KYPHX HV-R BONE CEMENT C01A-J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-05 for KYPHX HV-R BONE CEMENT C01A-J manufactured by Mdt Kyphon Neuchatel Mfg.

MAUDE Entry Details

Report Number2953769-2020-00005
MDR Report Key9796121
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-06
Date Mfgr Received2020-02-06
Date Added to Maude2020-03-05
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 ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MDT KYPHON NEUCHATEL MFG
Manufacturer StreetPIERRE-
Manufacturer CityNEUCH 2000
Manufacturer CountryCH
Manufacturer Postal Code2000
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKYPHX HV-R BONE CEMENT
Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-03-05
Model NumberNA
Catalog NumberC01A-J
Lot NumberEL70122
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMDT KYPHON NEUCHATEL MFG
Manufacturer AddressPIERRE-?-BOT 97 NEUCH?TEL 2000 CH 2000


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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