PINN CAN BONE SCREW 6.5MMX25MM 121725500

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 2019-08-26 for PINN CAN BONE SCREW 6.5MMX25MM 121725500 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2019-102187
MDR Report Key8931826
Report SourceOTHER
Date Received2019-08-26
Date of Report2015-10-12
Date of Event2015-08-28
Date Mfgr Received2019-08-05
Device Manufacturer Date2010-02-16
Date Added to Maude2019-08-26
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 Street700 ORTHOPAEDIC DRIVE
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal465810988
Manufacturer Phone6107428552
Manufacturer G1DEPUY INT'L LTD. 8010379
Manufacturer StreetST. ANTHONY'S RD
Manufacturer CityLEEDS LS118 DT
Manufacturer CountryUK
Manufacturer Postal CodeLS11 8 DT
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePINN CAN BONE SCREW 6.5MMX25MM
Generic NameBONE SCREWS AND PINS : SCREWS
Product CodeNDJ
Date Received2019-08-26
Catalog Number121725500
Lot Number419768
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-08-26

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