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

Model Number	7180027006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	12/24/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon reported the corpectomy was completed with the surgeon's/hospital's own chisel.The implant was not returned for evaluation.No further investigation can be completed at this time.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: warnings, cautions and precautions: "potential risk identified with the use of this device system, which may require additional surgery include: device component fracture, loss of fixation, non-union, fracture of the vertebra, spinal cord or nerve root injury, nerve damage due to surgical trauma, paralysis, neurological injury and vascular or visceral injury".
Event or Problem Description
On (b)(6) 2015 a female patient under went an xlif procedure for corpectomy at l1.After placing the xcore ii the surgeon was removing the posterior vertebral wall when the chisel accidently entered the spinal canal and spinal fluid leaked.Mep amplitude decreased but waveform was displayed until closure of the incisions.Following corpectomy, posterior decompression and spinal cord repair was performed.During follow-up the patient reportedly developed paralysis of the lower extremities.

• Brand Name: 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: 5375640
• Report Number: 2031966-2015-00094
• Device Sequence Number: 19005508
• Product Code: MQP
• UDI-Device Identifier: 00887517426505
• UDI-Public: 00887517426505
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 7180027006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability