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

Catalog Number 7510050

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

Patient Problems Syncope (1610); Apnea (1720); Chest Pain (1776); Dyspnea (1816); Edema (1820); Neuropathy (1983); Pain (1994); Stenosis (2263)

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.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) 2011, patient presented for neurology consultation for continued management of chronic kidney disease, stage 3.(b)(6) 2011, patient underwent following procedure: redo approach for anterior cervical decompression and discectomy (complete); arthrodesis, anterior cervical interbody techniques at c4-5; placement of interbody device at c4-5; placement of bmp at c4-5; for pre-op and post-op diagnosis of: cervical spondylosis c4-5.Intraoperative findings: once the anterior dissection was complete and an intraoperative x-ray was taken to confirm the level of interest, the operating microscope was brought to the operative field for magnification, improved illumination and microdissection technique using the high speed drill, spinal curettes, 1 and 2mm kerrison ronguers as well as sharp dissection with dissection with a 15 blade scalpel.This patient had severe degenerative disc disease at c4-5 and severe neuroforaminal stenosis.This procedure required considerably more time and tedious effort owing to the significant fibrosis in the middle facial plane of the neck.This required sharp adhesolysis for mobilization of the carotid artery, trachea and esophagus.The dissection required considerable more time and tedious effort than usual owing to the dense fibrosis.The anterior cervical plate was also identified, but it was not removed.As per op notes: ".A pre-operative x-ray was taken to determine the level of the skin incision and this was marked on the skin accordingly.With entire disc removed a high speed drill was used to partially decorticated the adjacent endplates, leaving a alight posterior ledge on the superior enplate and anterior ledge on the inferior endplate.The intervening space was measured with a trial and it was then custom fitted with a prevail interbody implant after the central portion of it was filled with a small pledget of the absorbable sponge soaked in bmp.The patient seemed to rest comfortably." (b)(6) 2011: patient underwent thoracic lumbar myelogram and post myelogram ct scan; for pre-op and post-op diagnosis of: thoracic and lumbar radicular pain.No complications were reported.(b)(6) 2011: patient presented for office visit for chronic back pain and bilateral thigh pain; and possible need for intrathecal drug delivery catheter revision.(b)(6) 2011: patient presented with complaint of: chronic back pain and bilateral thigh pain.Possible need for intrathecal drug delivery catheter revision.Diagnostic impression: intrathecal drug delivery occlusion; chronic pain syndrome; neuropathy; renal insufficiency.(b)(6) 2012: patient underwent following procedure: exploration of pain pump catheter and revision; for pre-op and post-op diagnosis of: chronic pain syndrome; occlusion of the intrathecal catheter.No complications were reported.(b)(6) 2012: patient presented with complaint of left shoulder pain having difficulty with any rotation and overhead activities.Impression: left shoulder impingement.Rotator cuff tendinopathy with possible tears.Possible labral tear.(b)(6) 2012: patient presented with pre-op diagnosis as left shoulder rotator cuff tear versus tendinopathy, possible biceps tear and subacromial impingement.For which, patient underwent following procedures: left shoulder arthroscopy.Arthroscopic rotator cuff repair.Arthroscopic labral repair.Biceps tenotomy.Subacromial decompression.Patient tolerated the procedure well without any intraoperative complications.(b)(6) 2012: patient presented for re-evaluation of his chronic axial spine pain with radiating pain in both extremities.Impression: chronic pain syndrome; stenosis, cervical; spondylosis, cervical without myelopathy; back pain, thoracic region.(b)(6) 2012: patient presented with pre-op diagnosis: intrathecal pump malfunction.For which patient underwent replacement of tubing from pain pump to subarachnoid space requiring a small thoracic laminectomy.Patient tolerated the procedure well without any intraoperative complications.(b)(6) 2012: patient presented with pre-op diagnosis as: left shoulder persistent pain with possible rotator cuff tear.For which, patient underwent following procedures: left shoulder arthroscopy.Arthroscopic rotator cuff repair including the subscapularis tendon and also rotator cuff repair including supraspinatus tendon and debridement of labral tear and subacromial bursectomy and debridement.Patient tolerated the procedure well without any intraoperative complications.(b)(6) 2012: patient presented for office visit due to syncope, chest pain and shortness of breath.(b)(6) 2012, patient presented for pre-operative cardiopulmonary risk stratification.(b)(6) 2012, patient underwent following procedure: left shoulder arthroscopy; arthroscopic rotator cuff repair of the subscapularis tendon; arthroscopic rotator cuff repair of the partial bursal-sided rotator cuff tear; debridement of degenerative labral tear.Indications: persistent pain after fall following previous left shoulder repair.(b)(6) 2014, patient presented with complaint of shortness of breath.(b)(6) 2014, patient presented with cough and chest pain for 2-3 days.(b)(6) 2014: patient underwent ct of chest without contrast.Impression: 5.8 x4.9 cm mass-like density in the posterior right lung.Findings are consistent with neoplasm.Dense consolidation cannot be completely excluded.Recommend pet ct.Mediastinal adenopathy.Again recommend pet ct.(b)(6) 2014: patient presented in ed with complaint of chest pain.(b)(6) 2014, patient presented for office visit for follow-up on edema which began five years ago.(b)(6) 2014, patient underwent sleep study.Impression: the polysomnographic data is consistent with severe obstructive sleep apnea.(b)(6) 2014, patient underwent sleep study.Impression: obstructive sleep apnea.(b)(6) 2015: patient underwent ct myelogram of cervical spine due to cervicalgia.Impression: evidence of prior anterior cervical fusion, without ct evidence of complication.Interval healing of the previously noted spinal fractures.Multilevel degenerative changes, without spinal stenosis or neural foraminal narrowing.At least moderate underlying centrilobular emphysema.Patient underwent cervical, thoracic and lumbar conventional myelogram due to cervicalgia, back pain and lumbago.Impression: no radiographic evidence of complication involving the cervical and thoracolumbar surgical hardware.No evidence of spinal stenosis.

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 USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5793167
• MDR Text Key: 49491788
• Report Number: 1030489-2016-02062
• 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,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2012
• Device Catalogue Number: 7510050
• Device Lot Number: M111055AAB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2010
• 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: 83