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

Model Number 6955252

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 04/27/2017

Event Type  malfunction  

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 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
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 6583711
• MDR Text Key: 75723389
• Report Number: 2031966-2017-00053
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517701831
• UDI-Public: 00887517701831
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6955252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR