IMPLANT ROI-C 12X14 H4,5 MC1340P

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 IMPLANT ROI-C 12X14 H4,5 MC1340P manufactured by Ldr Medical.

MAUDE Entry Details

Report Number3004788213-2019-00312
MDR Report Key9322574
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-14
Date of Report2019-11-14
Date of Event2019-09-27
Date Mfgr Received2019-10-15
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 ContactMS. FLORENCE MAILY
Manufacturer StreetQUARTIER EUROPE DE L 5, RUE DE BERLIN
Manufacturer CitySAINTE-SAVINE, NA 10300
Manufacturer CountryFR
Manufacturer Postal10300
Manufacturer Phone33382803
Manufacturer G1LDR MEDICAL
Manufacturer StreetQUARTIER EUROPE DE L 5, RUE DE BERLIN
Manufacturer CitySAINTE-SAVINE, NA 10300
Manufacturer CountryFR
Manufacturer Postal Code10300
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameIMPLANT ROI-C 12X14 H4,5
Generic NameLDR SPINE CERVICAL INTERBODY FUSION SYSTEM
Product CodeODP
Date Received2019-11-14
Model NumberNA
Catalog NumberMC1340P
Lot Number54016C105
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLDR MEDICAL
Manufacturer AddressQUARTIER EUROPE DE L?OUEST 5, RUE DE BERLIN SAINTE-SAVINE, NA 10300 FR 10300


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-14

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