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 Device Operates Differently Than Expected (2913)

Patient Problems Loss of Range of Motion (2032); Weakness (2145); Burning Sensation (2146)

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.

Event Description

It was reported that (b)(6) 2008: the patient underwent mri of lumbar spine.Impression: l5-s1 fusion, degenerative disc disease at l4-5 more than l3-4, right paracentral l4-5 disc extrusion, and l3-4 broad based disc bulge more on the left.There is also evidence of right l4-5 foramen no stenosis.(b)(6) 2008: the patient underwent x- ray of chest 2 views std front+lat.Impression: negative chest.(b)(6) 2008: the patient presented with following preoperative diagnosis: recurrent right l4-5 radiculopathy status post two previous spine surgeries.Adjacent segment l4-5 spondylolisthesis and recurrent right-sided stenosis.The patient underwent the following procedures: exploration of previous l5-s1 fusion.Right l3 to l5 revision laminectomy.L4-5 transforaminal lumbar interbody fusion with peek cage.L4-5 posterolateral fusion.L4-5 instrumentation with pedicle screws and titanium rods from icon system.Right iliac crest aspirate.Local bone and bone morphogenic protein.Use of operating microscope.Per op note, a size cage from the blackstone set made of carbon peek was placed into the disk space after it had been packed with bmp and local bone.Twenty cc of iliac crest aspirate was taken from the right iliac crest via a jamshidi needle and this was mixed with local bone as well as bmp and graft-on matrix.This was all mixed and put into the posterolateral gutters.Most of the bmp was placed on the left side as the patient had an interbody on the right side with bmp at that level.No patient complications were reported.Intra-op portable cross table lumbar and c arm lumbar imaging were done.(b)(6) 2008: the patient was discharged.(b)(6) 2008: the patient underwent x ray of spine lumbar 3 views (std) ap+lat+lat-l5.Impression: documentation of l4-5 fusion (b)(6) 2009: the patient underwent x ray of spine lumbar 3v (std) ap+lat+lat-l5.(b)(6) 2009: the patient underwent x ray of lumbar spine which revealed l5 laminectomy, l5-s1 fusion, l4-5 posterior instrumentation, disc spacer and fusion.(b)(6) 2011: the patient underwent x ray of ribs unilateral 3 views with pa chest.The patient had fallen against cabinet hitting left rib area.Impression: question of summation artifact versus nondisplaced fracture along the anterolateral aspect of the left eighth rib.Question of left infrahilar infiltrate versus atelectasis.Impression: stable exam with no evidence of complication.Postsurgical changes l4 through s1.(b)(6) 2012: the patient presented with back pain at right sided lower back/buttock.The pain is dull/sharp, constant and has been getting worse.The pain increases with standing/walking, now with sitting too and improves with nothing specifically.The patient reports generalized weakness strength in les.The patient reports burning sensation in anterior aspect of the right thigh and chronic numbness in the right shin.Physical exam revealed range of motion of hips: limited internal rotation but painless bilateral.Palpation: some tenderness over the lumbosacral junction on the right side and trochanteric areas bilaterally.Sensation: impaired on the medial aspect of the right leg.

Manufacturer Narrative

(b)(4).

• 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: 5181979
• MDR Text Key: 29786918
• Report Number: 1030489-2015-02816
• 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: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Device Lot Number: M110706AE
• 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