitted to the hospital.On (b)(6) 2009: the patient underwent x-ray of spine post op.Impression: pedicle screws noted at levels of l4-s1.The bone alignment is adequate.Patient underwent ct lumbar spine without contrast.Impression: lesion with the right iliac bone.This is incompletely visualized on the prior examinations.However, the overlying cortex is intact raising suspicion for other etiologies.If this is not the harvesting site, a bone scan should be performed to further evaluate.On (b)(6) 2009: patient was discharged.On (b)(6) 2012, (b)(6) 2013,the patient presented for an initial physiatric evaluation of a work injury sustained on (b)(6) 1994.Examination of lumbar spine: healed scar from t10 through l5-s1.More prominent midline tenderness from l1 through l5-s1 juncture, bilateral para-lumbar tenderness and tightness, bilateral sacro-iliac joint tenderness, positive upper gluteal and piriformis tenderness and tightness noted.Examination of thoracic spine: positive bilateral upper trapezius, levator scapulae and rhomboidal tenderness and tightness noted, midline tenderness from t1 through t12.The patient underwent physical examinations.Impression: status post cervical laminectomy, facectomy at c4-5, c5-6 to full laminectomy at c5, status post lumbar fusion at l4-5 and l5-s1 with recent mri of the lumbar spine showing post-operative changes at l4-5 and l5-s1 significant central stenosis at l3-4 due to bulging and facet arthropathy with moderate bilateral foraminal compromise and mild central stenosis at l2-3 due to diffuse bulging and small central herniation, status post recent removal of screw, cervical, thoracic and lumbar myofascitis and signs of cervical and lumbar radiculitis.Cat scan of the lumbar spine on (b)(6) 2013 showed abscess of solid posterior bony fusion at l5-s1 with posterior disc protrusion at l3-4, recent ¿ncv/emg¿ testing of the upper and lower extremities on (b)(6) 2013 positive for re-innervation due to right c5 radiculopathy, mild left cubical tunnel syndrome, unobtainable h-reflex in the right suggestive of s1 radiculopathy and cervical, thoracic and lumbar myofascitis.Neurogenic bowel and bladder with ileus post-operatively.Bulging discs at t11-12 and t12-l1, new, left lateral herniation at l1-2 with impingement on the exiting l1 nerve root.On (b)(6) 2012: the patient underwent mri of the lumbar spine without and with contrast due to back pain radiating to the left hip.Conclusion: post-operative changes at l4-5 and l5-s1, foraminal compromise without central stenosis, significant central stenosis at l3-4 due to bulging and facet arthropathy, moderate bilateral compromise, mild central stenosis at l2-3 due to diffuse bulging and small central herniation.On (b)(6) 2012: the patient presented for an office visit with chief complaints of lumbar pain, pain radiating into both lower extremities, burning sensation on the left and right extremities getting extremely worse.The patient underwent physical examinations.Impression: status post cervical lobectomy, facectomy at c4-5 and c5-6, laminectomy at c5, status post lumbar fusion at l4-5 and l5-s1 revision, removal of screw a year ago, cervical, thoracic and lumbar myofascitis and signs of cervical and lumbar radiculitis.A recent mri report indicated post-operative changes at l4-5 and l5-s1, foraminal compromise at these levels without central stenosis, significant central stenosis at l3-4 due to bulging and face atrophy, there was also moderate bilateral foraminal compromise central stenosis at l2-3 diffuse bulging and small central herniation.On (b)(6) 2013: the patient presented for an initial physiatric evaluation of a work injury sustained on (b)(6) 1998.The patient underwent physical examinations.Impression: status post facial contusion, ¿tmj¿ dysfunction, ocular contusions and injuries, left side more than the right, post-traumatic headaches.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5687728
• MDR Text Key: 46159523
• Report Number: 1030489-2016-01587
• 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: 10/27/2016

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: 08/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110804AAJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 10/27/2016
• Supplement Dates FDA Received: 07/08/2016; 07/25/2016; 09/07/2016; 11/16/2016; 09/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2009
• 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: 82