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

Model Number 102-9800

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure to reposition the superion implant in which the physician assessed was more posterior than he would like.During the revision procedure the physician was unable to remove the implant after it was undeployed as it was stuck in the space.The physician determined the best solution would be to tap the implant down so that it was no longer posterior and closer to the lamina.The patient was doing well post operatively.

• 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; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 10555755
• MDR Text Key: 207606118
• Report Number: 3006630150-2020-04316
• 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: 09/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 102-9800
• Device Catalogue Number: 102-9800
• Device Lot Number: 203925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/18/2020
• 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): Required Intervention