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

Model Number 10060445

Device Problem Positioning Failure (1158)

Patient Problem Vertebral Fracture (4520)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

Two (2) cross-connectors were returned to nuvasive.It is unknown which device malfunctioned intra-operatively.Lot number n268872 or n221994.Device msep (b)(6) 2020 or (b)(6) 2018 the complaint devices, two (2) cross-connectors and one (1) 40in-lb torque handle, were evaluated and the reported event was confirmed.The evaluation identified that the locking cams on both connectors exhibited severe deformation to the hexalobe drive features as well as dislocation of the cam component in the arm assemblies.It could not be determined if the damage occurred during the reported locking failure of the device or during removal.However, the torque handle used with the fractured driver was determined to be damaged and out of calibration, allowing excessive torque force to be applied.A review of the device history records was performed and no discrepancies were found.The cause of the device failures was determined to likely be excessive force applied by the damaged handle.Labeling review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra." ".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." ".Pre-operative warnings: 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

It was reported that that patient underwent an initial posterior fixation procedure.During the procedure, as the surgeon attempted to tighten the locking cam of the cross connector on the rod, the cam spun and was unable to be tightened.Subsequently, the surgeon encountered difficulties in removal of the connector and had to use a leskal to rip the device out of the construct, resulting in a broken pedicle.As a result, the fusion had to be extended.No further patient impact was reported.

• Brand Name: NUVASIVE RELINE OPEN 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: 15442596
• MDR Text Key: 300121987
• Report Number: 2031966-2022-00183
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517535078
• UDI-Public: 887517535078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10060445
• Device Catalogue Number: N/A
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: TORQUE HANDLE, 40 IN-LB
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose