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

Model Number 16171111

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024 a transforaminal lateral interbody fusion was conducted at l4/s1.On (b)(6) 2024 it was discovered the screw shank separated at l4.No patient injuries were reported.No revision reportedly performed.

Manufacturer Narrative

The device is in-situ, but images provided confirmed the complaint.Review of the images provided identified the tulip head on the left cranial side screw detached from the shank head.No root cause could be determined however review of the reported event, associated technique guide, complaint review, and radiographs provided suggest an incomplete assembly in-situ which can be the result of technique or anatomical obstruction.No additional investigation can be completed at this time.Should the device be returned for evaluation another record will be filed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.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.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." "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." "pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "post-operative warnings.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." 9401879-en p-12/2018 h3 other text : device in-situ.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19089801
• MDR Text Key: 340696780
• Report Number: 2031966-2024-00105
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517587497
• UDI-Public: 887517587497
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K223181
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16171111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• 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
• Treatment: 13177550
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Race: Asian