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

Model Number 101-9814

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

Patient Problems Pain (1994); Seroma (2069); Impaired Healing (2378); Fluid Discharge (2686)

Event Date 02/10/2020

Event Type  Injury  

Event Description

A report was received that during a follow up appointment the physician noticed poor healing of the incision site.The patient was experiencing redness, drainage at the incision site and increased back pain.An mri revealed a seroma at the incision site.The physician believed it was a localized skin infection and it did not believe the event was procedure related.The patient was given antibiotic and referred to a wound clinic.

Event Description

A report was received that during a follow up appointment the physician noticed poor healing of the incision site.The patient was experiencing redness, drainage at the incision site and increased back pain.An mri revealed a seroma at the incision site.The physician believed it was a localized skin infection and it did not believe the event was procedure related.The patient was given antibiotic and referred to a wound clinic.

• 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: 9820923
• MDR Text Key: 183125097
• Report Number: 3006630150-2020-01135
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• 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: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 700041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention