MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PEEK CORPECTOMY RAILED SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	5991220
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Paralysis (1997)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No details have become available to better describe the event and specific circumstances that led to the reported injury.No product has been returned for evaluation.Indications for use: "the nuvasive monolith corpectomy system is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (t1 to l5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues.".
Event or Problem Description
Received a voluntary event report (mw5071101) stating: patient underwent a single-level c6 anterior cervical corpectomy and fusion using a monolith device.Paralysis reportedly resulted from the procedure.Patient underwent an unspecified revision procedure six months post-surgery.

• Brand Name: NUVASIVE PEEK CORPECTOMY RAILED SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6837753
• Report Number: 2031966-2017-00116
• Device Sequence Number: 569364
• Product Code: MQP
• UDI-Device Identifier: 00887517676931
• UDI-Public: 00887517676931
• Combination Product (Y/N): N
• PMA/510(K) Number: K151538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2017

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: 5991220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 09/01/2017
• 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: Hospitalization; Required Intervention