MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6308850006P
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	11/26/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No radiographs were provided to confirm event.No product was returned.No information was given on instrumentation involved.Patient noted to be a very thin female.No notification of failure related to any nuvasive devices were noted.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; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s).Loss of fixation.Nonunion or delayed union.Fracture of the vertebra.Neurological, vascular or visceral injury.Metal sensitivity or allergic reaction to a foreign body.Infection.Decrease in bone density due to stress shielding.Pain, discomfort or abnormal sensations due to the presence of the device.Nerve damage due to surgical trauma.Bursitis.Dural leak.Paralysis.Death.Still in-situ.
Event or Problem Description
On (b)(6) 2015 a female patient underwent a xlif procedure on the right side with no problems or issues noted at time of surgery.Post-operatively the patient complained of abdominal discomfort for which a laparotomy was performed.During the procedure a 5mm hole was discovered in the ascending colon which was cleansed and sutured.Patient condition improved.No additional patient injury reported.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5345741
• Report Number: 2031966-2015-00088
• Device Sequence Number: 10845799
• Product Code: MAX
• UDI-Device Identifier: 00887517305473
• UDI-Public: 00887517305473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/05/2016

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: 6308850006P
• Device Lot Number: QT44758B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/05/2016
• 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; Other