MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number 7180025

Device Problems Collapse (1099); Device Slipped (1584)

Patient Problem Failure of Implant (1924)

Event Date 10/01/2014

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as it remains in-situ.Radiographic images have been provided which confirm the alleged event.Warnings, cautions and precautions ".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." ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." remains in-situ.

Event Description

In (b)(6) 2014, a patient underwent a vertebral body replacement procedure.In a follow up exam it was discovered that the implant had experienced height loss.The patient is currently asymptomatic and there are no plans for revision surgery.

• Brand Name: NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 6772800
• MDR Text Key: 82780329
• Report Number: 2031966-2017-00099
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00887517426291
• UDI-Public: 00887517426291
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2017

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
• Device Operator: No Information
• Device Model Number: 7180025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 84 YR