MODULAR BOX OSTEOTOME 259807530

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-06 for MODULAR BOX OSTEOTOME 259807530 manufactured by Depuy Orthopaedics, Inc. 1818910.

MAUDE Entry Details

Report Number1818910-2019-100142
MDR Report Key8864232
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-08-06
Date of Report2019-07-17
Date of Event2019-07-17
Date Mfgr Received2019-09-12
Device Manufacturer Date2010-07-15
Date Added to Maude2019-08-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER IN 193800988
Manufacturer CountryUS
Manufacturer Postal193800988
Manufacturer Phone6103142063
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465820988
Manufacturer CountryUS
Manufacturer Postal Code465820988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMODULAR BOX OSTEOTOME
Generic NameHIP INSTRUMENTS : CUTTING INSTRUMENTS
Product CodeHWM
Date Received2019-08-06
Returned To Mfg2019-07-24
Catalog Number259807530
Lot NumberPG0710
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-06

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