MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE X-CORE EXPANDABLE VBR SYSTEM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7160025
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a spinal procedure the interbody was placed on l1, but could not be expanded.It was removed and replaced with no additional issues reported.
Additional Manufacturer Narrative
No device was returned as it was discarded at the user facility and image of inserter was provided although the complaint cannot be confirmed from the image.Review of the reported event and other similar events suggest this issue may be the result of a known failure mode where the inserter is attached and turned backwards past the starting point with force, or the core is expanded then retracted with force damaging the device and disallowing further expansion.Due to a lack of information provided no root cause can be determined.Should additional information be provided another report will be filied.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery."."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."."method of use please refer to the surgical technique for this device." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative." 9402094-en c-09/2018 h3 other text : device discarded at user facility.

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18881867
• Report Number: 2031966-2024-00078
• Device Sequence Number: 21146252
• Product Code: MQP
• UDI-Device Identifier: 00887517424228
• UDI-Public: 887517424228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/11/2024

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: 7160025
• Device Lot Number: ST163610
• 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: 02/16/2024
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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: D7165100
• Patient Sex: Female
• Patient Weight: 40 KG