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

Model Number	7180055
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not received.Revision surgery has not occurred.The surgeon has elected to monitor the patient.No further investigation can be completed at this time.The root cause of this reported event has not been determined; however, the duration-to-failure suggests the possibility of non-union.Labeling review: potential adverse events and complications: "potential risk identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss fixation, nonunion or delayed union, fracture of the vertebra, implant subsidence." warnings, cautions and precautions: "internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." discarded by user facility.
Event or Problem Description
A patient underwent a vertebral body replacement (vbr) on (b)(6) 2014.Approximately 26 months after surgery, it was noted the vbr had reduced in height 5-6mm.Patient is asymptomatic.No revision surgery is planned at this time.

• Brand Name: NUVASIVE X-CORE(R) 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: 6349826
• Report Number: 2031966-2017-00002
• Device Sequence Number: 10900532
• Product Code: MQP
• UDI-Device Identifier: 00887517426536
• UDI-Public: 00887517426536
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Physician
• Device Model Number: 7180055
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2016
• Initial Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1