MAUDE Adverse Event Report: NUVASIVE, INC. ALIF INTERFIXATED SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	6955252
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation.A review of the radiograph provided confirmed screw and spacer migration.The root cause of this event has not been determined.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" still in-situ.
Event or Problem Description
On (b)(6) 2017 a (b)(6) y/o female underwent a vertebral body replacement.On (b)(6) 2017 follow up radiographs showed the interfixated screw backing out and cage migration at l4-l5.As per initial reporter no revision procedure is planned at this time.

• Brand Name: ALIF INTERFIXATED SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6583711
• Report Number: 2031966-2017-00053
• Device Sequence Number: 13592165
• Product Code: OVD
• UDI-Device Identifier: 00887517701831
• UDI-Public: 00887517701831
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151214
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

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: 6955252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR