MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9808

Device Problems Defective Device (2588); Migration (4003)

Patient Problems Pain (1994); Discomfort (2330); No Code Available (3191)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient was experiencing pain.X-ray was performed and showed lateral displacement of the device.The physician explanted the spinous process spacer and the patient was doing well post-operatively.

Event Description

It was reported that the patient was experiencing pain.X-ray was performed and showed lateral displacement of the device.The physician explanted the spinous process spacer and the patient was doing well post-operatively.

Manufacturer Narrative

Investigation summary: with the available information, boston scientific concludes that the complaint was confirmed.Device technical analysis: visual examination revealed abrasion on the spindle.The implant functioned acceptably upon functional testing.This damaged is most likely occurred during the explant procedure.Labeling review: a product labeling review identified that the spacer was used per the directions for use.Investigation conclusion: based on the provided information, the investigation conclusion is that the probable cause for the complaint of pain and migration is a known inherent risk of the device.The probable cause for the spindle abrasion is unintended use error cause or contributed to the event.

Manufacturer Narrative

Block h6 patient code; 3191: no code available was used as there is no equivalent fda code for surgical intervention.

Event Description

It was reported that the patient was experiencing pain.X-ray was performed and showed lateral displacement of the device.The physician explanted the spinous process spacer and the patient was doing well post-operatively.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA 92010
• MDR Report Key: 10993141
• MDR Text Key: 220967268
• Report Number: 3006630150-2020-06157
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/02/2024
• Device Model Number: 101-9808
• Device Catalogue Number: 101-9808
• Device Lot Number: 800123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention