MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 10000607

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/15/2023

Event Type  malfunction  

Manufacturer Narrative

This event was previously reported under medwatch 2031966-2023-00162.This report is being submitted to have an mdr for each k-wire involved.The reported event was confirmed by review of a photograph of the fractured k-wire and radiographs showing the k-wire tip within the vertebral body, anterior to the tip of the pedicle screw.No device was returned to nuvasive qa for evaluation; further, operative notes were not provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided; however, may have resulted from interference between the tip of the screw and the k-wire in-situ.Labeling review: "¿warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." k-wire should be removed when screw has reached the posterior wall of the pedicle to avoid kink in tip.Ensure the k-wire is not advancing as the path is created over the k-wire.Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to confirm proper placement and avoid anterior advancement of the k-wire.".Pre-operative warnings: implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

A spinal procedure was conducted at t11/13.During screw implantation at t12, a piece of the k-wire about 9-10mm in length remained in the vertebrae.Then at t11 this occurred again with a piece about 10mm in length.No pieces were retrieved.No patient injury or consequences reported.Report 2 of 2.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 17760591
• MDR Text Key: 323551616
• Report Number: 2031966-2023-00200
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517512307
• UDI-Public: 887517512307
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10000607
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DRIVER: 10000409
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Race: American Indian Or Alaskan Native, Asian