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

Model Number	5991417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as it remained in-situ.No radiographs were provided to confirm the event.Labeling review.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 include: early or late infection." ".Potential risks identified with the use of this system, which may require additional surgery, include: infection." ".Patient education: the patient should be made aware of the limitations of the implant and potential risks of the surgery." postoperative warnings: "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." cleaning and decontamination: "all instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions.".
Event or Problem Description
On (b)(6) 2017, a patient underwent an anterior cervical discectomy c3-c4, c4-c5 levels and corpectomy of c4 with insertion of monolith cage.No complications were reported during surgery.On (b)(6) 2017, patient developed malaise and began drainage from neck.Patient was re-admitted to the hospital on (b)(6) 2017 with diagnosis of wound seroma.Patient was taken to the or and prior incision was opened.Pulse lavage with 4 liters of normal saline and debridement of wound.The deep drain was replaced.

• 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: 7033142
• Report Number: 2031966-2017-00164
• Device Sequence Number: 156431
• Product Code: MQP
• UDI-Device Identifier: 00887517677167
• UDI-Public: 00887517677167
• 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): 11/15/2017

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: 5991417
• 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: 11/15/2017
• 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: 63 YR