VIPER PRIME MOD CFXFEN 6X50 186727650 186725650

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 2019-06-07 for VIPER PRIME MOD CFXFEN 6X50 186727650 186725650 manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

Report Number1526439-2019-51737
MDR Report Key8679620
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-06-07
Date of Report2019-05-17
Date Mfgr Received2019-08-29
Device Manufacturer Date2019-02-21
Date Added to Maude2019-06-07
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVIPER PRIME MOD CFXFEN 6X50
Generic NameBONE CEMENT, POSTERIOR SCREW AUGMENTATION
Product CodePML
Date Received2019-06-07
Returned To Mfg2019-08-23
Model Number186727650
Catalog Number186725650
Lot Number232176
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-07

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