KYPHON XPANDER INFLATABLE BONE TAMP K09A

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 2020-03-26 for KYPHON XPANDER INFLATABLE BONE TAMP K09A manufactured by Medtronic Mexico.

MAUDE Entry Details

Report Number9612164-2020-01361
MDR Report Key9882881
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-26
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 G1MEDTRONIC MEXICO
Manufacturer StreetAV. PASEO DEL CUCAPAH #10510
Manufacturer CityTIJUANA,BC 22570
Manufacturer CountryMX
Manufacturer Postal Code22570
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameKYPHON XPANDER INFLATABLE BONE TAMP
Generic NameARTHROSCOPE
Product CodeHRX
Date Received2020-03-26
Model NumberNA
Catalog NumberK09A
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MEXICO
Manufacturer AddressAV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-26

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