MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PEEK CORPECTOMY RAILED SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	5991416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Damage to Ligament(s) (1952); Injury (2348)
Date of Event	06/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it remains in-situ.No product malfunction reported.Surgical incision is healing well and no evidence of infection has been reported.Potential adverse events and complications: "as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries.".
Event or Problem Description
On (b)(6) 2017, a patient underwent an anterior cervical discectomy on c6-c7 level, corpectomy c4 with insertion of monolith cage.During index procedure the dura proper was damaged and the arachnoid membrane was exposed; collagen and thrombin, were placed in an attempt to seal disk space.Two days post index surgery patient returned to the operating room due to cerebral spinal leak in the cervical area.Patient is reported to be healing well.

• Brand Name: NUVASIVE PEEK CORPECTOMY RAILED SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7037052
• Report Number: 2031966-2017-00165
• Device Sequence Number: 1275872
• Product Code: MQP
• UDI-Device Identifier: 00887517677150
• UDI-Public: 00887517677150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2017

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: Physician
• Device Model Number: 5991416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/16/2017
• 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
• Patient Age: 55 YR