MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT THORACOLUMBAR IMPLANTS; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number 6309850006P2

Device Problem Malposition of Device (2616)

Patient Problem Damage to Ligament(s) (1952)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

No device was returned as no device fault was alleged.No imaging could be provided confirming the alleged complaint.Review of the reported event identified the surgeon misplaced the interbody cage and inadvertently damaged the patients ligament requiring the implant to be removed to be replaced at a later date modifying the procedure.No additional investigation required.Label review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." "potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury." "warnings, cautions and precautions the subject device is intended for use only as indicated.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) 2024 a lateral interbody fusion procedure was performed from l2 to l5.While placing the vertebral spacer at the l4/5 level it was believed that the device was positioned to far anteriorly potentially injuring the anterior longitudinal ligament but it could not be confirmed.No adverse patient consequences reported.It was reported the cage was removed with plans to implant a replacement at a later date.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR IMPLANTS
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: dean lucas ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19127595
• MDR Text Key: 340446680
• Report Number: 2031966-2024-00112
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517661258
• UDI-Public: 887517661258
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150994
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6309850006P2
• Device Lot Number: N323629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• 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 Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Male