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 Muscle Spasm(s) (1966); Neuropathy (1983); Pain (1994); Tachycardia (2095); Tingling (2171); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2008, the patient underwent a mri which showed significant changes along the l3-4, l4-5 segment as well as an annular tear along the posterior l5-s1, posterior bulging at l5-s1, minimal encroachment on the anterior aspect of the thecal sac at l4-5, right > left which resulted in a moderate right-sided foraminal narrowing.On (b)(6) 2008, reportedly, the patient underwent x-rays of the lumbar spine which showed moderate scoliosis of the thoracolumbar spine extending form the superior endplate of t10 to the inferior endplate of l2, 15° scoliosis.On (b)(6) 2009 the patient presented with low back pain, left leg radiculopathy with associated numbness and tingling.The patient underwent a laminectomy decompression l3-4 and l4-5; posterior lumbar interbody fusion l4-5; posterior spinal fusion l3 to l5, posterior spinal segmental instrumentation l3 to l5; allograft, autograft, and use of rhbmp-2.Per the operative report¿ ¿ the transverse processes were decorticated and bone graft was placed within the lateral disc.This was followed by placing the rhbmp-2 sponges in the firth and lateral gutters.¿¿ x-rays were utilized intra-operatively for verification.Screws were stimulated an all amplitude looked good.No patient complications were reported.Depuy implants.On (b)(6) 2009 the patient developed a tachycardia.On (b)(6) 2009 the patient was discharged from hospital.The tachycardia had not resolved but symptomatically the patient was feeling better.On (b)(6) 2009, approx.One month post op, the patient presented with increased back pain and spasm and pain as well as subjective numbness into the left leg.The patient felt they may have over done it the day before.Overall, the patient felt they were improving.Between (b)(6) 2009 and 2013 the patient underwent multiple chiropractic treatments.In a (b)(6) 2009 dated (b)(6) physicians progress report, it was noted that the patient presented with moderate right neck and shoulder pain with stiffness; moderate/slight low back pain, left > right; and reduced left leg pain into the thigh and calf.The patient reported one episode of severe back stiffness.The back and neck oswestry score was 30 before treatment.On (b)(6) 2009, approx.3.5 month post op, the patient presented with numbness in buttock on the left side otherwise reported to be well.Imaging showed evidence of good bony formation with the hardware pedicle screw fixation intact.Medications: flexeril and norco.In a (b)(6) 2009 dated (b)(6) physicians progress report, it was noted that the patient presented with right neck and shoulder pain with stiffness and moderate left side low back pain after starting physical therapy.The patient also had left leg pain and numbness into the left thigh and calf area.The back and neck oswestry score was 52 before treatment.The patient was listed as permanent disability (pd).In a (b)(6) 2009 dated (b)(6) physicians progress report, it was noted that the patient presented with complaints of right neck and shoulder pain with stiffness and low back pain with improving stiffness.There was improved pain in the left leg, thigh and calf.Per the report , the (b)(6) surgery appeared ¿successful¿.In a (b)(6) 2009 dated (b)(6) physicians progress report, it was noted that the patient presented with complaints of increased severe low back stiffness and pain.The back and neck qswestry index score of 52 before treatment.The patient reported the pain had worsened on (b)(6) 2009 after a day trip.The patient reported difficulty with sleep, sex life, and social life secondary to pain.In a (b)(6) 2010 dated (b)(6) physicians progress report, it was noted that the patient presented with increased constant sharp right side low back pain with difficulties sleeping, sitting and walking.The patient reported difficulty with sleep and activities of daily living secondary to pain.In a (b)(6) 2010 dated (b)(6) physicians progress report, it was noted that the patient presented with increased moderate right side sharp low back pain with severe stiffness; difficulty walking; difficulty bending at the waist; decreased cervical rom, and cervical stiffness and achiness.The patient described the low back pain as worsening daily and severe and stated that ¿everything i do causes severe pain.¿ the patient reported difficulty with sleep, sex life, social life, and activities of daily living secondary to pain.They also reported that medications helped but very little.In a (b)(6) 2011 dated (b)(6) physicians progress report, it was noted that the patient presented with severe low back stiffness and pain after having had a prolong bed rest due to abdominal problems.The patient also presented with moderate neck stiffness and reduced cervical rom.The back and neck oswestry score was 64/62 respectively and before treatment.On (b)(6) 2013 the patient presented with low back and pelvic pain (worsening pain onset 4 days prior).The patient described the pain as sharp, stabbing, and burning.The patient reported sleep disturbances difficulty with activities of daily living, and restricted sex life - secondary to pain.In a (b)(6) 2013 dated (b)(6) physicians progress report, it was noted that the patient had complaints of severe left low back pain with numbness, pins and needles into the left leg and foot.It was also reported that the patient had moderate-severe neck and left arm pain with frequent pins and needles sensation into the left arm.Treatments were listed as: chiropractic adjustments, physiotherapy, and home exercise.In a (b)(6) 2013 dated (b)(6) physicians progress report addendum to a (b)(6) 2013 report, it reported that the patient needed to see a chronic care specialist.In a (b)(6) 2013 dated (b)(6) physicians progress report, it was noted that the patient presented with an ¿acute/severe flare up¿ with great difficulty walking and severe low back pain.The patient was utilizing a crutch for ambulation and reported that they had been recently hospitalized for an unrelated injury but that at that time they noticed their low back had deteriorated severely.The patient felt their low back was unstable and that one of the screws had come loose.On (b)(6) 2013 it was recorded that the patient had the diagnosis of lumbar sprain post-surgery radiculitis, cervical and thoracic sprain.

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: 4242661
• MDR Text Key: 5062572
• Report Number: 1030489-2014-04323
• 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: 10/13/2014

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: 10/13/2014
• Initial Date FDA Received: 11/11/2014
• 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