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 Incontinence (1928); Pain (1994); Weakness (2145); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

It was reported that the patient underwent a fusion procedure from l4 to s1 using rhbmp-2/acs on (b)(6) 2011.Patient's post-operative period has been marked by increasingly severe pain and weakness in his low back and lower extremities.It was reported that the patient underwent a ct scan on (b)(6) 2013, revealing neurocompressive lesions at the implant site.Patient's condition necessitated revision surgery on (b)(6) 2013.It was reported that the patient continues to experience severe and unrelenting pain in his back and lower extremities.He suffers from incontinence, is unable to sit or stand for long periods, and his sleep is disturbed.It was reported that the patient is prevented from practicing and enjoying the activities of daily life he enjoyed pre-operatively, and he has otherwise suffered serious and permanent injuries.

Manufacturer Narrative

(b)(6).(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.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient presented with following pre-op diagnosis: 1.Low back and left leg syndrome, incapacitating.2.Lumbar spondylosis.3.Lumbar stenosis.4.Lumbar disc herniation (l4-l5) left side.5.Atherosclerotic cardiovascular disease, status posts multiple myocardial infarctions and stent placements.6.Non-insulin-dependent diabetes mellitus.7.Hypertension.8.Hyperlipidemia.9.Epilepsy.10.Depression/anxiety.11.Osteoarthritis.The patient underwent following procedures: 1.Gill procedure at l4.2.Semi-hemilaminectomy (inferior) at l3, bilateral.3.Foraminotomies, bilateral, at l3-l4 and l4-l5.4.Discectomy, left, l4-l5.5.Internal stabilization from l4 through s1, bilateral, using a pedicle screw and rod system.6.Lateral mass fusion from l4 through s1, bilateral using autogenous bone plus autologous bone plus bone morphogenic protein.7.Preparation of bone graft.8.Lntraop erative fluoroscopy.As per operative notes, "the bone graft prepared, as previously described, was placed along the lateral masses of the spine from l4 through s1 on both sides and packed within the remaining facet joint spaces.A large bone morphogenic protein was reconstituted and allowed to assimilate for more than 30 minutes.It was placed over the bone graft bilaterally from l4 through s1, taking care to make sure none entered the spinal canal at any time.¿ no intra-operative complications were reported.

• 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
• MDR Report Key: 3892522
• MDR Text Key: 4539430
• Report Number: 1030489-2014-02870
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 7510400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention