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

Model Number 12360500

Device Problem Misassembled During Installation (4049)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

No product was returned as the explanted device was disposed of at the facility.No radiographs were provided confirming the device failure.The patient is recovering well post revision.Review of the provided information suggests the root cause of the issue is user error during installation as it was admitted that the device was misassembled during installation.No additional investigation can be completed."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 include.Potential risks identified with the use of this system, which may require additional surgery, include:.Bending, fracture or loosening of implant component(s).Loss of fixation." ".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.".

Event Description

On (b)(6) 2021 a patient underwent a posterior fixation procedure from t10-l5.In july on a unknown date during a routine post op follow up a radiograph revealed that the that the rod was installed in reverse against the curvature.According to information received, the bent rod was almost straight and so the screws were not loose and the patient had no pain.On (b)(6) 2021 a revision occurred where the device was replaced with a new rod.The revision operation was successfully completed and the patient is recovering well.

• 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 lucas ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 12345295
• MDR Text Key: 267453462
• Report Number: 2031966-2021-00102
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517507648
• UDI-Public: 887517507648
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12360500
• Device Lot Number: CT144476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1