SUPERION INDIRECT DECOMPRESSION SYSTEM 101-9814

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 2020-02-14 for SUPERION INDIRECT DECOMPRESSION SYSTEM 101-9814 manufactured by Vertiflex Inc..

Event Text Entries

[185259729] Additional suspect medical device components involved in the event: model # 101-9814, serial # (b)(4), description: superion ids 14mm.
Patient Sequence No: 1, Text Type: N, H10


[185259730] A report was received that during a two implant surgery while the physician was malleting the second spacer the lamina broke and the spacer advanced further than the physician would like. Since a break was suspected the physician determined the safest thing to do was to remove both spacers. The patient was able to walk following the procedure. The patient was admitted to the er the night of the procedure for pain control. A ct was taken to determine both lamina and spinous process breakage at l3/4 and l4/5. The patient was discharged from the er after the pain was controlled.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006630150-2020-00572
MDR Report Key9713895
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-17
Date Mfgr Received2020-01-17
Date Added to Maude2020-02-14
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 INDIRECT DECOMPRESSION SYSTEM
Generic NamePROSTHESIS, SPINOUS PROCESS SPACER/PLATE
Product CodeNQO
Date Received2020-02-14
Model Number101-9814
Catalog Number101-9814
Lot Number800149
OperatorLAY USER/PATIENT
Device AvailabilityN
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. Hospitalization; 2. Required No Informationntervention 2020-02-14

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