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

Model Number	6921055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for evaluation however, photographs of the device were provided for review and was able to confirm the reported event.The device appeared to be fractured, per the reported description.Additionally, no operative notes were provided for review of usage/technique.Based on the information available, the cause of the reported event was unable to be determined conclusively, but may have been the result of off-axis forces applied during any in-situ twisting of the implant to maximize distraction of the disc space in an attempt to restore proper spacing of the vertebral bodies, off-axis impact with a mallet, micro motion at the implant / inserter interface if the cage is not fully threaded onto the inserter, and/or over tightening of the cage onto the inserter.Labeling review: ".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.".
Event or Problem Description
During a lumbar procedure when inserting the interbody spacer into the disc space, the device fractured.A second device was used and the case was able to be completed no impact to the patient or case reported.No additional information was provided.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 20510099
• Report Number: 2031966-2024-00278
• Device Sequence Number: 18418344
• Product Code: MAX
• UDI-Device Identifier: 00887517393708
• UDI-Public: 887517393708
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 10/22/2024

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: 6921055
• Device Lot Number: NU20039
• 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: 09/25/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2018
• 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: Unknown