MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180027006

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

No implant has been returned.No radiographs have been received.The reported event was not confirmed and no root cause can be determined at this time; however, review of reported information is consistent with the event being caused by the degree of distraction associated with the posterior fixation placement.Revision surgery in the form of vbr replacement occurred.No further investigation can be completed at this time.No patient injury has been reported.Discarded by user facility.

Event Description

On (b)(6) 2016 a female patient underwent vertebral body replacement at l1 no reported issues.On (b)(6) 2016 supplemental posterior fixation was performed.During placement of the posterior fixation, an overcorrection of the curve at l1 created a gap between the implant and disk.On (b)(6) 2016 a revision took place to remove and replace the implant with a larger size.No patient injury was reported.

• Brand Name: NUVASIVE X-CORE(R) EXPANDABLE VBR SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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 ; 8588825019
• MDR Report Key: 6244583
• MDR Text Key: 64620677
• Report Number: 2031966-2016-00094
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142205
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/11/2017

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: Physician
• Device Model Number: 7180027006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2016
• 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