MAUDE Adverse Event Report: BONE MORPHOGENETIC PROTEIN (BMP); FILTER, RECONBINANT HUMAN BONE MORPHOGENETIC PROTEN CALLAGEN SCAFFOLD W/METAL PR

Device Problem Off-Label Use (1494)

Patient Problems Dysphagia/ Odynophagia (1815); Respiratory Distress (2045); No Code Available (3191)

Event Date 09/18/2008

Event Type  Injury  

Event Description

I had an adverse reaction to the bmp used during my 2008 cervical disc fusion.The off label dose of bmp caused swallowing problems, breathing problems and lumbar spine tumors first appeared on mri 2013 (b)(6).I need the fda to investigate on my behalf.Dr (b)(6) knowingly used a product that was not fda approved.Dr (b)(6) lied to me about the safety of this chemical that he allowed to enter my spinal fluid where he tore a hole in my spinal cord at c7.Dr (b)(6) tried to cover his mistakes up from the first surgery, he botched and made my spinal and other health substantially worse.I can never be made whole again.He jeopardized my life and must be held accountable.Please help me.I need this confirmed once and for all.He never bothered to say he was sorry.Was this device serviced by a third party servicer? yes.Fda safety report id# (b)(4).

• Brand Name: BONE MORPHOGENETIC PROTEIN (BMP)
• Type of Device: FILTER, RECONBINANT HUMAN BONE MORPHOGENETIC PROTEN CALLAGEN SCAFFOLD W/METAL PR
• MDR Report Key: 8555752
• MDR Text Key: 143460730
• Report Number: MW5086220
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• 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: 04/24/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 58 YR
• Patient Weight: 94