MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION/ VERTIFLEX (R), INCORPORATED VERTIFLEX; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 101-9812

Device Problems Crack (1135); Retraction Problem (1536); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2020

Event Type  malfunction  

Event Description

Pt undergoing superior indirect decompression device placement at l3-l4.During deployment of the device, the tip of the spacer was disconnected from the screwdriver and was found to have cracked at its base.This was then removed.A 10mm superion device was introduced and deployed at the correct depth and then advanced down towards the lamina.Unfortunately, the screwdriver was again sheared off and the spacer became stuck.An attempt to remove the spacer was met with resistance and despite multiple attempts, it remained in place.At that point, the decision to hammer the spacer into the correct position.Ap and lateral images were taken to confirm proper placement of the device.Fda safety report id# (b)(4).

• Brand Name: VERTIFLEX
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION/ VERTIFLEX (R), INCORPORATED
• MDR Report Key: 10239177
• MDR Text Key: 197938419
• Report Number: MW5095380
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 101-9812
• Device Lot Number: 700069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR