MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION VERTIFLEX INSTRUMENT PLATFORM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number	140-9800
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This product was returned to the manufacturer without any report of performance issues or adverse patient effects.The returned devices were analyzed and visual inspection revealed that interior sterile packaging was damaged.However, the instruments within the kit were subjected to a visual and functional examination, and no anomalies or defects could be confirmed.Therefore, the probable cause selected is cause traced to transport/storage.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, sterility can only be assured if the package is intact.Do not use this device if the package has been opened or damaged.Once opened, do not attempt to reuse or resterilize this product.Store in a suitable, clean area until ready for use.Use sterile packaged superion ids instruments prior to the expiration date listed on the package" as well as "inspect sterile packaged superion ids instruments and packaging to verify that no damage has occurred as a result of shipping and handling.Damage to devices or packaging may indicate the presence of unsafe product.In the event of damage to the sterile packaging, retain the package with the contents and contact boston scientific neuromodulation corporation for replacement" finally "superion ids instruments should be stored in a suitable, clean area prior to use" is noted within the ifu as a potential complication associated with the use of the device.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 25069019
• Report Number: 3006630150-2026-02862
• Device Sequence Number: 10714886
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: (01)00884662000611(17)290702(10)40209188
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2026

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: Other
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 40209188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown