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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 Migration (4003)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing back pain a couple of weeks after the implant procedure.It was assessed that the device had migrated posterior at l4-l5.The patient underwent an explant procedure to remove the device.The explanted device will not be returned as it was retained by the facility.The patient status is unknown.
 
Event Description
It was reported that the patient was experiencing back pain a couple of weeks after the implant procedure.It was assessed that the device had migrated posterior at l4-l5.The patient underwent an explant procedure to remove the device.The explanted device will not be returned as it was retained by the facility.The patient status is unknown.Additional information was received that the patient was doing well post-operatively.
 
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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
MDR Report Key11211749
MDR Text Key228159346
Report Number3006630150-2021-00101
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 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number700081
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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