MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT XL INTERFIXATED SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6980850
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned as it was discarded after use.Photograph provided confirmed the complaint.Review of the provided photograph and other similar events identify the fracture as a result of implant selection, insufficient or overtightening of the inserter, insufficient disc space prep and or excessive off-angled force while malleating all related to technique as the root cause of the failure.No additional investigation necessary.Labeling review: ".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.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.Care should be taken to ensure that all components are ideally fixated prior to closure." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." device not returned.
Event or Problem Description
On (b)(6) 2023 during a spinal procedure the surgeon announced the implant had cracked whilst inserting into the disc space using a hammer.The implant pieces were removed and the remainder of the cage piece was removed from the disc space with the removal tool.Another cage was implanted.The removal and alternate cage being implanted resulted in 5 min addition to surgery time.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: COROENT XL INTERFIXATED SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 16257080
• Report Number: 2031966-2023-00010
• Device Sequence Number: 14873498
• Product Code: MAX
• UDI-Device Identifier: 00887517403209
• UDI-Public: 887517403209
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6980850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose