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 05/22/2020

Event Type  Injury  

Manufacturer Narrative

The explanted devices will not be returned as they were discarded by the medical facility.Additional suspect medical devices involved: model: no information, lot #: no information, description: no information.

Event Description

It was reported that a patient did not receive the expected relief from the implants and wanted them removed.The devices were explanted without any complications.

Manufacturer Narrative

The explanted devices will not be returned as they were discarded by the medical facility.Additional suspect medical devices involved: model: 101-9812; lot#: 800095; description: superion ids 12mm.

Event Description

It was reported that a patient did not receive the expected relief from the implants and wanted them removed.The devices were explanted without any complications.

• 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: 10145825
• MDR Text Key: 194924298
• Report Number: 3006630150-2020-02445
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/09/2023
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention