MAUDE Adverse Event Report: NUVASIVE, INC. COROENT XL WIDE, 8X22X60MM LORDOTIC; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6920860P2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and is pending evaluation.A supplemental report will be filed upon completion of the investigation or if any additional, relevant information becomes available.
Event or Problem Description
It was reported that the implant fractured while it was being driven into the disc space via impaction.Reportedly, correct insertion technique was being employed at the time of implant fracture.There was no reported adverse impact to the patient, user, or procedure.No additional information is available.
Event or Problem Description
New or updated information listed on section h10.
Additional Manufacturer Narrative
The device was received by nuvasive and the complaint was confirmed.Review of the returned device found it was fractured at the inserter connection feature.Review of the reported event identified the device fractured during placement while attached to an inserter during impaction.Review of engineering documentation and historical complaint review identified this type of breakage may occur as a result of off-axis forces that promote 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 the mallet, micro motion at the implant / inserter interface if the implant cage is not fully threaded or over tightened onto the inserter indicating technique and excessive force as the root cause, which can be the consequence anatomical challenges of the patient.No additional investigation can be completed.Manufacturing review: review of the device history record notes no material non-conformance, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.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." "method of use: please refer to the surgical technique for this device." "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." "information: to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9402012-en.

• Brand Name: COROENT XL WIDE, 8X22X60MM LORDOTIC
• 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: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 17927482
• Report Number: 2031966-2023-00227
• Device Sequence Number: 6401110
• Product Code: MAX
• UDI-Device Identifier: 00887517993854
• UDI-Public: 887517993854
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2023

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: 6920860P2
• Device Lot Number: ML2634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTER.
• Patient Sex: Prefer Not To Disclose