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

Model Number 13550000

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

No product was received as the involved materials remain in-situ and no radiographs could be provided confirming the alleged issue.The lock screws were tightened off by hand and the surgeon failed to completed final tightening with the 90in-lb torque handle.The root cause of the issue it incorrect procedural method as all of the lock screws are required to be tightened using counter-torque and torque t-handles.No additional investigation will take place.Label review: "potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." "all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.".

Event Description

On (b)(6) 2021 a patient underwent a spondylectomy procedure at l3 with posterior fixation from t12 to l5.The surgery was completed without issue.Within 1-2 hours after the surgery the physician stated that the construct lock screw were not torqued off.For unknown reasons during the initial procedure the screws were only hand tightened.On (b)(6) 2021 a revision occurred were the screws were all retightened with a torque handle.The patient is/was asymptomatic and it reported to be recovering.

• Brand Name: NUVASIVE RELINE 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: 13176294
• MDR Text Key: 283319156
• Report Number: 2031966-2022-00004
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K143684
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13550000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose