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

Catalog Number 7510400

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

Patient Problems Muscle Spasm(s) (1966); Neuropathy (1983); 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) 2013, the patient presented with the following preoperative diagnoses: 1.Cervical spondylotic myelopathy with stenosis c5-c6, c6-c7 with multilevel neural foraminal stenosis and cord compression due to disk osteophyte complexes.2.Spondylolisthesis c4 -c5.3.Abnormal posture of cervical spine with mild rotation to the right and left lateral bending.4.Bifid anterior and posterior arch of c1 which appears congenital.5.Basilar impression of odontoid onto clivus with settling, but does not appear to have navigation into the foramen.6.Severe neck pain and severe spasm.7.Left c5-c6 radiculopathy on eng.8.Degenerative disk disease, facet arthropathy, multileve1 occipita cervical spine.9.Adhesive capsulitis partial left shoulder.10.Patient with a history of lupus, multiple courses of steroids in the past, and multiple sclerosis.11.History of prior lumbar surgery x4 from 1985 to 1987 with steffee rods.12.Patient with a history of blackouts x3 that has been worked up.13.Patient with a history of left eye blurriness and left-sided jaw symptoms that go to her shoulder area.14.Radiculopathy and paresthesias left upper extremity more significant and only mild on the right upper extremity.15.Weakness of bilateral intrinsic 4/5, finger flexors 4/5, wrist dorsiflexors 4+/5 with shaking upon motor stressing on the upper extremities.16.Dysphagia x2 months with a negative esophagram.17.Ataxia and loss of dexterity of the upper extremities.The following procedures were performed: 1.Partial corpetomy inferior c5.2.Anterior cervical diskectomy, fusion c4-c5, c5-c6, c6-c7.3.Bilateral neural foraminotomies c5-c6, quite extensive and also extensive left c6-c7 neural foraminotomy.4.Anterior cervical plating/ instrumentation c4-c7 with max-an plate form biomet, 42 mm in length.5.Peek cage/mechanical spacer at c4-c5, c5-c6, c6-c7.6.Anterior cervical fusion performed with local autograft bone mixed with bone graft demineralized bone matrix.Complications: none.Per op notes: diskectomies were performed using a sharp knife as well as pituitary rongeurs and curets.The patient then had neural foraminotomies bilaterally c5-c6 left extensively and also extensive left c6-c7.The patient then had epidural bleeding controlled with floseal.The patient then had attention paid on placement, after decompression, of a peek cag e/mechanical spacer at c4-c5 (6mm) and also at c5-c6 (8mm) and c6-c7 (7mm).The patient then had placement of anterior cervical titanium plate from c4, c5, c6, c7 with screws on the right c4, c5, c6, c7 (4.0 x 14 mm), on the left c4, c5, and c7 (4.0 x 14 mm).The plate was 42 mm in length, max-an plate.(b)(6) 2013 the patient presented with severe neck pain and suboccipital pain with headaches and was diagnosed with the following preoperative diagnoses: 1.Basilar impression/settling / invagination right at the tip of the foramen magnum with odontoid onto the clivus /tip of the foramen magnum.2.Divot component of c1 anterior and posterior which appears congenital.3.Patient is status post partial corpectomy inferior c5, anterior cervical discectomy, fusion and plating c4 through c7 on (b)(6) 2013.4.Severe neck pain, left shoulder pain with radiculopathy and left c5-6 radiculopathy on emg.7.Left shoulder partial adhesive capsulitis with degenerative changes.8.Cervical spondylotic myelopathy with multilevel neuroforaminal stenosis.9.History of blackouts, left sided jaw pain, left eye blurriness which has been worked up in the past.10.Dysphagia.11.Ataxia and loss of dexterity, stable with some mild improvement after the anterior cervical surgery.12.History of lupus, multiple courses of steroids and multiple sclerosis.13.Partial adhesive capsulitis, left shoulder as well as left shoulder tendinitis.14.History of 4 lumbar surgeries (1985-1987) with steffee rods.15.Mild weakness of the left upper extremity 4/5 which appears to be improving.16.Patient has a left c3 lateral mass defect on ct scan.17.Left upper neck pain and radiculopathy in the c4-c5 distribution clinically.Procedures performed: 1.Neural foraminotomy, left c3-c4, c4-c5.2.Occipital c2 fusion.3.C2-c3 posterior fusion.4.Posterior cervical fusion, c2-c3, c3-c4, c4-c5, c5-c6, c6-c7.5.Posterior cervical instrumentation from occiput through c6 with the globus ellipse system.6.Posterior cervical fusion performed with local autograft bone, mixed with demineralized bone matrix and allograft croutons as well as rhbmp-2/acs.7.Three pronged tong application removal.Per op notes: attention was placed on through the decortication of the facet joints and posterior elements from occiput including the occiput c, c2, c3, c4, c5, c6 and c7.A fusion was performed of the lateral masses and posterolateral elements of occiput c1, c2, c3, c4, c5, c6 and c7 with local autograft bone mixed with demineralized bone matrix and allograft croutons as well as rhbmp-2/acs.Attention was then place on contouring bilateral rods from occiput ot the c6 posterior instrumentation.No complications were reported.(b)(6) 2014 the patient presented with the following pre-op diagnoses: 1.Painful retained hardware occiput to c6 with good interval healing of the fusion based on imaging.2.Spasm, right sided more than left , of the posterior cervical paraspinous and trapezial area.3.Facet arthropathy posterior c7-t1, t1-t2 area.4.Status post left neural foraminotomies c3-c4 , c4-c5 and occipital c6 posterior fusionand instrumentation as well as in situ fusion to the c7 level.5.Status post partial corpectomy inferior c5, anterior cervical discectomy, fusion and plating c4 through c7.6.Basilar impression/settling/invagination right at the tip of the foramen magnum.7.Bifid component of c1 anterior and posterior which appears congenital.8.Left shoulder partial adhesive capsulitis with degenerative changes , left shoulder tendinitis.9.Facet arthropathy cervicothoracic junction.10.Degenerative disk disease cervicothoracic spine.11.Cervical spondylotic myelopathy with multilevel stenosis.12.History of blackouts.13.Left eye blurriness.14.Left sided jaw pain, improved after posterior occipital cervical surgery.15.Dysphagia.Negative esophagram.16.Ataxia, loss of dexterity, stable.17.History of lupus and multiple courses of steroids.18.Multiple sclerosis.19.Patient with history of lumbar surgeries through 1985-1987 with steffee rods.20.Weakness left upper extremity, 4+/5, improving.21.Disk osteophyte complex, left paracentral disk at t7-t8 with left sided ventral lateral thecal sac encroachment, some mild spinal cord compression.22.Left scapulothoracic dysfunction.23.Left sided pectoral pacemaker in place.Procedures performed: posterior hardware removal occipitocervical to c6 level globus system.2.Fusion exploration occipitocervical spine with good clinical healing.3.Three prong tongs application removal.4.Fluoroscopic interpretation in ap, lateral and oblique planes of less than an hour.Per op notes: the patient had the hardware exposed, including c3 through c6 screws bilaterally as well as occipitocervical plate.All the hardware has removed.All the screws removed.The rods were removed.The occipital plate was also removed.The patient then had attention placed on the fusion exploration which showed no gross motion of the occipitocervical spine clinically.

• 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: 5349475
• MDR Text Key: 35210074
• Report Number: 1030489-2016-00053
• 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: 12/14/2015

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: 08/01/2015
• Device Catalogue Number: 7510400
• Device Lot Number: M111201AAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2015
• Initial Date FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/15/2013
• 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