MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT THORACOLUMBAR INTERBODY; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number 6007850006P2

Device Problem Fracture (1260)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported that the patient underwent an initial two (2) level extreme lateral interbody fusion at l2/l3 and l3/l4.During the procedure, as the surgeon inserted the interbody cage into the l2/l3 disc space, the device fractured.The cage was retrieved, but not all fragments were able to be located.The procedure was completed using a new interbody device.No patient consequences have been reported as a result of the malfunction.

Manufacturer Narrative

No device was returned to nuvasive for evaluation; the reported event was confirmed by review of a photograph of the retrieved device.Operative notes and/or radiograph images were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components." ".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.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.Care should be taken to ensure that all components are ideally fixated prior to closure." ".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." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR INTERBODY
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13518904
• MDR Text Key: 287130510
• Report Number: 2031966-2022-00041
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517660602
• UDI-Public: 887517660602
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6007850006P2
• Device Catalogue Number: N/A
• Device Lot Number: ML6937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female