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 Unspecified Infection (1930); Complaint, Ill-Defined (2331); Fluid Discharge (2686); No Code Available (3191); Insufficient Information (4580)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional suspect medical device component involved in the event: product family: superion implant, upn: (b)(4), model: 101-9810, serial: n/a, batch: 800306.

Event Description

It was reported that the patient developed a seroma after an implant procedure.The patient was monitored and treated with antibiotics.The patient was later hospitalized for hip issues and her back began leaking purulent fluid.A culture was performed and it tested positive for an infection.The patient was treated with antibiotics and then underwent an explant procedure to remove both spacers.No products will be returned per facility policy.

Event Description

It was reported that the patient developed a seroma after an implant procedure.The patient was monitored and treated with antibiotics.The patient was later hospitalized for hip issues and her back began leaking purulent fluid.A culture was performed and it tested positive for an infection.The patient was treated with antibiotics and then underwent an explant procedure to remove both spacers.No products will be returned per facility policy.Additional information was received that the patient is healing and slowing improving.

• 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: 11181199
• MDR Text Key: 227529232
• Report Number: 3006630150-2020-06696
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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: 800322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention