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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 Problems Difficult to Open or Close (2921); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2020
Event Type  malfunction  
Event Description
It was reported that during the procedure the spacer seemed to be caught on the inferior lamina.The physician attempted to continue with the implant but the spacer would not open completely.However, the physician released the spacer into the patient.It was noted that the cap of the spacer came out with the implanting tools.The physician was able to remove the screw from the spacer which allowed the spacer to close and be removed from the patient.The procedure was aborted without a spacer being implanted.The patient was sent to a neurosurgeon for consult.
 
Manufacturer Narrative
Analysis of the 10mm implant lot number 700060 confirmed the implant had clearly suffered significant damage.The spindle cap was completely sheared off from the implant body.The damage was sufficient to preclude functional testing.The damage to implant indicated failure likely due to a combination of deployment against resistance and the physician failing to correctly attach the inserter to the spacer.
 
Event Description
It was reported that during the procedure the spacer seemed to be caught on the inferior lamina.The physician attempted to continue with the implant but the spacer would not open completely.However, the physician released the spacer into the patient.It was noted that the cap of the spacer came out with the implanting tools.The physician was able to remove the screw from the spacer which allowed the spacer to close and be removed from the patient.The procedure was aborted without a spacer being implanted.The patient was sent to a neurosurgeon for consult.
 
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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 Key10168047
MDR Text Key195570450
Report Number3006630150-2020-02518
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 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9810
Device Catalogue Number101-9810
Device Lot Number700060
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2020
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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