MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9812

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

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 11/09/2020

Event Type  Injury  

Event Description

It was reported that the patient was experiencing discomfort.A ct scan was taken and no abnormalities were revealed.A revision procedure was performed in which the physician implanted a different size device.The explanted device will not be returned as it was retained by the facility.The patient is doing well post-operatively.

Manufacturer Narrative

H6 3191: no code available was used as there is no equivalent fda code for surgery.H6 evaluation method codes (2) - evaluation of production records 3331; device not returned 4114.H6 evaluation result codes (2 - no findings available 3221; no device problem found 213.H6 evaluation conclusion codes (1) - known inherent risk of device 22.

Event Description

It was reported that the patient was experiencing discomfort.A ct scan was taken and no abnormalities were revealed.A revision procedure was performed in which the physician implanted a different size device.The explanted device will not be returned as it was retained by the facility.The patient is doing well post-operatively.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• 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: 10971800
• MDR Text Key: 220402120
• Report Number: 3006630150-2020-06076
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: 01/08/2021

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 Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 800255
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/15/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention