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

Model Number	6111055
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.Labeling review: ".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." ".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage." ".Pre-operative warnings: care should be used in the handling and storage of the coroent implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial extreme lateral interbody fusion procedure.During the procedure, at an unknown step, the implant broke near the proximal interface with the inserter.Information regarding the nature of the implant breakage and if there was any impact to the patient or procedure was requested but was not provided.No additional information was available.

• Brand Name: NUVASIVE COROENT 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: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16745031
• Report Number: 2031966-2023-00082
• Device Sequence Number: 20444546
• Product Code: MAX
• UDI-Device Identifier: 00887517288004
• UDI-Public: 887517288004
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 6111055
• Device Catalogue Number: N/A
• 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: 03/21/2023
• Initial Report FDA Received Date: 04/14/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose