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

Model Number	4083424
Health Effect - Clinical Code	Collapse (2416)
Date of Event	12/15/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs received confirmed the implant migrated 1-2 mm posterior but is still contained within the disc space and that no portion of the implant has collapsed.The device remains in-situ and has not been returned.No further evaluation of the product can be completed at this time.It is unknown if endplate preparation, placement, or the patient's bone integrity contributed to the event.The root cause of this reported event has not been determined, no conclusion can be drawn.Product labeling indicates: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury and vascular or visceral injury.Remains in-situ.
Event or Problem Description
(b)(6) female patient at l4-s1 had a expandable lumbar interbody system with bilateral pedicle screws placed on (b)(6) 2015.Two months post-operatively the device was reported to have migrated and possibly collapsed.The surgeon has elected to monitor the patient as the implant is fusing in place.No revision surgery is planned at this time.Patient is asymptomatic and doing well.

• Brand Name: EXPANDABLE LUMBAR INTERBODY 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: 5362498
• Report Number: 2031966-2015-00091
• Device Sequence Number: 32451
• Product Code: MAX
• UDI-Device Identifier: 00887517264497
• UDI-Public: 00887517264497
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• 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
• Report Date (Section B): 01/11/2016

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: 4083424
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR