2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING 45-20001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for 2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING 45-20001 manufactured by Stryker Gmbh.

MAUDE Entry Details

Report Number0008031020-2020-00881
MDR Report Key9891716
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-02-11
Date Mfgr Received2020-03-03
Device Manufacturer Date2014-09-03
Date Added to Maude2020-03-27
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. SHARON RIVAS
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1STRYKER LEIBINGER FREIBURG
Manufacturer StreetBOETZINGERSTR. 41
Manufacturer CityFREIBURG D-79111
Manufacturer CountryDE
Manufacturer Postal CodeD-79111
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2.0MM ASNIS MICRO, CANNULATED SCREWDRIVER, 2.0MM, AO COUPLING
Generic NameORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Product CodeLXH
Date Received2020-03-27
Returned To Mfg2020-02-17
Model Number45-20001
Catalog Number45-20001
Lot NumberAE11
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER GMBH
Manufacturer AddressBOHNACKERWEG 1 POSTFACH SELZACH 2545 CH 2545


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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