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 Muscle Weakness (1967); Burning Sensation (2146); Tingling (2171); Stenosis (2263); Discomfort (2330); Joint Swelling (2356)

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.

Event Description

It was reported that on (b)(6) 2009 patient presented with back pain.On (b)(6) 2009 patient presented with preoperative diagnosis of l5-s1 spondylolisthesis.Operative procedures: l5-s1 anterior lumbar discectomy.L5-s1 end plate preparatory with decompression of spinal canal.L5-s1 cage application x2.Anterior plating with pyramid titanium instrumentation l5-s1.Per-op notes: a 14 mm cage x 23 mm in length was selected.This was filled with bone morphogenic protein and actifuse.Actifuse was also placed into the posterior aspects of the disc space, and a dual canmila distractor device was applied.The end plates were reamed, followed by placement of the 2 cages side by side.Once these were in position, the dual distraction device was removed, and anterior plating was then carried out.The patient had extremely hard bone and was resistant initially to using it all and tapping.Ultimately, this was accomplished, and the medium-size plate was applied with 35 mm screw.The locking mechanism of the plate was then deployed, and confirmatory radiographs documented appropriate position of all implants.No patient complications.On (b)(6) 2009 patient discharged.On (b)(6) 2009 patient presented with complaint of back pain.Radiographs show excellent position of her instrumentation with progression of her fusion.On (b)(6) 2009 patient with back pain.On exam she has no neurologic deficits.On (b)(6) 2009 patient presented for visit with back discomfort.Radiographs show excellent position of her instrumentation with progression of her fusion.On (b)(6) 2010 patient presented for visit with back pain.On exam she is neurologically intact.Her wound is well healed.Radiographs show a solid arthrodesis at the l5-s 1 area.She has isthmic spondylosis which is likely responsible for the symptoms.On (b)(6) 2012 patient presented for preventive examination.Review of neuro/psychiatric systems: positive for insomnia.Review of musculoskeletal system: positive for: back pain, joint pain, joint swelling, and muscle weakness.On (b)(6) 2012 patient presented for bp check.On (b)(6) 2012, patient presented for office visit with following problems: lumbar radiculopathy, post laminectomy syndrome.Positive symptoms -worse with standing.Pain is described as tingling.Relieved by lying down.Relieved by medication.Worse with lifting.Pain is burning.Pain is described as numbness.Worse with sitting.Worse with walking.Shoulder symptoms right.Hand symptoms right.Hip symptoms.Foot symptoms.Back symptoms.Leg symptoms.Lower back pain.Review of neurological system: no dizziness, no vertigo, no fainting, no motor disturbances, and no sensory disturbances.Review of musculoskeletal system: general/bilateral:gait is normal.Review of psychiatric system: thought processes: an attention demonstrated no abnormalities.On (b)(6) 2012 patient underwent mri 3t lumbar spine wo.Impressions: postsurgical changes l5-s1 without evidence for complication.Mild neuro foraminal narrowing bilaterally l4-l5 secondary to facet arthropathy.Tarloy cysts bilaterally at s2 and s3 measuring between 8 and 10mm.On (b)(6) 2013 patient presented for office visit with following problems: lumbar radiculopathy, post laminectomy syndrome.Positive symptoms- worse with standing.Pain is described as tingling.Relieved by lying down.Relieved by medication.Worse with lifting.Pain is burning.Pain is described as numbness.Worse with sitting.Worse with walking.Shoulder symptoms right.Hand symptoms right.Hip symptoms.Foot symptoms.Back symptoms.Leg symptoms.Lower back pain.Review of neurological system: no dizziness, no vertigo, no fainting, no motor disturbances, and no sensory disturbances.Review of musculoskeletal system: general/bilateral: gait is normal.Review of psychiatric system: thought processes: an attention demonstrated no abnormalities.On (b)(6) 2013 patient presented with active complaints of lumbar radiculopathy, post laminectomy syndrome.Patient visited for spinal cord stimulator trial.Review of musculoskeletal system: cervical spine: general/bilateral: cervical spine had a normal appearance.Cervical spine showed no tenderness on palpation.Lumbar / lumbosacral spine: general/bilateral: lumbosacral spine exhibited no tenderness on palpation.Lumbosacral spine motion was normal.On (b)(6) 2013 patient presented for office visit with following problems: lumbar radiculopathy, post laminectomy syndrome.Positive symptoms - worse with standing.Pain is described as tingling.Relieved by lying down.Relieved by medication.Worse with lifting.Pain is burning.Pain is described as numbness.Worse with sitting.Worse with walking.Shoulder symptoms right.Hand symptoms right.Hip symptoms.Foot symptoms.Back symptoms.Leg symptoms.Lower back pain.Review of neurological system: no dizziness, no vertigo, no fainting, no motor disturbances, and no sensory disturbances.Review of musculoskeletal system: general/bilateral: gait is normal.Review of psychiatric system: thought processes: an attention demonstrated no abnormalities.On (b)(6) 2013 patient underwent mri-lumbar spine w/o contrast.Impression: at l5-s 1, bilateral pars defects, changes related to interbody fusion, mild left neural foraminal narrowing, 5 mm left foraminal disc protrusion with annular tear contacts exiting left l5 nerve root.Findings can be associated with left l5 radiculopathy, right paracentral posterior buckling of the l5 vertebral body cortex contacting descending right s1 nerve root.On (b)(6) 2013 patient underwent mri-thoracic spine w/o contrast.Impressions: c6-7 focal 2-3 mm central disc protrusion with a mild spinal canal stenosis.T3-4 mild right paracentral disc osteophyte with flattening of the right ventral thecal sac and cord.Ts-6 focal left paracentral and foraminal 2-3 mm disc protrusion with mild left inferior neural foraminal narrowing.T6-7 focal 2 mm left paracentral disc protrusion with flattening of the left ventral thecal sac and cord.Diffuse enlargement of the partially visualized thyroid gland.Recommend clinical correlation and further evaluation with thyroid ultrasound.On (b)(6) 2014 patient presented with following active problems: lumbago, lumbar radiculopathy, post lamin ectomy syndrome.Positive symptoms: relieved by relaxation.Worse with lifting.Worse with standing.Worse with walking.Pain is dull, aching.Worse with sitting.Pain is described as numbness.Pain is described as tingling.Relieved by lying down.Relieved by me dication.Leg symptoms right.Hip joint pain.Lower back pain.Shoulder joint pain right.Foot symptoms right.Review of neurological system: no dizziness, no vertigo, no fainting, no motor disturbances, and no sensory disturbances.Review of musculoskeletal system: general/bilateral: gait is normal.Review of psychiatric system: thought processes: an attention demonstrated no abnormalities.

• 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: 5095957
• MDR Text Key: 26566175
• Report Number: 1030489-2015-02469
• 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: 08/24/2015

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: 01/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110707AAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2008
• 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: 77