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 11/09/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a successful explant procedure due to inadequate pain relief.

Event Description

It was reported that the patient underwent a successful explant procedure due to inadequate pain relief.

Manufacturer Narrative

Box h6 3191 no code available was used as there is no equivalent fda code for surgical intervention.Additional suspect medical device components involved in the event product family: superion instruments, upn: 102-9800, model: 102-9800, lot: 203925, and batch: 203925.

• 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: 10954154
• MDR Text Key: 219848868
• Report Number: 3006630150-2020-06029
• 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: 12/23/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention