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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 101-9812
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2020
Event Type  malfunction  
Event Description
It was reported that during an implant procedure the physician first placed an implant at l3-4, but when tapping down to place a second implant at l4-5 it caused a shift in the implant at l3-4.Doctor decided to remove both implants, and placed a new implant at l3-4 in the correct the position.After replacing the implant at l3-4, the physician opted not to continue the procedure and not to reattempt placement at l4-5.Additional information regarding the patient status to date has not been obtained.The device has been disposed of and will not be returned for analysis.
 
Manufacturer Narrative
Correction to e1 initial report phone: (b)(6).
 
Event Description
It was reported that during an implant procedure the physician first placed an implant at l3-4, but when tapping down to place a second implant at l4-5 it caused a shift in the implant at l3-4.Doctor decided to remove both implants, and placed a new implant at l3-4 in the correct the position.After replacing the implant at l3-4, the physician opted not to continue the procedure and not to reattempt placement at l4-5.Additional information regarding the patient status to date has not been obtained.The device has been disposed of and will not be returned for analysis.Additional information received that the patient had normal recovery time.
 
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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 Key10684404
MDR Text Key211502597
Report Number3006630150-2020-04892
Device Sequence Number1
Product Code NQO
UDI-Device Identifier00884662000543
UDI-Public00884662000543
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 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101-9812
Device Catalogue Number101-9812
Device Lot Number700084
Was Device Available for Evaluation? No
Date Manufacturer Received10/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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