5.5 EXP VERSE FEN SCR 4.35X40 199723440 199723440S

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 2019-11-14 for 5.5 EXP VERSE FEN SCR 4.35X40 199723440 199723440S manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

Report Number1526439-2019-52428
MDR Report Key9321119
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-14
Date of Report2019-09-02
Date Mfgr Received2019-11-25
Device Manufacturer Date2016-08-18
Date Added to Maude2019-11-14
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 StreetCHEMIN-BLANC 38
Manufacturer CityLE LOCLE 02400
Manufacturer CountrySZ
Manufacturer Postal02400
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 Name5.5 EXP VERSE FEN SCR 4.35X40
Generic NameBONE CEMENT, POSTERIOR SCREW AUGMENTATION
Product CodePML
Date Received2019-11-14
Returned To Mfg2019-10-16
Model Number199723440
Catalog Number199723440S
Lot NumberAVKBOG
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 2019-11-14

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