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 Problem Rash (2033)

Event Date 09/28/2018

Event Type  Injury  

Event Description

It was reported that the patient stated her body was rejecting the titanium of the spacer and she was experiencing a full body rash.

Event Description

It was reported that the patient stated her body was rejecting the titanium of the spacer and she was experiencing a full body rash.

• 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: 10094095
• MDR Text Key: 192651811
• Report Number: 3006630150-2020-02248
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/04/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/29/2022
• Device Model Number: 100-9812
• Device Catalogue Number: 100-9812
• Device Lot Number: 800003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 07/06/2020
• Supplement Dates FDA Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other