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

Model Number 100-9812

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

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 04/19/2019

Event Type  Injury  

Event Description

It was reported that during the implant procedure the clinical patient, (b)(6) study, experienced a life threatening desaturation.The patient was turned and intubated.The physician decided not to proceed with the l4-5 placement of the device.The patient was successfully implanted at the l3-4 region and is satisfied with the results and has had no complications.

Event Description

It was reported that during the implant procedure the clinical patient, a4086 press study, experienced a life threatening desaturation.The patient was turned and intubated.The physician decided not to proceed with the l4-5 placement of the device.The patient was successfully implanted at the l3-4 region and is satisfied with the results and has had no complications.

• Brand Name: SUPERION INTERSPINOUS SPACER
• 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: 10427992
• MDR Text Key: 203642244
• Report Number: 3006630150-2020-03514
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 100-9812
• Device Catalogue Number: 100-9812
• Device Lot Number: 800089
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 82 YR