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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 06/16/2020
Event Type  Injury  
Event Description
It was reported that the spacer was explanted due to her pain getting worse after the spacer was implanted.The explanted spacer was kept by the medical facility.
 
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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 92010
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 Key10286666
MDR Text Key199231662
Report Number3006630150-2020-02960
Device Sequence Number1
Product Code NQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number101-9810
Device Catalogue Number101-9810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/16/2020
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 Number1
Patient Outcome(s) Required Intervention;
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