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

Model Number	6184000
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received and confirmed the event.Revision surgery occurred and the explanted device was not returned for evaluation.No further investigation can be completed at this time.The root cause of this reported event has not been determined; no conclusion can be drawn.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.".
Event or Problem Description
On (b)(6) 2015, a patient underwent a l1 corpectomy during which a vertebral body replacement(vbr) device was implanted.In addition, posterior fixation was placed at levels t10-l4.Approximately 16 months following surgery, it was noted the set screws were still intact; however, the endcap had separated.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: 5872756
• Report Number: 2031966-2016-00059
• Device Sequence Number: 11055617
• Product Code: MQP
• UDI-Device Identifier: 00887517294326
• UDI-Public: 00887517294326
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 08/09/2016

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: 6184000
• Device Lot Number: DR5717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2016
• Initial Report FDA Received Date: 08/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR