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 Chest Pain (1776); Headache (1880); Neuropathy (1983); Pain (1994); Weakness (2145); Burning Sensation (2146); Dizziness (2194); Injury (2348); Joint Disorder (2373); Sore Throat (2396); Numbness (2415)

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.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 per medical records (b)(6) 2006 the patient presented with ddd, cervical radiculopathy and diskogenic pain.He underwent the following procedures: provocative cervical diskography at c6-7 and c3-4; direct fluoroscopy.Impression: positive provocative cervical diskography at c3-c4; negative provocative cervical diskography at c6-7.On (b)(6) 2006 the patient was admitted with cervical radiculopathy with neck pain.The patient underwent the following procedures: aspiration of autologous iliac crest; instillation with gardner - wells tongs; anterior cervical discectomy with microsurgical anterior diskectomy.Instrumentation, autograft fusion, at c3-4 with surgical microscope; anterior cervical discectomy, autograft insertion and fusion, c6-7 with surgical microscope and inoperative monitoring.Per op notes: the reaming depth was advanced to 16.Excess bone material was then mixed with the the bmp, which had been mixed with the patient's autologous bone marrow.The tapper was used, and following this, the 10-mm cage was countersunk in the disk space with radiographic control.Continuous monitoring was also undertaken.There were no changes appreciated.On (b)(6) 2007, the patient called complaining of dizziness.10 apr 2007 the patient complained of dizzy spells.On (b)(6) 2007 the patient presented with the complain of pain.On (b)(6) 2007 the patient presented to undergo colonoscopy with polypectomy.On (b)(6) 2007, (b)(6) 2008 the patient presented for an office visit.(b)(6) 2007 the patient underwent mri of c spine w/wo gadolinium and left shoulder.Impression: heterogeneous signal in supraspinatus tendon and small amount of fluid in subacromial/subdeltoid bursa.Question partial thickness tear or very small full thickness tear , but without retraction; relatively mild acromioclavicular joint degenerative change, but mildly impinging upon superior aspect of supraspinatus muscle and tendon; no other left shoulder abnormality seen.Impression(c-spine): prior fusion c3-4 and c6-7; no identifiable disc herniation or other significant central canal or foraminal impingement.On (b)(6) 2007 the patient presented to undergo left ac resection and rotator cuff repair.X-rays confirm left ac degenerative joint disease.Mri confirms left ac degenerative joint disease with impingement and a partial rotator cuff repair.On (b)(6) 2008 the patient presented for an office visit due to chest pain.On (b)(6) 2008 the patient presented for myocardial radionuclide imaging.Impression: no reversible defect identified; normal spect muga, with no wall motion abnormality identified; normal left ventricular ejection fraction of 59%.The patient also underwent stress test due to chest pain.Impression: uneventful adenosine infusion for chest pain or ekg changes; nuclear images are pending and will be reported separately.On (b)(6) 2008 the patient presented for an office visit.Clinical impression: lumbar and cervical failed and failed neck surgery syndrome.Chronic pain.On (b)(6) 2008 the patient called complaining of tooth infection.On (b)(6) 2008 the patient presented for an office visit.On (b)(6) 2008 the patient presented with classic c6 and c7 cervical radiculopathies of upper right extremity.He underwent the following procedure: anterior cervical microdiskectomy and autograft instrumentation and fusion c3-4, c6, c7 with surgical microscope.On (b)(6) 2009 the patient underwent an mri of the left knee due to knee pain.Impression: small knee joint effusion; abnormal bone marrow signal in medial femoral condyle.Question bone bruise vs reactive change; some cartilaginous injury and degenerative change with areas of erosion of cartilage at medial and lateral femoral condyles; well defined tear in posterior horn of medial meniscus.On (b)(6) 2009 the patient presented with neck pain and left upper extremity radiculopathy.He complained of extremity burning , numbness and weakness.The patient underwent mri cervical spine w/wo gadolinium.Impression: post surgical changes following c3-4 and c6-7 anterior instrumented fusions; no evidence of fracture or malalignment; bilateral foraminal narrowing at c5-6 and c6-7 secondary to uncovertebral osteophytes; no evidence of canal stenosis.On (b)(6) 2010 the patient's wife called complaining the patient is having severe headache.On (b)(6) 2010 the patient presented with shoulder pain and wanted lab tests to be done.On (b)(6) 2010 the patient presented with lab tests and diabetes.(b)(6) 2011 the patient presented with diabetes , sore throat and back pain.On (b)(6) 2011 the patient presented with diabetes , back pain and anxiety.On (b)(6) 2011 the patient called complaining of body aches with head and chest congestion.On (b)(6) 2012 the patient presented with diabetes , upper respiratory infection and shortness of breath.Review of systems: positive for - bone/joint symptoms, joint pain.On (b)(6) 2012 the patient called for refills.On (b)(6) 2012 the patient presented with diabetes and back pain.On (b)(6) 2012 the patient presented with fractured ribs and back pain.On (b)(6) 2012 the patient presented with the chief complaint of diabetes, sore throat , cough and shoulder physical.On (b)(6) 2012 the patient underwent x-ray of the chest.Impression: no acute pulmonary disease.On (b)(6) 2012 the patient presented with the chief complaint of cough and shortness of breath.On (b)(6) 2013 the patient presented with fatigue, back pain, diabetes mellitus.On (b)(6) 2013 the patient presented for an mri of cervical spine.Impression: mild left posterolateral disc protrusion/herniation and some marginal spurring at c5-6; status post anterior fusion c3-4 and c6-7; no other significant cervical spine abnormality seen, and no other significant change.On (b)(6) 2013 the patient presented with diabetes, back pain and right shoulder pain and hand shaking.On (b)(6) 2014 the patient underwent colonoscopy.On (b)(6) 2014 the patient called regarding his sore throat.

• 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: 5171001
• MDR Text Key: 29033688
• Report Number: 1030489-2015-02783
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• 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
• Date Manufacturer Received: 09/28/2015
• 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): Other
• Patient Weight: 104