MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC PEEK INTERBODY CAGE RHBMP-2 AUTOGRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Device Problem Off-Label Use (1494)

Patient Problems Dysphagia/ Odynophagia (1815); Inflammation (1932); Nausea (1970); Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Date 04/18/2018

Event Type  Injury  

Event Description

I had acdf c5-c6 surgery on (b)(6) 2018 and my surgeon used medtronic rhbmp-2 graft; i believe it was off label but i'm not sure.I have the surgical report.I started having swallowing problems and severe pain right after which prompted me to make an appt to see him in (b)(6).He ordered imagining etc and concluded nothing was wrong.I kept returning with pain until it got so bad, i couldn't walk, swallow food, go to the bathroom and i ended up in the er this past (b)(6) because the bone graft and cage were grown into my spinal canal impinging on my spinal cord.The surgeon is dr (b)(6), he left me waiting 9 days in agonizing pain never bothered to even come and check on me while i was in the hospital.He blamed it on the hardware said maybe i was allergic and said he saw a lot of inflammation but my ct myelogram report said the bone graft and cage along with the screws were through the thecal sac and had made cord contact.He did a complete revision (b)(6) 2019 using the same bone graft, and i'm still in so much pain and nauseated everyday.I'm disabled now because of this.I wish i had known there was such terrible side effects to using medtronic rhbmp-2 graft; paralysis.Date the person first started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2019.Reason for use: herniated disc.

• Brand Name: MEDTRONIC PEEK INTERBODY CAGE RHBMP-2 AUTOGRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8699875
• MDR Text Key: 148173018
• Report Number: MW5087360
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 37 YR