VG2 CERVICAL RASP STAND 5X7 273340107

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-10-25 for VG2 CERVICAL RASP STAND 5X7 273340107 manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2019-52298
MDR Report Key9240796
Report SourceOTHER
Date Received2019-10-25
Date of Report2019-09-30
Date Mfgr Received2019-11-05
Date Added to Maude2019-10-25
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1DEPUY SPINE INC
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal Code02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVG2 CERVICAL RASP STAND 5X7
Generic NameRASP, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGAC
Date Received2019-10-25
Returned To Mfg2019-10-03
Catalog Number273340107
Lot NumberBW0803
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-25

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