MAUDE Adverse Event Report: NUVASIVE, INC. SPINOUS PROCESS PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7577045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/21/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation as it remains in-situ.No product malfunction reported related to the event.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." product remains in-situ.
Event or Problem Description
On (b)(6) 2011 a patient underwent an interlaminar lumbar instrumented fusion at l4-5 levels.Six weeks post index surgery patient was diagnosed with superficial wound infection and seroma.Patient was hospitalized for wound drainage and treated with antibiotics.

• Brand Name: SPINOUS PROCESS PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6985301
• Report Number: 2031966-2017-00138
• Device Sequence Number: 18957037
• Product Code: KWP
• UDI-Device Identifier: 00887517062352
• UDI-Public: 00887517062352
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K073278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 7577045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2011
• Initial Report FDA Received Date: 10/27/2017
• 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: 61 YR