SUPERION INTERSPINOUS SPACER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for SUPERION INTERSPINOUS SPACER manufactured by Vertiflex Inc..

Event Text Entries

[182429718] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-01040
MDR Report Key9801766
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-06
Date of Report2020-04-03
Date of Event2020-02-03
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTALAR TAHMASIAN
Manufacturer Street25155 RYE CANYON LOOP
Manufacturer CityVALENCIA CA 91355
Manufacturer CountryUS
Manufacturer Postal91355
Manufacturer Phone6619494863
Manufacturer G1VERTIFLEX INC.
Manufacturer Street2714 LOKER AVE. WEST
Manufacturer CityCARLSBAD CA 92010
Manufacturer CountryUS
Manufacturer Postal Code92010
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERION INTERSPINOUS SPACER
Generic NamePROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Product CodeNQO
Date Received2020-03-06
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVERTIFLEX INC.
Manufacturer Address2714 LOKER AVE. WEST SUITE 100 CARLSBAD CA


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-06

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