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

Model Number 102-9800

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model: 140-9800, serial/lot: (b)(4), description: vertiflex instrument platform.

Event Description

It was reported that the patient had trouble breathing during the implant procedure in the middle of the dilation process.The procedure was aborted prior to implantation and the product was discarded.The patient fully recovered after the aborted procedure.

• Brand Name: SUPERION IDS KIT
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): VERTIFLEX INC.; 2714 loker ave. west; suite 100; carlsbad CA
• Manufacturer (Section G): VERTIFLEX INC.; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10518734
• MDR Text Key: 206487548
• Report Number: 3006630150-2020-04121
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000574
• UDI-Public: 00884662000574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 203981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other