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

Model Number 140-9800

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/15/2020

Event Type  Injury  

Event Description

It was reported that the patient's procedure was aborted due to low oxygen levels.The patient was treated by medical staff and transported to the hospital.It is expected for the patient to fully recover.

Event Description

It was reported that the patient's procedure was aborted due to low oxygen levels.The patient was treated by medical staff and transported to the hospital.It is expected for the patient to fully recover.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• 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: 10399009
• MDR Text Key: 202674319
• Report Number: 3006630150-2020-03395
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 193834
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention