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

Model Number	4103424
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs confirmed interbody implant subsidence into l4 and l5 vertebral endplates with a protrusion into the spinal canal.It was reported that the patient incurred a fall that caused or contributed to the migration of the device.The device has not been returned and no further investigation can be completed at this time.The root cause of this reported event appears to be related to an impact sustained during activities of daily living.No patient injury was reported.Labeling review: "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." ".The patient's activity level will dictate the longevity of the implant." device has not been received.
Event or Problem Description
On (b)(6) 2017 the patient was implanted with an expandable interbody lumbar system at l4-l5.Since this surgery the patient fell causing the implant to shift posteriorly.Revision surgery was performed on (b)(6) 2017 and the patient is doing well.No patient injury was reported.

• 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: 6452397
• Report Number: 2031966-2017-00028
• Device Sequence Number: 587839
• Product Code: MAX
• UDI-Device Identifier: 00887517265357
• UDI-Public: 00887517265357
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K130820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2017

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: 4103424
• 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: 04/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1