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	12/23/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation nor were x-rays provided to confirm 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.".
Event or Problem Description
On (b)(6) 2011, a patient underwent an interlaminar lumbar instrumented fusion at l4-5 levels.On (b)(6) 2011, the patient was treated for a superficial wound infection.The patient underwent an incision and drainage of the wound.
Additional Manufacturer Narrative
Supplemental report submitted to update.Event is a serious injury and not a product malfunction.

• 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: 6980097
• Report Number: 2031966-2017-00143
• Device Sequence Number: 19341942
• Product Code: KWP
• UDI-Device Identifier: 00887517062352
• UDI-Public: 00887517062352
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 01/10/2018

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: 7577045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2012
• Supplement Date Received by Manufacturer: 04/05/2012
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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: Required Intervention
• Patient Age: 58 YR