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

Model Number	140-9800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model # 140-9800, lot # 193804, description: vertiflex instrument platform - cannula assembly.
Event or Problem Description
It was reported that an implant procedure was aborted due to the patient going into cardiac arrest.While the patient was under anesthesia the incision had been made and the dilator 1 and cannula assembly from the same kit were inserted.The anesthesiologist suggested that the procedure be stopped because the patient's rhythms were not correct then the patient went into cardiac arrest.The procedure was aborted and the patient was taken to the er.The patient is now reportedly doing well.The product will not be returned.

• Brand Name: VERTIFLEX INSTRUMENT PLATFORM
• Common Device Name: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA
• MDR Report Key: 9913203
• Report Number: 3006630150-2020-01587
• Device Sequence Number: 19665498
• Product Code: NQO
• UDI-Device Identifier: 00884662000611
• UDI-Public: 00884662000611
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P140004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2024
• Device Model Number: 140-9800
• Device Catalogue Number: 140-9800
• Device Lot Number: 193804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other