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

Model Number 6955221

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation as product remains in-situ nor were radiographs or images provided that confirm the alleged event.It is unknown if fusion was successful nor if patient conformed to post-operative physical restrictions.The root cause is unknown at this time.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.".".Contraindications include but are not limited to: patients who are unwilling to restrict activities or follow medical advice.".".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant.".

Event Description

On (b)(6) 2016 patient underwent a anterior lumbar interbody fusion procedure without any reported issues.On (b)(6) 2018 radiographs identified a fractured inter-fixation screw.No patient injury reported nor revision procedure planned.

• 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; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 8075627
• MDR Text Key: 128276121
• Report Number: 2031966-2018-00167
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6955221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2018
• 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