ROI-C SHORT ANCHORING PLATE MC1005T

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-09 for ROI-C SHORT ANCHORING PLATE MC1005T manufactured by Ldr Medical.

Event Text Entries

[179250734] Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10


[179250735] It was reported that during the procedure, the plate was not able to be fully installed into the cage during impaction. The cage and plate was removed and an alternate implant was used to complete the case. There were no reported patient impacts.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004788213-2020-00003
MDR Report Key9571656
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-09
Date of Report2020-01-09
Date of Event2019-12-05
Date Mfgr Received2019-12-12
Date Added to Maude2020-01-09
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 NameROI-C SHORT ANCHORING PLATE
Generic NameROI-C TITANIUM-COATED IMPLANT SYSTEM
Product CodeOVE
Date Received2020-01-09
Model NumberNA
Catalog NumberMC1005T
Lot Number285617/14
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 2020-01-09

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