MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE 4.5-5.0 SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 13450000

Device Problem Expulsion (2933)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

The lock screw was not received for evaluation; however, radiographs provided confirmed the alleged lock screw expulsion and examination of the other lock screw expelled (see report # 2031966-2022-00045), revealed no damage to the helical flange/threads, starting thread, or internal lock screw features.Additionally, the inferior side of the lock screw was devoid of contact marks (with the rod), which are expected when the required 70 in/lb torque off is completed, indicating insufficient torque as the cause.This is also likely the cause for the screw that is the subject of this report.Manufacturing review: review of the device history record notes no material non-conformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to the event.Parts met acceptance criteria upon release.Labeling review: ".Final tightening: all lock screws must be tightened to a torque of 70 in-lbs.Attach the torque handle to the final lock screw driver.Slide the counter-torque over the tulip until the instrument bottoms out.Insert the final lock screw driver through the counter-torque, and seat into the lock screw.Turn the torque handle clockwise until the breakaway torque is reached.Repeat on each screw." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Post-operative warnings: during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components.Loss of fixation." ".Warnings, cautions and precautions: the implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Growing rod constructs step 12: utilize the torque t-handle, final driver, and counter torque to final-tighten the lock screws and lock down the construct.".

Event Description

During a post-op follow-up, a physician noticed that two (2) reline 4.5/5.0mm rss lock screws had come loose causing the inferior end of a rod to become free-floating in the patient.A revision surgery was performed and the loose lock screws were removed and new lock screws were placed.The patient did not experience any adverse symptoms.Report 2 of 2.

• Brand Name: NUVASIVE RELINE 4.5-5.0 SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13595936
• MDR Text Key: 290550642
• Report Number: 2031966-2022-00046
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517766021
• UDI-Public: 887517766021
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190636
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13450000
• Device Lot Number: SA4903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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
• Treatment: MAGEC 2B ROD, P/N MC2-5090R
• Patient Outcome(s): Hospitalization
• Patient Sex: Prefer Not To Disclose