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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

No product returned for evaluation as it was left in-situ.No radiographs or images provided so the complaint could not be confirmed.Review of the reported event and surgeons notes identified complete fusion had taken place and no revision procedure was required.No additional investigation required.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant , component(s).Loss of fixation.".

Event Description

On (b)(6) 2016, a patient underwent an xlif procedure at l4-5.Postoperatively, the coroent xl cage migrated.Surgically intervention was not needed as the levels had already fused together.The cage remains in-situ.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT THORACOLUMBAR SYSTEM, COROENT
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 11220678
• MDR Text Key: 241237710
• Report Number: 2031966-2021-00015
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K203201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention