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

Model Number	4119305P2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while undergoing a transforaminal lumbar interbody fusion procedure the interbody spacer broke during insertion.No information was provided on how the device broke.The device was able to be retrieved with no reported patient impact an no further impact to the procedure.No additional information is available.
Additional Manufacturer Narrative
No device was returned for evaluation and no photographs of the device were provided for review.Additionally, no radiographs or operative notes were provided for review of usage/technique.Based on the information available, the complaint was unable to be confirmed and the cause of the reported event was unable to be determined conclusively; however, off-angled excessive force applied during impaction, in-situ twisting, as well as overtightening of the implant on the inserter may have caused or contributed to the reported breakage.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." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE COHERE THORACOLUMBAR INTERBODY 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: 20904865
• Report Number: 2031966-2024-00335
• Device Sequence Number: 9180486
• Product Code: MAX
• UDI-Device Identifier: 00195377029515
• UDI-Public: 195377029515
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K181860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

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: 4119305P2
• 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: 11/18/2024
• Initial Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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