CAVUX CERVICAL CAGE-B PD-31-200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for CAVUX CERVICAL CAGE-B PD-31-200 manufactured by Providence Medical Technology, Inc..

MAUDE Entry Details

Report Number3009394448-2020-00002
MDR Report Key9908595
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-30
Date of Event2018-08-14
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. ED LIOU
Manufacturer Street3875 HOPYARD RD SUITE 300
Manufacturer CityPLEASANTON, CA
Manufacturer CountryUS
Manufacturer Phone5213412
Manufacturer G1PROVIDENCE MEDICAL TECHNOLOGY, INC.
Manufacturer Street3875 HOPYARD RD SUITE 300
Manufacturer CityPLEASANTON, CA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAVUX CERVICAL CAGE-B
Generic NameINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Product CodeODP
Date Received2020-03-31
Model NumberPD-31-200
Catalog NumberPD-31-200
Lot Number046116
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPROVIDENCE MEDICAL TECHNOLOGY, INC.
Manufacturer Address3875 HOPYARD RD SUITE 300 PLEASANTON, CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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