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

Model Number 101-9812

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: superion implant.

Event Description

It was reported that the patient experienced ineffective therapy from the implanted devices.The patient underwent an explant procedure in which the two devices were explanted.The current location of the devices is unknown.No other information was provided.

Manufacturer Narrative

Block h6 patient code: 3191: no code available, is used as there is no adequate fda code to describe a surgery.Additional suspect medical device component involved in the event: product family: superion implant.Upn: 101-9812.Model: 101-9812.Serial: not applicable.Batch: 800253.

Event Description

It was reported that the patient underwent an explant procedure due to lack of effective therapy.The patient is doing well post operatively.Additional information was received that the two explanted devices were discarded by the facility.

• 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: 10873591
• MDR Text Key: 217300020
• Report Number: 3006630150-2020-05715
• 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
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 700065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention