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

Model Number	6921060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned and no photographs were provided for evaluation.A review of the radiographs provided was able to confirm implant damage as the radiopaque markers were not in the correct position/orientation; however, given the radiopaque nature of the device body, the full extent of the implant damage could not be determined.A review of device manufacturing records was performed and no discrepancies were found.A definitive root cause was unable to be determined with the information provided but is likely the result of excessive use of force or technique.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." ".Pre-operative warnings: 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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
It was reported that during a lumbar spinal surgery an intervertebral spacer broke while being placed in the patient.The broken implant was unable to be removed and was retained in-situ.No further patient impact was reported.No additional information was provided.

• Brand Name: NUVASIVE COROENT XL INTERFIXATED 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: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 19733535
• Report Number: 2031966-2024-00172
• Device Sequence Number: 15456002
• Product Code: MAX
• UDI-Device Identifier: 00887517393715
• UDI-Public: 887517393715
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 07/12/2024

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: 6921060
• Device Lot Number: NU4851
• 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: 03/08/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2014
• 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: Unknown