5.5 EXP VERSE FEN SCR 7.0X45 199723745

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 2020-03-16 for 5.5 EXP VERSE FEN SCR 7.0X45 199723745 manufactured by Medos International Sàrl Ch.

MAUDE Entry Details

Report Number1526439-2020-00722
MDR Report Key9836412
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-16
Date of Report2020-02-18
Date Mfgr Received2020-02-18
Date Added to Maude2020-03-16
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 7.0X45
Generic NameORTHOSIS, SPINAL PEDICLE FIXATION
Product CodeMNI
Date Received2020-03-16
Returned To Mfg2020-03-11
Model Number199723745
Catalog Number199723745
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDOS INTERNATIONAL SàRL CH
Manufacturer AddressCHEMIN-BLANC 38 LE LOCLE 02400 SZ 02400


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-16

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