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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Model Number 101-9810
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)
Event Date 10/23/2020
Event Type  Injury  
Event Description
It was reported that the patient was not getting pain relief.The patient underwent an explant procedure of the vertiflex superion implant.No further information regarding patient status has been obtained despite good faith efforts.The patient kept the implant and will not be returned for analysis.
 
Event Description
It was reported that the patient was not getting pain relief.The patient underwent an explant procedure of the vertiflex superion implant.No further information regarding patient status has been obtained despite good faith efforts.The patient kept the implant and will not be returned for analysis.Additional information was received that post operatively, the patient's incision was fine.Additionally, the patient reports that post procedure the pain did not go away.
 
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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
MDR Report Key10869209
MDR Text Key217145793
Report Number3006630150-2020-05689
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000536
UDI-Public00884662000536
Combination Product (y/n)N
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date02/27/2024
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number793217
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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