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

Catalog Number 7510800

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

Patient Problems Cyst(s) (1800); Weakness (2145); Stenosis (2263); Injury (2348); Osteolysis (2377)

Event Type  Injury  

Event Description

It was reported that on "(b)(6) 2008, patient underwent a posterior lumbar spinal fusion procedure at l3-4, l4-5, l5-s1 with a stryker cage.To achieve fusion, surgery was performed using rhbmp-2/acs at multiple vertebrae levels.Post operatively suffered 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 significant treatment to care for rhbmp-2/acs related injuries.Patient never recovered from the surgery involving 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)(4).

Event Description

It was reported that on: (b)(6) 2008: patient presented with following pre-op diagnosis: lumbar disk degenerative disease, degenerative slip and spinal stenosis l4-5.Patient underwent the following procedure: l3-s1 posterior decompression and fusion l5-s1 trans foraminal lumbar interbody fusion with peek three spacer, bmp-2 and local auto graft.Bilateral posterior iliac crest bone marrow aspirate, use of bone marrow aspirate concentrating system, l3-s1 spinal fusion with concentrated bone marrow aspirate and bmp-2 and local autograft.On (b)(6) 2009: patient presented for office visit with leg numbness and increased back pain.On (b)(6) 2009: patient underwent mri lumbar.Impression: post-operative granulation tissue and appears to produce severe bilateral neural foraminal narrowing.Post-surgical changes of posterior fusion from l3 through s1 and anterior fusion with discectomy at l5-s1 with interbody fusion device.Patient also underwent ct scan lumbar.Impression: postero-lateral instrumented fusion l3 through s1; anterior interbody fusion with interbody device at l5-s1.Lucency around left s1 transpedicular screw suggests loosening.Residual soft tissue within epidural space extending into foraminal and extra foraminal spaces bilaterally may reflect residual disc material and easy granulation material.This produces several bilateral neural foraminal narrowing.On (b)(6) 2009: patient presented for post-op follow up with significant low back pain and delayed onset of dorsiflexion weakness on right.Impression: segmentation anomaly.Lumbar spinal stenosis.Lumbar spondylosis.On (b)(6) 2009: patient presented for office visit with severe back and leg pain as a consequence of advanced degeneration of his lumbar spine and spinal stenosis.Patient has difficulty with weakness of right lower extremity.On (b)(6) 2009: patient underwent mri lumbar.Impression: at l5-s1, no significant central canal and stenosis.Persistent residual soft tissue density within the epidural space extending into foraminal and extraforaminal spaces bilaterally.This produces persistent severe bilateral neural foraminal narrowing.Lucency surrounding interbody fusion device as well as sclerosis at end plates with a subchondral cyst.Vacuum disc phenomenon at this level, all consists with loosening.On (b)(6) 2010: patient presented for post-op follow up visit.Patient's low back pain suddenly and severely became worse due to inflammatory effects of bmp which was added fusion material on both sides of length of fusion and into disk space at l5-s1.On (b)(6) 2010: patient underwent mri.Impression: bmp induced osteolysis had occurred around the tlif interbody implant at l5-s1, resulting in a loose implant which impede fusion, resulting in pseudoarthrosis at that level.

Manufacturer Narrative

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

• 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: 4623018
• MDR Text Key: 21178304
• Report Number: 1030489-2015-00608
• 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,Followup
• Report Date: 07/18/2016

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: 04/01/2011
• Device Catalogue Number: 7510800
• Device Lot Number: M110710AAE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2015
• Initial Date FDA Received: 03/23/2015
• Supplement Dates Manufacturer Received: Not provided; 07/18/2016
• Supplement Dates FDA Received: 07/27/2016; 09/24/2017
• Date Device Manufactured: 10/10/2008
• 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; Required Intervention