SIG HP RP TIBIA INSERT CASE 950502807

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 2019-10-31 for SIG HP RP TIBIA INSERT CASE 950502807 manufactured by Depuy Orthopaedics Inc Us.

MAUDE Entry Details

Report Number1818910-2019-113349
MDR Report Key9260772
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-10-31
Date of Report2019-10-07
Date of Event2019-10-07
Date Mfgr Received2019-11-15
Device Manufacturer Date2008-06-18
Date Added to Maude2019-10-31
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 ContactMRS. KARA DITTY-BOVARD
Manufacturer Street1210 WARD AVENUE
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6107428552
Manufacturer G1DEPUY ORTHOPAEDICS, INC. 1818910
Manufacturer Street700 ORTHOPAEDIC DR.
Manufacturer CityWARSAW IN 465810988
Manufacturer CountryUS
Manufacturer Postal Code465810988
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSIG HP RP TIBIA INSERT CASE
Generic NameKNEE INSTRUMENT : INSTRUMENT CASES
Product CodeFSM
Date Received2019-10-31
Returned To Mfg2019-11-14
Catalog Number950502807
Lot NumberB42AR4
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY ORTHOPAEDICS INC US
Manufacturer Address700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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