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

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

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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.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 on (b)(6) 2011, patient underwent fusion surgery on the lumbar region from vertebrae l4-l5.Reportedly, the patient was implanted with rhbmp-2/acs in this surgery.Allegedly, " patient continues to suffer from chronic pain and is prevented from practicing and enjoying the activities of daily life that she enjoyed pre-operatively.".

Manufacturer Narrative

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.

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 on: (b)(6) 2012: the patient was pre-operatively diagnosed with l4-l5 pseudoarthrosis with retained hardware, degenerative disc disease, segmental lumbar instability and spinal stenosis and underwent the following procedures: 1) l4-l5 fusion exploration 2.L4-5 removal posterior segmental instrumentation 3.L4 revision laminectomy with decompression of cauda equina and spinal nerve roots.4.L5 laminectomy with decompression of cauda equina and spinal nerve roots.5.L4-l5 revision posterior spinal fusion.6.L4-l5 segmental instrumentation with pedicle screws.7.Use of local bone graft, cancellous allograft, and bmp.8.Insertion of indwelling opioid catheter for postop analgesia.9.Use of operating microscope.10.L4-l5 anterior lumbar diskectomy and interbody fusion.11.L4-l5 anterior lumbar machine allograft.12.L4-5 anterior segmental instrumentation.As per op-notes,¿ the level was confirmed using a lateral image with the spinal needle in place.The l4- l5 annulotomies carried out and a complete diskectomy and decompression from the anterior aspect of the disk space was performed.The peek interbody device was removed without difficulty.The patient had bmp used in the last surgery and there was some inadvertent extravasation of the disk space and this ectopic bone was removed through the anterior approach.The end plates were prepared as we proceed.A 13mm corticocancellous allograft was selected and a small central canal created.A half strip of bmp/acs was used to fill the space.A 41 mm lumbar plate from the synthes integra set was used and the lateral c-arm image reveals the appropriate length and it was then secured to the l4 and l5 bodies with four 6.5 x 20-mm corticocancellous locking screws.¿ the patient tolerated the procedure well without any intraoperative complications.

• 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: 6207962
• MDR Text Key: 63358602
• Report Number: 1030489-2016-03534
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/04/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: 12/05/2016; 06/04/2018
• Supplement Dates FDA Received: 09/27/2017; 07/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention