MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6921250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Numbness (2415)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation nor were xrays provided to confirm the reported event.No allegation of product malfunction reported.Labeling review: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: loss of sensory and/or motor function." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury." ".Fluoroscopy should be used to verify xlif slides are positioned properly.The inserter is placed with the attached implant between the xlif slides.The implant is advanced across the disc space under a/p fluoroscopy.During insertion of the implant, placement is also monitored with nvm5® free run emg.Generally, the implant spans the ring apophysis, is centered across the disc space from a medial/lateral perspective, and is near the center of the disc space from an anterior/posterior perspective." ".All coroent® xl implants have titanium markers that can be used to confirm correct implant alignment.".
Event or Problem Description
On (b)(6) 2018 patient underwent a two level extreme lateral interbody fusion.Reportedly while inserting the cage at l4/5 levels, the cage was placed too anterior (past the anterior longitudinal ligament), the cage was removed and bone graft was placed within the disc space.After placing a cage at the second level l3/4 an x-ray noted cage was placed too posterior however the surgeons concurred to leave the cage as placed and continue to monitor patient.Patient was reported to have full power in legs and was transferred to the ward for recovery.During the night patient experienced discomfort and started to loose sensation/power in her legs.An mri was carried out next morning and patient underwent a revision procedure where the cage was removed and decompression was performed.Patient is reported to be attending rehab for her legs.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7382753
• Report Number: 2031966-2018-00028
• Device Sequence Number: 13801062
• Product Code: MAX
• UDI-Device Identifier: 00887517394118
• UDI-Public: 00887517394118
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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
• Operator of Device: Physician
• Device Model Number: 6921250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention