MAUDE Adverse Event Report: NUVASIVE, INC. X- CORE VERTEBRAL BODY REPLACEMENT DEVICE; SPINAL VERTEBRAL BODY REPLACEMENT

Model Number 7180041

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Post-surgery and event radiographs were received and the event was confirmed.No product has been explanted.It is not known if the loosening of the screw from infection may have contributed to the collapse of the core disc height.Review of the device history records notes no material non-conformances or manufacturing errors that may have caused or contributed to this mode of failure.Device will not be returned and no further investigation can be completed at this time.Root cause has not been determined.

Event Description

On (b)(6) 2014 subject was implanted with a nuvasive vertebral body replacement device at l3 along with synthes screws.Three months post op on 01/26/2015 during a routine follow up visit it was determined that the vbr collapse of core height had taken place along with the synthes screw loosening distal with infection of one screw channel.Patient is asymptomatic.There is no plan for revision surgery.Patient impact/sustained fall or other factors contributing to a failure are unknown.

• Brand Name: X- CORE VERTEBRAL BODY REPLACEMENT DEVICE
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 4545 towne centre court; san diego CA 92121
• Manufacturer Contact: deborah silva ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 4863267
• MDR Text Key: 22470209
• Report Number: 2031966-2015-00028
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7180041
• Device Lot Number: DR5293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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 Age: 45 YR