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

Catalog Number 7510800

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

Patient Problems Loss of Range of Motion (2032); Tingling (2171); Neck Pain (2433); Disc Impingement (2655)

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.

Event Description

It was reported that on (b)(6) 2009 the patient presented for office visit due to sleep apnea.(b)(6) the patient presented for an office visit due to chronic back pain.(b)(6) 2009 the patient presented for an office visit due to abdominal pain.(b)(6) 2009 the patient presented for an office visit due to (b)(6).(b)(6) 2009 the patient presented for an office visit due to shortness of breathing.(b)(6) 2010 the patient presented for follow up of obstructive sleep apnea.Final diagnoses: obstructive sleep apnea, currently well treated on auto positive airway pressure at a pressure of 4 to 18.Sinus pain.Obesity.Chronic pain due to herniated disks sustained during injury.Intentional weight loss.(b)(6) 2010 the patient presented for office visit due to myalgia, aheum.(b)(6) 2010 the patient underwent the x-ray of chest.Impression: no acute infiltrates.Linear 1.3 cm density left lung base consistent with probable scar.Peribronchial thickening.The patient underwent the x-ray of lumbar spine.Findings: the first image demonstrated instrument localization at s 1-l2.The second image demonstrated instrument localization from l3 lo s1.The third image demonstrated pedicle screws l4, l5 and s1 with intervening interbody disc spacers.(b)(6) 2010 the patient presented for bir shot.(b)(6) 2010 the patient presented for an office visit due to sleep disturbances.The patient chest x-rays showed normal heart size, normal pulmonary vasculature, clear lung fields.Final diagnoses: chronic tobacco abuse.Obstructive sleep apnea syndrome on autopap.Obesity.History of lyme's disease.(b)(6) 2010 the patient underwent radiology chest pa <(>&<)> lt.Lat.(b)(6) 2010 the patient presented for office visit due to lumbar disc fusion.(b)(6) 2010 the patient was admitted to hospital due to low back pain with bilateral lumbosacral radiculopathy, central herniated nucleus pulposus and painful lumbar discogenic syndrome, l4-5 and l5-s1.(b)(6) 2010 the patient underwent the posterior lumbar interbody fusion and instrumented transverse process arthrodesis, l4-5, l5-s1.Operative procedure: l4, l5 and s1 laminectomy, bilateral l4-5 and bilateral l5-51 diskectomy and posterior lumbar interbody arthrodesis with implantation peek interbody prosthetics.L4 through s1 segmental instrumentation with pedicular screw fixation.L4 through s1 posterolateral arthrodesis.Image-guided computer-assisted stereotactic navigation to assist in instrumentation placement.Posterior single incision 360 degree lumbosacral instrumented arthrodesis.Utilization of bone morphogenetic protein in conjunction with local bone for both interbody arthrodesis and posterolateral arthrodesis.Per op notes: the transverse processes of l4 and l5 and sacral ala were bilaterally decorticated with legend drill with bur attachment.The posterolateral beds were then bilaterally packed with local bone, bone graft and absorbable sponges impregnated with bone morphogenetic protein, thereby allowing for bilateral posterolateral arthrodesis.(b)(6) 2010 the patient underwent the physical therapy due to low back incision pain.(b)(6) 2010 the patient had neurological symptoms of numbness, weakness and tingling.(b)(6) 2010 the patient had musculoskeletal symptoms of joint stiffness.(b)(6) 2010 the patient discharged with the following diagnosis.Low back pain with bilateral lumbosacral radiculopathy, central herniated nucleus pulposus, and lumbar discogenic syndrome, l4-5, l5-s 1.(b)(6) 2010 the patient presented for follow up of l4 through s1 decompression and reconstruction.(b)(6) 2010 the patient presented for follow up of his lumbar spine fusion.(b)(6) 2010 the patient presented for follow up of his back surgery on (b)(6) 2010.Patient complained of back and leg pain.(b)(6) 2010 the patient presented for follow up of l4 through s1 decompression and reconstruction.X-rays revealed satisfactory prosthetic position, instrumentation position and spinal alignment.(b)(6) 2010 the patient presented for follow up of lumbar spine fusion.(b)(6) 2010 the patient presented for office visit due to back pain.Patient presented for x-ray of l/l spine.(b)(6) 2010 the patient presented for bir shot.(b)(6) 2010 the patient presented for an office visit for pain management.(b)(6) 2010 the patient presented for an office visit due to low back pain with lower extremity radicular pain.X-rays of the lumbar spine revealed satisfactory prosthetic position, instrumentation position and spinal alignment.The patient underwent x-rays of lumbar spine.Impression: there were no fractures or dislocations of the lumbar spine.Postoperative changes.(b)(6) 2010 the patient was referred to other hospital for continuation of current pain medications.Impression: post lumbar laminectomy/fusion syndrome.Displacement of lumbar discs.Lumbar radiculopathy, clinical.Chronic pain syndrome due to trauma and post op.Cervicalgia.Myofascial pain syndrome.(b)(6) 2010 the patient presented for an office visit for psychological services.(b)(6) 2010 the patient was presented for neurosurgical reevaluation.Cervicalgia with cervical radiculopathy, bulging disc annulus cs-6.Low back pain with lumbosacral radiculopathy l4-5 and l5-s1, herniated nucleus pulposus and painful lumbar discogenic syndrome.(b)(6) 2010 the patient presented for an office visit due to low back pain with bilateral posterior radicular pain to the malleolar region.X-rays revealed satisfactory prosthetic position, instrumentation position and spinal alignment.Lumbar examination revealed a well-healed incision.(b)(6) 2010 the patient presented with low back pain, posterior leg numbness, neck pain, radicular pain, hand n/t, limited rom, weakness, unable to work, and restricted functional adl (b)(6) 2010 the patient presented for reevaluation.Patient reported improved functional status with physical therapy intervention.(b)(6) 2010 the patient presented for an office visit with low back pain with left posterior radicular pain to the foot.Neurological testing revealed no focal motor or sensory deficit.(b)(6) 2010 the patient underwent detoxification.(b)(6) 2010 the patient presented for an office visit with low back pain with bilateral lower extremity radicular pain.X-rays reveal satisfactory prosthetic position, instrumentation position and spinal alignment with tall disc space height at the l3-4 level.(b)(6) 2010 the patient presented for an office visit due to chronic back pain, disc herniation.(b)(6) 2011 the patient presented for bir shot.(b)(6) 2011 the patient presented for pain management.(b)(6) 2011 the patient presented for an office visit due to chronic left shoulder pain.(b)(6) 2011 the patient underwent mri of left shoulder.Impression: probable tiny anterior leading image perforation of the supraspinatus tendon insertion.(b)(6) 2011 the patient presented with cervical radiculopathy.Patient presented for bir shot.(b)(6) 2011 the patient presented with right leg pain.(b)(6) 2011 the patient presented for an office visit due to chronic back pain, disc herniation.(b)(6) 2011 the patient presented for bir shot.(b)(6) 2011 the patient presented for an office visit due to chronic shoulder pain.(b)(6) 2012 the patient presented with coronary artery disease.Impression: myocardial perfusion imaging was normal.Overall left ventricular systolic function was normal without regional wall motion abnormalities.Left ventricular ejection fraction was 80%.The patient underwent 20 echo <(>&<)> doppler study.Impression; this was a technically adequate study.The left ventricular systolic function was normal.Left ventricular ejection fraction was 65%.Normal wall motion of all segment's (b)(6) 2012 the patient admitted to health care program.(b)(6) 2012 the patient underwent doppler venous low ext unilat right.Impression: no evidence of deep venous thrombosis.(b)(6) 2012 the patient presented for office visit.(b)(6) 2012 the patient presented for an office visit (b)(6) 2012 the patient presented for office visit due to pain in shoulder, neck and back.(b)(6) 2013 the patient presented for office visit due to impingement and adhesive capsulitis.(b)(6) 2013 the patient underwent x-rays of chest.Impression no active consolidative infiltrates.Linear scarring or atelectasis at the left base.Bilateral pleural thickening.(b)(6) 2013 the patient presented for office visit due to fever chill.(b)(6) 2013 the patient admitted to hospital due to chronic impingement of the left shoulder.The patient underwent the diagnostic arthroscopy, followed by arthroscopically assisted subacromial decompression.The patient underwent radiological test of chest.Impression: no active consolidative infiltrates.Linear scarring or atelectasis al the left base.Bilateral pleural thickening.(b)(6) 2013 the patient presented for follow up due to left shoulder with subacromial decompression.(b)(6) 2013 the patient presented for office visit due back and leg pain.(b)(6) 2013 the patient presented for an office visit due to depression.(b)(6) 2014 the patient presented for office visit due to cough.(b)(6) 2014 the patient presented for office visit due to diabetes.

• 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: 5094922
• MDR Text Key: 26488440
• Report Number: 1030489-2015-02464
• 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: 05/01/2012
• Device Catalogue Number: 7510800
• Device Lot Number: M110811AAB
• 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: 01/11/2010
• 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: 129