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

Model Number	7180033
Medical Device Problem Codes	Detachment Of Device Component (1104); Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/04/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5904074
• Report Number: 2031966-2016-00063
• Device Sequence Number: 5647
• Product Code: MQP
• UDI-Device Identifier: 00887517426512
• UDI-Public: 00887517426512
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial 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
• Operator of Device: No Information
• Device Model Number: 7180033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2016
• Initial Report FDA Received Date: 08/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR