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

Catalog Number 7510600

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

Patient Problems Chest Pain (1776); Diarrhea (1811); Edema (1820); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Tingling (2171); Discomfort (2330); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2003 the patient underwent a spine fusion surgery on the lumbar region of his spine from l5 to s1 in which rhbmp-2/acs was used.It was reported that the patient's post-operative period has been marked by increasingly severe pain coupled with numbness in his low back with radiation into his lower extremities.Patient's injuries necessitated a revision surgery.It was reported that the patient continues to experience severe and unrelenting pain and numbness in his low back and lower extremities.He has difficulty sitting and standing for prolonged periods, and walking any distance.Reportedly, these injuries prevent the patient from practicing and enjoying the activities of daily life that he enjoyed pre-operatively, and he has otherwise suffered serious and permanent injuries.

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) 2003, the patient was presented for office visit with constant, unremitting low back pain radiating into the buttocks and into the thighs to the mid-thigh region bilaterally.The patient underwent mri scans of the lumbar spine which demonstrated a grade 1 spondylolisthesis at l5-s1.The disc appears to be highly degenerated and collapsed.Assessments: l5-s1 grade 1 spondylolisthesis with progressive low back pain radiating into the thighs over the past 8years despite extensive and comprehensive conservative care.On (b)(6) 2003, the patient underwent x-rays of the lumbar spine.Impressions: second degree spondylolisthesis at l5-s1 with degenerative disc disease at the l5-s1 level with a vacuum disc phenomenon present.Essentially stable lumbar spine with flexion and extension although there may be a 1mm difference with extension.On (b)(6) 2003, the patient underwent l5-s1 pedicle screw fixation using the percutaneous pedicle screw fixation system.Intraoperative fluoroscopic supervision and interpretation.Preoperative diagnosis: grade 2 l5-s1 spondylolisthesis.L5-s1 degenerative disc disease.Left knee pain/lumbago.Lumbar radiculopathy.Per-op notes: "the same procedure was followed at the s1 pedicle on the left.The pedicle screw extenders were then locked into position in the usual manner, and the arc attached.A separate stab wound superiorly was used to curve the arc towards the pedicle head of l5.The rod sizer was then used to determine that a 40mm rod was the right size.This was secured to the arc and passed through the heads of the pedicle using the system." on (b)(6) 2003, the patient underwent: l5-s1 anterior lumbar discectomy, distraction, decompression of the l5-s1 neural foramina, reduction of spondylolisthesis, interbody fusion l5-s1, application of interbody fusion cage/bone morphogenic protein.Preoperative diagnosis: l5-s1 spondylolisthesis, l5-s1 degenerative disc disease, low back pain/lumbago, lumbar radiculopathy.Per operative notes: "this point the disc space open and by distracting anteriorly, significant reduction of the spondylolisthesis was accomplished.With the drill tube in place the disc space was drilled in the usual manner under fluoroscopic guidance.The 18x23mm cages packed with bone morphogenic protein were then advanced down the fluoroscopic guidance.Ap, and lateral fluoroscopic images and visual inspection showed satisfactory positioning.After removing the drill tube and checking the cages laterally.On (b)(6) 2003, the patient was presented for office visit with some postoperative left buttock pain.He reported trouble sleeping and wanted to try something non-narcotic or habituating for sleep.The patient underwent x-rays of the lumbar spine.Finding: ap and lateral views of the lower back demonstrated grossly stable appearing bilateral screw and rod assemblies and metallic cages at the l5-s1 level with anterolisthesis at the same level.On (b)(6) 2003, the patient underwent ct scan of the lumbar spine.Impression: l5 spondylolysis status post 360 degree fusion with post-operative changes, but no clear cut focal disc protrusion.L3-4 mild circumferential annular bulging without focal disc protrusion.On (b)(6) 2003, the patient was presented for office visit with come burning pain in the left foot region.Assessments: suspect nerve root inflammation secondary to reduction.On (b)(6) 2003,the patient underwent x-rays of the lumbar spine.Impression: post-op changes.First degree l5-s1 spondylolisthesis.On (b)(6) 2004, the patient was presented for office visit with some occasional residual low back pain, but his legs feels fine and he is pleased with the outcome of the surgery.Assessments: given the weakness of the right triceps, had to rule out a right c7 radiculopathy.On (b)(6) 2004, the patient underwent mri of the cervical spine due to neck pain with right arm weakness.Conclusion: broad-based left sided disc protrusion at c3-4.This is a abutting the cord displacement and slight effacement.Small disc bulging at c4-5, c5-6 and c6-7.All of these indent the thecal sac without cord abutment.The c5-6 and c6-7 bulges are asymmetric and lateralize slightly more to the right.On (b)(6) 2005, the patient was presented for office visit with constant pain ion the right upper buttock region laterally, almost in the posterior auxiliary line.On exam, the patient was able to bend forward to touch his fingers to his toes and he could extend and laterally flex.On (b)(6) 2005, the patient underwent x-rays of the lumbar spine.Impressions: l5-s1 fusion.No complication evident.Minimal grade 1 anterolisthesis l5 on s1.On (b)(6) 2005, the patient was presented for office visit with status post two and half years of l5-s1 fusion.He reported tight tender area in the lower buttock region bilaterally.On (b)(6) 2006, the patient was presented for office visit with increasing pain in the right low back area, between the junction of the s uperomedialxxx iliac crest and the lumbar spine.On (b)(6) 2006, the patient was presented for office visit with chronic recurrent pain over the right inferior pedicle screw lead.Assessments: three year status post l5-s1 fusion with chronic recurrent tenderness over the screw head.On (b)(6) 2006, the patient underwent ct scan of the lumbar spine.Impressions: l5-s1 solid 360 degree fusion for an l5 spondylolysis.Mi nimal degenerative annular disc bulging at l2-3xxx, l3-4 and l4-5 without evidence of focal disc protrusion, central canal stenosis or significant neural foraminal narrowing.On (b)(6) 2006, the patient was presented for office visit with ct scan of the lumbar spine.Assessments: satisfactory fusion at l5-s1.Given that the fusion is solid, the pedicle screw fixation has become superfluous.The screws appear to be contributing to localized pain, based on the location of the pain, localized tenderness, and temporary relief with local injections.On (b)(6) 2006 ,the patient underwent removal of bilateral l5 and s1 pedicle screws and intervening rods, packing of pedicle screw holes with cortical cancellous bone.Preoperative diagnosis: status post l5-s1 fusion for treatment of l5-s1 spondylolisthesis.Successful l5-s1 fusion.Painful pedicle screws, complication of implanted orthopedic devices.Per-op notes: "the screw heads were identified and the set screws were removed.The rod was removed and then the pedicle screws.The pedicle screws holes were then repacked with cortical cancellous bone slivers, reconstituted in sterile saline.All four pedicle screws and the two rods were removed.On (b)(6) 2007, the patient was presented for office visit with chronic low back pain.Assessments: increasing low back pain approximately 3 years post l5-s1 fusion for the treatment of l5-s1 unstable spondylolisthesis.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2014: patient presented with complaint of lower extremity swelling.On (b)(6) 2012, (b)(6) 2013, (b)(6) 2014: patient presented with complaint of back spasms and reduced range of motion.Diagnosis: cervical segmental dysfunction or somatic dysfunction; thoracic segmental dysfunction; lumbosacral segment dysfunction; spasm of muscle.On (b)(6) 2014: patient presented with complaint of alcohol withdrawal, shakes.Assessment: alcohol withdrawal.Essential hypertension.History of pancreatitis.Hypokalemia.History of depression.Transaminase elevation.Long-term use of anticoagulants.History of splenoportal/splenic vein thrombosis.Questionable history of asthma.On (b)(6) 2014: patient presented with complaint of pancreatic getting bad.Impression: alcoholic liver disease.On (b)(6) 2014: patient presented with complaint of continuous sharp discomfort in the back of the right hip.Diagnosis: cervical segmental dysfunction or somatic dysfunct; thoracic segmental dysfunction; lumbosacral segment dysfunction; spasm of muscle.On (b)(6) 2014: patient underwent x-ray of chest due to chest pain.Impression: no radiographic evidence for acute cardiopulmonary process.Patient underwent esophagogastroduodenoscopy.Patient present for office visit and reported anemia and to rule out upper gi bleeding.On (b)(6) 2014: patient presented with complaint of lower extremity swelling.Impression: bilateral pedal edema secondary to hypoalbuminemia.Patient also underwent x-ray of chest.Impression: no acute cardiopulmonary process.On (b)(6) 2014: patient presented with complaint of alcohol withdrawal, shakes.On (b)(6) 2014: patient presented with complaint of vomiting and diarrhea.On (b)(6) 2014: patient presented with complaint of swelling in legs bilaterally, back pain.Assessment: hiccup; elevated glucose; edema; anemia.On (b)(6) 2015, (b)(6) 2014 patient presented with complaint of depression and suicidal thoughts.

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

On (b)(6) 2013, patient presented with complaint of back spasms and reduced range of motion.Diagnosis: cervical segmental dysfunction or somatic dysfunction; thoracic segmental dysfunction; lumbosacral segment dysfunction; spasm of muscle.On (b)(6) 2013: as per the billing records, the patient underwent ultrasound.On (b)(6) 2014, (b)(6) 2015: the patient presented for an office visit due to low back pain.On (b)(6) 2015, (b)(6) 2016: patient presented with complaints of continuous sharp, aching, tightness and tingling discomfort in the lower back.On (b)(6) 2015: patient presented with complaint of upper back pain tightness.On (b)(6) 2016: patient presented with complaint of intermittent aching discomfort in the back of the left hip.On (b)(6) 2016: patient presented with complaint of continuous aching and tightness discomfort in the back of the right hip.

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; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4180855
• MDR Text Key: 5162557
• Report Number: 1030489-2014-04064
• 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,consumer
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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 Weight: 82