CAVUX CERVICAL CAGE-B 5MM PD-31-201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,study report with the FDA on 2019-10-21 for CAVUX CERVICAL CAGE-B 5MM PD-31-201 manufactured by Providence Medical Technology, Inc..

MAUDE Entry Details

Report Number3009394448-2019-00016
MDR Report Key9216637
Report SourceCOMPANY REPRESENTATIVE,STUDY
Date Received2019-10-21
Date of Report2019-10-15
Date of Event2019-09-23
Date Mfgr Received2019-09-23
Date Added to Maude2019-10-21
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 ContactDR. JANIE MANDRUSOV
Manufacturer Street3875 HOPYARD RD SUITE 300
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal94588
Manufacturer Phone4153013128
Manufacturer G1PROVIDENCE MEDICAL TECHNOLOGY, INC.
Manufacturer Street3875 HOPYARD RD SUITE 300
Manufacturer CityPLEASANTON CA 94588
Manufacturer CountryUS
Manufacturer Postal Code94588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAVUX CERVICAL CAGE-B 5MM
Generic NameINTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
Product CodeODP
Date Received2019-10-21
Model NumberPD-31-201
Catalog NumberPD-31-201
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 94588 US 94588


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-10-21

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