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

Model Number 7180033

Device Problems Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

Radiographs confirmed l3 inferior endplate fracture with subsidence of the x-core vbr superiorly into the l3 vertebral body with anterior and lateral displacement and disassembly of the inferior endcap from the core component.The inferior endcap lock screw is not visible.It cannot be determined based on these radiographs whether the endcap lock screw failed (e.G., fractured) or was not employed.Device remains in-situ.Revision surgery is scheduled for (b)(6) 2016.Patient did not undergo any impact/sustained fall or other factors contributing to a failure.The root cause of this reported event has not been determined; no conclusion can be drawn; however, the endplate fracture and subsidence may have contributed to the event.Review of labeling notes: "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; nonunion or delayed union; fracture of the vertebra.Device remains in-situ.

Event Description

A (b)(6) year old female patient underwent surgery on (b)(6) 2016.During a routine post-operative check-up radiographs showed that the x-core 2 ti core, 18 x 24-33mm reportedly had dispensed from the cage.Removal of the complete implant is scheduled for september.No patient injury was reported.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5904074
• MDR Text Key: 53045410
• Report Number: 2031966-2016-00063
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00887517426512
• UDI-Public: 00887517426512
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142205
• 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

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: No Information
• Device Model Number: 7180033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2016
• Initial Date FDA Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR