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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERTIFLEX INC. SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
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VERTIFLEX INC. SUPERION INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Fluid Discharge (2686)
Event Date 02/03/2020
Event Type  Injury  
Event Description
A report was received that there was drainage at the spacer implant site.The physician diagnosed it as a superficial skin infection.The patient was put on a 7 day course of antibiotics.
 
Event Description
A report was received that there was drainage at the spacer implant site.The physician diagnosed it as a superficial skin infection.The patient was put on a 7 day course of antibiotics.
 
Manufacturer Narrative
Additional information was received that the physician confirmed it to be a superficial skin infection and not a deep infection involving the implanted device.The physician did not report any contributory operative factors and nothing happened in the procedure to increase the risk of infection.The patient was reportedly doing well.
 
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Brand Name
SUPERION INTERSPINOUS SPACER
Type of Device
PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Manufacturer (Section D)
VERTIFLEX INC.
2714 loker ave. west
suite 100
carlsbad CA
MDR Report Key9801766
MDR Text Key182429718
Report Number3006630150-2020-01040
Device Sequence Number1
Product Code NQO
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 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/07/2020
Initial Date FDA Received03/06/2020
Supplement Dates Manufacturer Received03/06/2020
Supplement Dates FDA Received04/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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