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

Model Number 140-9800

Device Problem Failure to Disconnect (2541)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 04/01/2022

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 290141439
• Report Number: 3006630150-2022-01866
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: American Indian Or Alaskan Native