MAUDE Adverse Event Report: NUVASIVE, INC. SIMPLIFY CERVICAL ARTIFICIAL DISC; PROSTHESIS, INTERVERTEBRAL DISC

Patient Problems Erosion (1750); Failure of Implant (1924); Scar Tissue (2060); Osteomyelitis (4533); Implant Pain (4561)

Event Date 07/20/2022

Event Type  Injury  

Event Description

I had a nuvasive simplify disc implant placed in the c5-c6 region of my cervical spine to replace a mildly herniated disc.This is a relatively new implant that received fda approval in late 2020.This surgery was performed by dr.(b)(6) in (b)(6) 2022 at an outpatient surgery center owned by his practice.After complaining about continuing pain in the area for months and several additional visits to the same surgeon to evaluate the position and appearance of the implant i was repeatedly told everything looked fine.However, by (b)(6) 2023 the pain was so great that i was seeking additional treatment via a different doctor and additional imaging showed that the area was very likely infected (osteomyelitis) with no apparent attachment of the device.The region became infected due to practices during surgery.However, the nature of the implant may have further exacerbated the issue due to it's "hyper" mobility and lack of blood supply to the area.I had a cervical fusion performed in (b)(6) 2023 with explant of the offending device by a neurosurgeon at a hospital.A significant amount of scar tissue was removed from the area and the surgeon performing the explant and fusion informed me that because the simplify device had not attached (with erosion of c5-c6 vertebrae due the infection) there was no support in the area and i could have permanently damaged my spinal cord (leading to potential paralysis or worse) if this had been addressed any later.Since we're talking about my cervical spine paralysis could potentially have been significant.Also, a fusion (even though it's a tried and true method) prevents mobility of the fused vertebrae so now i have permanently lost some mobility in my neck.I have since had to complete 6 weeks of iv antibiotics, taken a 3 month medical leave from work, and continue to be on a maintenance dose of oral antibiotics to try to keep any residual infection at bay.I also have to wait and hope that c5-c6 fuses and i do not need additional surgery to add more bone to the area.I will also need to complete many weeks of physical therapy and slowly work back up to my previous fitness level.I am a very active person and very physically fit, so this entire ordeal has been a huge detriment to my life.I was made to feel that the newest implant on the market would probably be the best, but clearly the kinks have not all been worked out and surgeons using these implants may be overzealous to complete post market studies rather than consider the best interest of patients.I hope others who have had issues speak up to the fda.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.
• MDR Report Key: 17389652
• MDR Text Key: 319800339
• Report Number: MW5119995
• Device Sequence Number: 1
• Product Code: MJO
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CLONAZEPAM (LOW DOSE) FOR SLEEP AND BREATHING. ; IBUPROFEN (FOR HEADACHES); INSPIRE DEVICE FOR SLEEP APNEA.; MANY VITAMINS BUT NOTHING UNUSUAL
• Patient Outcome(s): Life Threatening; Disability; Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White