RESTORE FULLFLUTE REAM 12MM *EA 219342

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 2019-11-26 for RESTORE FULLFLUTE REAM 12MM *EA 219342 manufactured by Depuy Mitek Llc Us.

MAUDE Entry Details

Report Number1221934-2019-59786
MDR Report Key9375493
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-26
Date of Report2019-10-31
Date of Event2019-10-31
Date Mfgr Received2019-10-31
Date Added to Maude2019-11-26
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6013142063
Manufacturer G1DEPUY MITEK LLC US
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 NameRESTORE FULLFLUTE REAM 12MM *EA
Generic NameCANNULATED SURGICAL DRILL
Product CodeHTD
Date Received2019-11-26
Catalog Number219342
Lot Number1601001
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerDEPUY MITEK LLC US
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-26

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