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

Model Number	7220033
Medical Device Problem Codes	Fracture (1260); Device Slipped (1584)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received and confirmed the event.Revision surgery occurred; however, the implants were not returned for evaluation.No further investigation can be completed at this time.The root cause of this reported event has not been determined.Trend review indicates no adverse trend exists for the fault type.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." not returned.
Event or Problem Description
On (b)(6) 2015, a patient underwent a corpectomy during which a vertebral body replacement (vbr) device was implanted at the t-12 disc space.In addition, posterior fixation was placed at levels t9-l4.Approximately 1 year following surgery, it was noted the vbr had reduced in height and two rods appeared to broken close to the l1 connectors.A revision surgery occurred (b)(6) 2016 to remove and replace all the hardware.Patient condition and status of health prior to event is unknown.Patient activity level, bone quality, and compliance with post-surgical instructions are unknown.

• Brand Name: XCORE VERTEBRAL BODY REPLACEMENT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5752463
• Report Number: 2031966-2016-00052
• Device Sequence Number: 10999377
• Product Code: MQP
• UDI-Device Identifier: 00887517434258
• UDI-Public: 00887517434258
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2016

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: 7220033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 06/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1