IQ MEDIALIZED TIBIA CUTTING GUIDE LEFT NS406R

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 2019-10-24 for IQ MEDIALIZED TIBIA CUTTING GUIDE LEFT NS406R manufactured by Aesculap Ag.

MAUDE Entry Details

Report Number9610612-2019-00727
MDR Report Key9234916
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-24
Date of Report2019-10-24
Date Mfgr Received2019-09-24
Device Manufacturer Date2019-04-18
Date Added to Maude2019-10-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS KERSTIN ROTHWEILER
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal78501
Manufacturer G1AESCULAP AG
Manufacturer StreetPO BOX 40
Manufacturer CityTUTTLINGEN, 78501
Manufacturer CountryGM
Manufacturer Postal Code78501
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIQ MEDIALIZED TIBIA CUTTING GUIDE LEFT
Generic NameKNEE ENDOPROSTHETICS
Product CodeHTZ
Date Received2019-10-24
Returned To Mfg2019-09-27
Model NumberNS406R
Catalog NumberNS406R
Lot Number52516441
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerAESCULAP AG
Manufacturer AddressPO BOX 40 TUTTLINGEN, 78501 GM 78501


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.