MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION VU MESH VBR SYSTEM; 12MM SQ CAGE X 15MM LONG

Model Number	15-10-1215
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A patient recently underwent spinal surgery in which seaspine's vumesh vertebral body replacement system was utilized.On (b)(6) 2023.Easpine was notified that during a standard follow-up x-ray, it was detected that a tantalum marker/bead had become detached from the vumesh interbody.
Additional Manufacturer Narrative
The implant and bead remain in the patient and no revision surgery has been scheduled or performed to date.No lot information was made available for the implant, making it challenging to trace any specific manufacturing or quality control issues.There has been no reported injury or adverse event associated with the implant.Additionally, there have been no other complaints for the failure mode or sku.Analysis of the x-ray provided revealed the implant appears to be in its intended position and does not exhibit any obvious signs of fracture or dislodgment.The interbody appears to be structurally intact.There is no evidence of abnormal tissue response or inflammation in the proximity of the implant.There has been no patient injury as a result of the failure reported.Given the limitations of the analysis, a definitive root cause for the reported concern could not be identified.Should additional information become available or if further action is required, this complaint may be reopened and further investigated.Review of labeling: possible adverse events.Bending, disassembly, or fracture of implant and components.

• Brand Name: VU MESH VBR SYSTEM
• Common Device Name: 12MM SQ CAGE X 15MM LONG
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: audrey mudderman ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 17827002
• Report Number: 3012120772-2023-00028
• Device Sequence Number: 6124953
• Product Code: MQP
• UDI-Device Identifier: 10889981036225
• UDI-Public: 10889981036225
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2023

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: 15-10-1215
• Device Catalogue Number: 15-10-1215
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/27/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown