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

Model Number 101-9810

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

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

Event Date 12/11/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had previously been implanted with two devices that provided relief and had a third implant put in place in l5-s1.Post implant, the patient began to experience constant and significant pain in the right flank area.The patient was administered injections in an attempt to alleviate the pain but they did not provide relief.The patient underwent an explant procedure to remove the device located in l5-s1.The explanted device will not be returned as it was retained by the patient.The patient is doing well post-operatively.

Event Description

It was reported that the patient had previously been implanted with two devices that provided relief and had a third implant put in place in l5-s1.Post implant, the patient began to experience constant and significant pain in the right flank area.The patient was administered injections in an attempt to alleviate the pain but they did not provide relief.The patient underwent an explant procedure to remove the device located in l5-s1.The explanted device will not be returned as it was retained by the patient.The patient is 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: 11052951
• MDR Text Key: 223057018
• Report Number: 3006630150-2020-06319
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000536
• UDI-Public: 00884662000536
• 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: 01/19/2021

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: 101-9810
• Device Catalogue Number: 101-9810
• Device Lot Number: 800325
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention