MAUDE Adverse Event Report: NUVASIVE, INC. COROENT XL WIDE, 10X22X50MM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6910250
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the interbody fractured during implantation.All pieces were retrieved and there was no adverse impact to the patient, user, or procedure.No additional information is available.
Additional Manufacturer Narrative
The device has been received and is pending evaluation.A review of the device history record was performed and no discrepancies were found.A supplemental report will be filed upon completion of the investigation or if any additional, relevant information becomes available.Labeling review: ".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.".
Additional Manufacturer Narrative
The device was received by nuvasive and confirmed the complaint.Review of the complaint statement identifies the device fractured during implantation as a result of angulation required due to anatomical challenges.Review of the returned device identified a large piece of peek fractured off on either side of the attachment feature with substantial deformation indicating off axis force applied.Root cause is considered to be related to technique, which can be the consequence anatomical characteristics of the patient.Manufacturing review: review of the device history record notes no material non-conformances, 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 (b)(4).You may also email: (b)(4).This instructions for use document is intended for the us market only.For ous instructions for use, please refer to document # (b)(4) for non-sterile implants and #(b)(4) for sterile implants." (b)(4).

• Brand Name: COROENT XL WIDE, 10X22X50MM
• 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: 17552435
• Report Number: 2031966-2023-00171
• Device Sequence Number: 6967153
• Product Code: MAX
• UDI-Device Identifier: 00887517390523
• UDI-Public: 887517390523
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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: 6910250
• Device Lot Number: NU9526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2023
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2016
• 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