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	Incontinence (1928); Pain (1994)
Date of Event	06/01/2010
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was returned for evaluation as product remains in-situ.Potential adverse events and complications "as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury; pain, discomfort or abnormal sensations due to the presence of the device; nerve damage due to surgical trauma; bursitis.".
Event or Problem Description
During clinical study it was noted that patient had a neurological injury, incontinence.In (b)(6) 2010, the patient underwent surgery to remove bowel blockage and was hospitalized for 1 week.Patient was treated with exercise therapy.

• 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: 6975769
• Report Number: 2031966-2017-00136
• Device Sequence Number: 11080829
• Product Code: KWP
• UDI-Device Identifier: 00887517062352
• UDI-Public: 00887517062352
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K073278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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: 06/07/2010
• 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: Required Intervention
• Patient Age: 81 YR