MAZOR X GUIDANCE SYSTEM TPL0059

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 2020-03-23 for MAZOR X GUIDANCE SYSTEM TPL0059 manufactured by Mazor Robotics Ltd.

MAUDE Entry Details

Report Number3005075696-2020-00077
MDR Report Key9869445
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-24
Date Mfgr Received2020-02-24
Device Manufacturer Date2018-10-01
Date Added to Maude2020-03-23
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 ContactSTACY RUEMPING
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635260594
Manufacturer G1MAZOR ROBOTICS LTD
Manufacturer Street5 SHACHAM STREET P.O. BOX 3104
Manufacturer CityCAESAREA HEFA,IL 3079567
Manufacturer CountryIL
Manufacturer Postal Code3079567
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAZOR X GUIDANCE SYSTEM
Generic NameORTHOPEDIC STEREOTAXIC INSTRUMENT
Product CodeOLO
Date Received2020-03-23
Model NumberTPL0059
Catalog NumberTPL0059
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAZOR ROBOTICS LTD
Manufacturer Address5 SHACHAM STREET P.O. BOX 3104 CAESAREA HEFA,IL 3079567 IL 3079567


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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