MAUDE Adverse Event Report: NUVASIVE, INC. COROENT XL+, 10X18X50MM 10°; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC

Model Number 6310850006P2

Device Problem Fracture (1260)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Photographs of the fractured portion were received and evaluated, and confirmed the reported fracture at the inserter attachment point; the fractured portion consisted of material at and adjacent to the threaded inserter attachment point.Because of the amount of peek material between the threaded inserter attachment hole and the outer edge of the cage, the disc space must be properly trialed and distracted in order to prevent damage to or fracture of the implant during insertion impaction.Additionally, coroent xl+ cages are intended to be used with interbody slides or a distractor tool in order to prevent their fracturing during impaction.While a definitive cause cannot be determined, cage fractures may occur due to off-axis forces applied with in-situ twisting of the implant (done to maximize distraction of the disc space in an attempt to restore proper spacing of the vertebral bodies), may occur due to off-axis impact with a mallet, may occur due to micro motion at the implant-inserter interface if the cage is not fully threaded onto the inserter, and/or may occur if the cage is over-tightened onto the inserter.Manufacturing record review: review of the device history records noted no material non-conformances, no manufacturing errors, and no discrepancies related to the reported issue.The lot met acceptance criteria upon release.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include:.Bending, fracture or loosening of implant component(s).".".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.".".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.".".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.".".Compatibility: all implants should be used only with the appropriately designated instrument (reference surgical technique) ¿".".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".".Handling of the sterile implant: open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used.".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

It was reported that during an extreme lateral interbody fusion procedure, the cage fractured at the inserter attachment point during insertion at l3/4.The fractured piece was removed but the remaining portion of the cage was left in-situ.There was no reported adverse impact to the patient, user, or procedure.No additional information is available.

• Brand Name: COROENT XL+, 10X18X50MM 10°
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, THORACIC
• 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: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 18480707
• MDR Text Key: 332923200
• Report Number: 2031966-2024-00007
• Device Sequence Number: 1
• Product Code: PHM
• UDI-Device Identifier: 00887517661357
• UDI-Public: 887517661357
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6310850006P2
• Device Lot Number: N310872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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 Sex: Female