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 Dysphagia/ Odynophagia (1815); Dyspnea (1816); Neuropathy (1983); Pain (1994); Dysphasia (2195); Neck Pain (2433)

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.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.

Event Description

It was reported that on (b)(6) 2007, the patient underwent anterior cervical diskectomy and fusion surgery from vertebrae c5 to c6.Reportedly, rhbmp-2/acs was used in this surgery.Post-op, the patient suffered from increasing severe neck pain and radiculopathy.Patient continued to experience extreme neck pain, pain radiating to the back of his head, down to his shoulders and into his left arm, and jerking and twitching in his left arm and fingers.He also experienced difficulty breathing, swallowing, and speaking, bladder and bowel issues, and must sleep in a recliner.These serious injuries prevent patient from practicing and enjoying the activities of daily life.

Manufacturer Narrative

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

The patient presented with the following pre-op diagnosis: 1) c5-6 cervical spondylosis, 2) disk herniation.He underwent the following procedures: 1) anterior cervical microdiskectomy, c5-6.2) bilateral foraminotomy and anterior interbody arthrodesis, c5-6.As per the operative notes, distraction pins were placed in c5 and c6.One millimeter of in line distraction was obtained.An annulotomy in the disk was obtained with an 11 blade.The anterior third of the disk was removed with pituitary rongeurs.The operating microscope was brought into the field under 5 power magnification, the anspach dissector was used to remove disk and cartilaginous end plate back to the posterior longitudinal ligament.A combination of soft tissue disk protrusion and cartilaginous material was occluding the foramen on the right side.The posterior longitudinal ligament was taken down and wide bilateral foraminotomies were accomplished.The spinal cord and nerves were completely decompressed.Trial spacers were introduced and a 7 mm machine structural cortical cancellous allograft was selected.The core of the allograft was drilled.A small piece of bone morphogenic protein was placed within the allograft and it was gently impacted into place under direct visualization.The construct was secured in place with a 22 mm titanium anterior cervical plate and four 14 mm self-drilling screws.The patient tolerated the surgery well.

• 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: 5767781
• MDR Text Key: 48711474
• Report Number: 1030489-2016-01946
• 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: 10/31/2018

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
• Device Expiration Date: 03/01/2010
• Device Catalogue Number: 7510200
• Device Lot Number: M110701AAG
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2016
• Initial Date FDA Received: 07/04/2016
• Supplement Dates Manufacturer Received: 06/08/2016; 10/02/2018
• Supplement Dates FDA Received: 09/23/2017; 10/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other