HUMERAL NAIL T2 HUMERUS ?9X200 MM 1830-0920S 18300920S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for HUMERAL NAIL T2 HUMERUS ?9X200 MM 1830-0920S 18300920S manufactured by Stryker Trauma Kiel.

MAUDE Entry Details

Report Number0009610622-2020-00134
MDR Report Key9907827
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-02
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-31
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 ContactMR. KEVIN SMITH
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER TRAUMA KIEL
Manufacturer StreetPROF. KUENTSCHER-STRASSE 1-5
Manufacturer CitySCHOENKIRCHEN/KIEL D-24232
Manufacturer CountryDE
Manufacturer Postal CodeD-24232
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHUMERAL NAIL T2 HUMERUS ?9X200 MM
Generic NameROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Product CodeHSB
Date Received2020-03-31
Model Number1830-0920S
Catalog Number18300920S
Lot NumberK277386RB
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER TRAUMA KIEL
Manufacturer AddressPROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 DE D-24232


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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