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

Model Number	6080823
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implant was not returned but radiographs confirmed the event.The implant remains in-situ and no further investigation can be completed at this time.It is unknown if the patient complied with post-operative instructions.Patient did not sustain a fall or injury but did complain of pain.Root cause has not be determined, no conclusion can be drawn.Review of labeling notes: warning and cautions and precautions: "potential risks identified with the use of this device 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, pain, discomfort or abnormal sensations due to the presence of the device." device remains in-situ.
Event or Problem Description
On (b)(6) 2015 a (b)(6) male had an intervertebral fusion device placed at l5-1.The cage looks to have migrated posteriorly into the vertebral foramen.Patient reported pain, but did not sustain a fall or injury.The surgeon has elected to monitor the patient.No revision surgery has been scheduled at this time.

• 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: 5536769
• Report Number: 2031966-2016-00021
• Device Sequence Number: 16242641
• Product Code: MAX
• UDI-Device Identifier: 00887517283405
• UDI-Public: 00887517283405
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 6080823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR