GRAFTON DBM T43105JPN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-06 for GRAFTON DBM T43105JPN manufactured by Medtronic Eatontown.

MAUDE Entry Details

Report Number2246640-2019-00006
MDR Report Key8765786
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-06
Date of Report2019-07-06
Date of Event2019-06-06
Date Mfgr Received2019-06-07
Date Added to Maude2019-07-06
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC EATONTOWN
Manufacturer Street201 INDUSTRIAL WAY WEST
Manufacturer CityEATONTOWN NJ 07724
Manufacturer CountryUS
Manufacturer Postal Code07724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRAFTON DBM
Generic NameBONE GRAFTING MATERIAL, HUMAN SOURCE
Product CodeNUN
Date Received2019-07-06
Model NumberNA
Catalog NumberT43105JPN
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC EATONTOWN
Manufacturer Address201 INDUSTRIAL WAY WEST EATONTOWN NJ 07724 US 07724


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2019-07-06

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.