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 Ossification (1428); Chest Pain (1776); Contusion (1787); Dysphagia/ Odynophagia (1815); Bone Fracture(s) (1870); High Blood Pressure/ Hypertension (1908); Pain (1994); Stenosis (2263); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported that the patient underwent a cervical fusion procedure at c4 to c7 using rhbmp-2/acs on april 15, 2008.Patient's p ost-operative period has been marked by severe neck pain, difficulty swallowing, and difficulty breathing.On (b)(6) 2012, patient underwent a ct scan which revealed bony overgrowth compressing his cervical spine.Patient continues to suffer from severe neck and upper extremity pain accompanied by difficulty swallowing and breathing.

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.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on: (b)(6) 2008: the patient was pre-operatively diagnosed with herniated nucleus pulposus, c5-c6 with cervical spine spinal stenosis and disc bulge protrusion, c4-c5 and c6-c7.Asymptomatic disc bulge, c3-c4.Left arm pain and neck pain and underwent following procedures: anterior cervical de-compressive discectomy, c4-c5, c5-c6, c6-c7(three levels).Anterior cervical interbody fusions, c4-c5, c5-c6, c6-c7 (three levels).Placement of interbody fusion cages, c4-c5, c5-c6, c6-c7 (three levels).Use of bone morphogenic protein.Anterior spinal plate fixation, c4-c5, c5-c6, c6-c7 (four levels).As per op-notes ".A standard anterior approach to the cervical spine was undertaken by making a transverse oblique incision over the level of the c5-c6 disc.Further dissection was taken to expose the c4-c5, c5-c6 and c6-c7 discs by elevating the longus colli bilaterally.On the left hand side of c4-c5 there was found to be foraminal stenosis.Utilizing a high speed drill with a diamond blur, a foraminotomy was undertaken to relieve pressure on the exiting c5 nerve root.With this, there was found to be some protruding disc material in the foraminal region and this was removed with pituitary rongeurs.The exciting c5 nerve root was found to be fully decompressed.The end plates of c4 and c5 were then decorticated and the intervertebral disc space was trialed for a cage.A 6mm trial size was found to be the appropriate size, as such, a bone morphogenic protein was reconstituted and allowed to cure on collagen sponges for 15 minutes.One third of the sponge from bone morphogenic protein kit was placed inside the 6mm cage which was made of hydrosorb material.This cage was found to have excellent purchase between c4-c5 and thus completed the interbody fusion of c4-c5 as well as de-compressive discectomy.The same process was then carried out at c6-c7 followed by c5-c6 and 7mm cages were used at these two levels and 1/3 of a bone morphogenic protein soaked collagen sponge.Additionally at c6-c7 level there was found to be foraminal stenosis with a bulging annulus which was excised, opening the left c6-c7 neuroforamen.At the c5-c6 level three was actually found to be extruded nucleus pulosus material in the spinal canal in the left paracentral region and out into the left c6-c7 neuroforamen.This was completely removed with pituitary rongeurs as well as kerrison rongeurs.In doing so, the decompressed discectomies were completed both at c5-c6 and c6-c7 as well as the anterior cervical interbody fusions at c5-c6 and c6-c7.At this point the anterior spinal plate was placed utilizing at 67.5 mm plate.It was fixed to the anterior aspect of the cervical spine utilizing 13 mm screws in c4-c5, c5-c6 and c6-c7.A lateral radiograph showed the plate sand screws as well as interbody cages to be in good position, thus overall procedure was completed.The patient tolerated the procedure well.There were no complications¿.The patient underwent x-ray of cervical spine due to neck pain.Impression: anterior cervical fusion at c4 through c7 without malalignment of the cervical spine.On (b)(6) 2008: on a telephonic conversation, patient reported an increase in neck pain similar to pre-surgical pain.On (b)(6) 2008: the patient presented for follow up visit after anterior cervical disc fusion c4-c7.The patient was still having pain but pain is improving.On (b)(6) 2008: the patient presented for follow up on neck pain.The patient underwent x-ray anterior and posterior lateral flexion and extension lateral views of the cervical spine.Impression: well healing c3-c6 fusion.On (b)(6) 2008: the patient presented with neck pain.The patient also underwent x-ray of neck which showed that fusion of c4-c7 is well healed.On (b)(6) 2008: the patient presented with a chief complaint of occasional difficulties in swallowing.Impression: solid arthrodesis c4-c7.Continued minor dysphagia.On (b)(6) 2012: the patient presented for office visit for medications refilling.On (b)(6) 2012: the patient presented with chest pain and neck pain.Assessment: cervical fusion in 2008.Cervicalgia.Chest wall pain, contusion.Thoracic pain.Lumbago.Hypertension.Hypercholesterolemia.Gerd.On (b)(6) 2012: the patient underwent mri of chest without contrast due to chest pain.Impression: there is marked abnormal signal intensity in the sternum, low on t1 and bright on t2 weighting consistent with sternal fracture.Marked edema and fluid around that fractured sternum is noted.On (b)(6) 2012: the patient presented with a pain in a cervical area.The patient underwent mri of chest.Impression: cervicalgia.Myofascitis.Chest wall contusion.Sternal fracture.Thoracic strain.Lumbago.On (b)(6) 2012: the patient underwent ct of cervical spine.Impression: operative changes of anterior cervical discectomy and solid fusion c4-c5, c5-c6 and c6-c7.Degenerative disc changes, c3-c4 without definite cord compression.Bony stenosis of the neural foramina due to uncovertebral joint hypertrophy.Ap diameter of the thecal sac at c6-c7 is 10mm.Ap diameter of thecal sac at c5-c6 is approximately 12 mm.Ap diameter of the thecal sac at c4-c5 is approximately 12 mm.On (b)(6) 2012: the patient presented with a complaint of cervical pain with motion, thoracic pain with motion, no radiculopathy symptoms.On (b)(6) 2012: the patient presented with a chief complaint of difficulty in looking up and down, pain in chest and mid back.On (b)(6) 2012: the patient presented for office visit for cervical spondylosis, difficulty in lifting over head, difficulty in reaching sideways and underwent physical exercises and therapies.On (b)(6) 2012: the patient presented for therapy for neck pain.On (b)(6) 2013: the patient presented to office complaining of cervical and thoracic pain.The patient stated that he was unable to do the therapy.On (b)(6) 2013: the patient presented with pain in neck and diagnosed with moderate cervical spondylosis, causing occasional severe pain and underwent therapy.On (b)(6) 2013: the patient presented for therapy due to cervical pain.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 3895015
• MDR Text Key: 4673603
• Report Number: 1030489-2014-02909
• 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
• Report Date: 04/28/2016

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: 09/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110703AAG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2014
• Initial Date FDA Received: 06/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2008
• 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