MAUDE Adverse Event Report: NUVASIVE, INC XCORE VERTEBRAL BODY REPLACEMENT DEVICE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	5964152
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not received and the event could not be confirmed.The explanted device has not returned.The root cause of this reported event has not been determined.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 of fixation, nonunion or delayed union, fracture of the vertebra, implant subsidence".
Event or Problem Description
On (b)(6) 2016, a patient underwent a vertebral body replacement (vbr) at t8.It was reported the implant did not lock and reduced height postoperatively.A revision surgery was performed on (b)(6) 2016.

• Brand Name: XCORE VERTEBRAL BODY REPLACEMENT DEVICE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6141515
• Report Number: 2031966-2016-00087
• Device Sequence Number: 1248716
• Product Code: MQP
• UDI-Device Identifier: 00887517270887
• UDI-Public: 00887517270887
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K090176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: 5964152
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1