MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC. BONE MORPHOGENETIC PROTEIN 2; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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

Patient Problems Rheumatoid Arthritis (1724); Connective Tissue Disease (1786); Lupus (1956); Pain (1994); Swelling (2091); Neck Pain (2433); Sleep Dysfunction (2517); Disc Impingement (2655); Test Result (2695)

Event Date 11/06/2009

Event Type  Injury  

Event Description

In 2009 i had a transforaminal interbody fusion with bone morphogenetic protein at l4-l5, l5-s1.I developed excessive swelling at the surgical site and increased leg pain.In 2011 i began experiencing rheumatoid symptoms resulting in widespread nerve and muscle pain.In 2014 - 15 my widespread muscle and nerve pain exacerbated, i began experiencing lumbar/sacral/coccyx/ left sided groin pain left leg radiculitis and neck pain.Eventually, mri/ct exams identified a displaced disc with surrounding bone at l4-l5.I had a discectomy on (b)(6) 2015.My orthopedic md reported he had to microscopically remove the bone growth; the growth was found to be indenting my l5 nerve root.Now in 2020, i continue to have debilitating (lumbar and cervical) spinal pain, arm pain, left leg radiculitis and left foot contractions.I can't sit or stand for more than 15-30 minutes.I must reposition myself every 15 minutes.I experience sleepless nights due to pain.I have trouble concentrating.My rheumatoid labs since 2011 have been interesting.Most recently, my rf was high.My rheumatoid diagnosis was lupus in 2011 and now has been changed to undifferentiated mixed connective tissue disease.I believe bmp is a bad product; it has caused me great bodily harm.It has disabled me.

• Brand Name: BONE MORPHOGENETIC PROTEIN 2
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 10069631
• MDR Text Key: 191556447
• Report Number: MW5094534
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 58 YR
• Patient Weight: 68