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

Model Number 101-9812

Device Problem Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: superion implant; upn: (b)(4), model: 101-9816, serial: null, batch: 800228.Product family: superion implant; upn: (b)(4), model: 101-9812, serial: null, batch: 800244.

Event Description

It was reported that during the superion implant procedure the physician attempted to use 3 different spacers that broke.The physician decided to abort the procedure.The patient was doing fine post operatively.

Event Description

It was reported that during the superion implant procedure the physician attempted to use 3 different spacers that broke.The physician decided to abort the procedure.The patient was doing fine post operatively.

Manufacturer Narrative

Correction to field h6: patient codes.H6 patient code 3191: no code available was used because there is not an equivalent fda code for surgical intervention.

• 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
• MDR Report Key: 10695576
• MDR Text Key: 211873982
• Report Number: 3006630150-2020-04926
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800244
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention