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); Calcium Deposits/Calcification (1758); Pain (1994); Tingling (2171); Stenosis (2263); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient underwent an anterior lumbar spinal fusion procedure at l4-5 using rhbmp-2/acs and peek cage.Post- operatively the patient had significant pain in the area of the fusion surgery and extremities.It was also reported that the patient had significant damage to the spine.As a result of fusion surgery with rhbmp-2/acs, patient received medical treatment to care for rhbmp-2/acs related injuries.Patient never recovered from the surgery involving the use of rhbmp-2/acs, and continues to suffer from daily, disabling pain that prevents patient from performing many basic activities of daily living.

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.

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

Patient demographics: height: 6'1 it was reported that on: (b)(6) 2008: the patient underwent mri of lumbar spine without contrast.Impression: moderate degenerative facet changes at l4-l5 with the possibility of bilateral spondylolysis and very mild spondylolisthesis.Mild canal stenosis.Prominent disc protrusion of the right paramedian space that effaces the dural sac.Severe right neural foraminal narrowing with effacement of the exiting nerve root.On (b)(6) 2009: the patient was seen for evaluation of back pain and leg symptoms.On (b)(6) 2009: the patient was seen in office for pre-surgery education as he was scheduled for an l4-5 alif on (b)(6) 2009.The patient underwent exam of pa and lateral chest.Impression: no evidence of acute disease.On (b)(6) 2009: the patient presented and got admitted with complaint of back and bilateral radicular leg pain.With leg symptoms worse than his back pain.A review of his study revealed, the patient has degenerative changes at the l4-l5 level.He also has a grade 1 spondylolisthesis.Patient also has a posterior disk bulge significant bilaterally with stenosis.For which the patient underwent following procedures: anterior l4-l5 diskectomy, anterior l4-l5 bilateral neural foraminotomy, l4-l5 arthrodesis with bmp and bone graft, placement of interbody device using a synthes synfix cage and 20mm screws, use of intraoperative fluoroscopy for localization and placement of instrumentation, anterior lumbar interbody fusion, l4-l5.Per op notes, the synfix cage was packed with bmp and bone graft and placed in the disk space.Under fluoroscopic guidance, 4 screws were placed to secure the synfix cage.Next, bmp and master graft were placed anterior to the synfix cage.The patient tolerated the procedure well and no patient complications were noted.On (b)(6) 2009: the patient underwent x-ray of lumbar spine status post anterior lumbar fusion.Impression: post-surgical changes of an anterior fusion at the l4-l5 disc space level.On (b)(6) 2009: the patient got discharged with diagnoses: l4-l5 spondylolisthesis, grade 1, and herniated disk at l4-l5 with bilateral lumbar stenosis.On (b)(6) 2009: the patient presented with complaint of having some incisional pain.On (b)(6) 2010: the patient presented for neurology consultation due to bilateral spondylosis l4-l5 and severe right neural foraminal narrowing.On (b)(6) 2010: the patient underwent x-ray of lumbar spine while following up of fusion.Impression: interval decrease in l4-l5 disc space and progressive anterior calcification/ossification noted since (b)(6) 2009.Remainder of examination stable including anterolisthesis of l4 on l5 by 2mm.On (b)(6) 2010: the patient presented with complaint of tingling in his bilaterally legs, in posterior thighs and his calves.For which patient was told to undergo ct scan.On (b)(6) 2010: the patient underwent ct of lumbar spine without contrast, mri of lumbar spine with and without contrast due to back pain, bilaterally leg pain, lowers extremity numbness and tingling.Impression: spinal canal stenosis at l4 and l5.Severe bilateral neural foraminal narrowing at l4-l5.On (b)(6) 2010: the patient presented for an examination status post l4-5 anterior lumbar interbody fusion with complaint of development of bilateral leg pain that is worse with walking.

• 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: 4604670
• MDR Text Key: 18892267
• Report Number: 1030489-2015-00562
• 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
• Report Date: 08/03/2015

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: 06/01/2011
• Device Catalogue Number: 7510200
• Device Lot Number: M110803AAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/21/2009
• 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; Required Intervention