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

Model Number 6955202

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 12/12/2017

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.No radiographs or photographs were provided to confirm the reported event.Labeling review: ".Step 3: bolt placement (cont.) both straight and angled bolt drivers have a green fluorescent color band that functions as a visual indicator for proper bolt seating.Once the bolt head engages into the bolt pocket, the green fluorescent color band will no longer be visible (fig.8).Now the bolt is fully seated in the bolt pocket.For optimal results, maintain consistent, coaxial pressure throughout bolt insertion.While bolt driver remains attached to the bolt head, remove hex handle and replace with the appropriate torque handle (fixed or variable) at the proximal end of the shaft to confirm a secure fit.Note 30 in./lb.Torque handle is used with fixed bolts.Eight in./ lb.Torque handle is used with variable bolts.Note bolt removal or fine-tune adjustments are done with bolt adjusters (straight or angled) and set screw adjusters (straight or u-joint).Proceed to turn the handle clockwise to drive the set screw.As the set screw flanges begin to deploy, a tactile torque spike will be felt.Continue driving down the set screw until the handle "breaks away" and an audible "click" sound is heard.Now the set screw flanges are fully deployed and the bolt is locked in the bolt pocket (fig.9).Repeat technique for remaining bolts.To remove implant inserter, rotate thumbwheel counterclockwise until inserter is returned to an unlocked position.Carefully remove the implant inserter from the implant and operative site." ".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.".".Care should be taken to insure that all components are ideally fixated prior to closure." device was left in-situ.

Event Description

On (b)(6) 2017 a patient underwent an anterior lumbar interbody fusion procedure with posterior fixation at l5-s1 levels with no reported issues.On (b)(6) 2017 a follow up radiograph revealed one of the inferior fixation screws had backed out.No revision procedure is planned at this time.No patient injury was reported.

• 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: 7162859
• MDR Text Key: 96396114
• Report Number: 2031966-2017-00195
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517701749
• UDI-Public: 00887517701749
• 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: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 6955202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• 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: 49 YR