MAUDE Adverse Event Report: NUVASIVE INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 16191111

Device Problems Break (1069); Misassembled During Installation (4049)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation as it remains in-situ.Radiographs provided confirm the alleged event.Labeling review: ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument." ".Preoperative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Note: check both reduction extensions after removal for the black lasermark at the distal end of the reduction extension to ensure the reduction extension has broken off at the correct spot (fig.12).Note: be sure the lock screw is fully seated and the rod is fully reduced prior to breaking off the reduction extensions.".

Event Description

On an unknown date a patient underwent a posterior procedure at l4-s1 without any reported incidents.During a postoperative visit the reduction extension tabs were discovered still in-situ.No revision procedure is currently planned.

Event Description

Supplemental report submitted.

Manufacturer Narrative

Review of the reported event describes the reduction tab fractured off above the desired location and the tab comparison process outlined in the instructions for use was not completed resulting in the fractured tab being left in-situ.Surgeons perogative was not to revise and leave as is.No additional investigation required.Labeling review: "note: be sure the lock screw is fully seated and the rod is fully locked down.".

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9703324
• MDR Text Key: 183103422
• Report Number: 2031966-2020-00027
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517655806
• UDI-Public: 887517655806
• Combination Product (y/n): N
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16191111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR