MAUDE Adverse Event Report: NUVASIVE, INC. SPINAL INTERLAMINAL FIXATION ORTHOSIS; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7577045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	07/18/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There is no known product malfunction reported no product being returned for investigation as it remains in-situ.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 interlaminar lumbar instrumented fusion.During post-op visit an infection and hematoma were noted.An incision and drainage of the wound were performed.Patient was treated with iv and antibiotics.

• Brand Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6976038
• Report Number: 2031966-2017-00137
• Device Sequence Number: 13820415
• 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): 10/25/2017

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: 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: 10/25/2017
• 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: 80 YR