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

Model Number	140-9800
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the during a superion indirect decompression spacer implant procedure, the device malfunctioned and the dilator advanced too far anterior.The patient experienced a dura injury at l4-l5 of the lumbar vertebrae and had a cerebrospinal fluid (csf) leak.The physician administered a blood patch and the implant procedure was completed successfully.The patient is doing well post operatively.
Event or Problem Description
It was reported that the during a superion indirect decompression spacer implant procedure, the device malfunctioned and the dilator advanced too far anterior.The patient experienced a dura injury at l4-l5 of the lumbar vertebrae and had a cerebrospinal fluid (csf) leak.The physician administered a blood patch and the implant procedure was completed successfully.The patient is doing well post operatively.
Additional Manufacturer Narrative
The complaint was confirmed.The cannula assembly could not be inserted over the dilator due to the presence of metallic protrusions on the inner surface area of the dilator 2.A welding process that was performed in error resulted in a weld intrusion.In addition, the reported allegation of a csf leak is a known inherent risk 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14216655
• Report Number: 3006630150-2022-01866
• Device Sequence Number: 5359226
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 28501597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: American Indian Or Alaskan Native