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 Edema (1820); Muscle Spasm(s) (1966); Pain (1994); Sprain (2083); Stenosis (2263); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2007 the patient presented with the following preoperative diagnosis: lumbar spondylosis l4/5, back pain.The patient underwent the following procedures: right-sided transposes retroperitoneal approach for extreme lateral interbody fusion l4/5 using bmp and insertion of nuvasive 50 mm long 12 mm high lordotic cage.Application of staple to l4/5.Interpretation of c-arm.Neuroelectrophysiologic monitoring.Per op notes: the endplates were curetted and then a 50 mm long, 12 mm high lordotic peek cage filled with appropriate amount of bmp was tamped into the disc space under fluoroscopic guidance.The patient had x-rays done.On (b)(6) 2007 the patient underwent x-ray of the lumbar spine.Impression: fusion hardware l4-5 and l5-s1.On (b)(6) 2007 the patient had the mri of lumbar spine without contrast.Impression: interval fusion of l4-5.Annular bulge.Postoperative epidural fibrosis encasing the right s1 nerve.On (b)(6) 2009 the patient underwent mri of the cervical spine due to right sided neck pain.Impression: disc bulge with right paracentral herniation at the c5-c6 level, causing moderate right lateral recess narrowing.Musculoligamentous sprain/spasm.On (b)(6) 2011 the patient underwent mri of the lumbar spine.Impression: a diffuse bulge of the t11-12 intervertebral disc mildly indents the anterior aspect of the spinal cord, but no associated cord edema was seen.The bulging disc at the l1-2 level was not associated with neural compression.The bulging disc and mild apophyseal joint hypertrophy at the l2-3 level mildly narrow the spinal canal, particularly the left lateral recess, where there was perhaps mild compression of the descending left-sided l3 nerve roots, as suggested on image number 22 of sequence 19.Narrowing of the left l2-3 neural foramen probably does not result in neural compression.A diffuse bulge of the l3-4 intervertebral disc does not appear to be associated with neural compression.Status post l4-5 and l5-s1 interbody spinal fusion and status post right-sided laminectomy at the l5-s1 level.No neural compression at the l4-5 level.There was narrowing of the right l5-s1 neural foramen, perhaps by scar tissue, as well seen on image number 2 of sequence 15.This foraminal compromise might resulted in mild compression of the exiting right-sided l5 nerve roots within this foramen.On (b)(6) 2015 the patient underwent x-ray of the lumbar spine.A comparison was made with the mri dated (b)(6) 2014.Impression: discectomy and intervertebral basket placement at the l4-5 and l5/s1 levels identified.Spondylosis.Stable loss of height of t11.The patient also underwent ct of the lumbar spine without contrast due to bilateral leg and back pain.Impression: discectomy and bone graft placement with solid osseous fusion at l4/5 and l5/s1 levels.Laminectomy changes at l5/s1 level.No evidence of significant osseous canal or foraminal stenosis at these levels.Multilevel spondylosis causing mild spinal stenosis at the l2/l3 level.Foraminal stenosis.L1/2 and l2/3 vacuum phenomena.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on (b)(6) 2007, the patient was pre-operatively diagnosed with l5 radiculopathy, heterotopic bone-growth at previous foraminotomy site right l5-s1 and underwent repeat laminotomy, foraminotomy l5-s1, right surgery.

• 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
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5513585
• MDR Text Key: 40777786
• Report Number: 1030489-2016-00754
• 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,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2010
• Device Catalogue Number: 7510400
• Device Lot Number: M110609AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2007
• 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