MOBI-C IMPLANT, UNKNOWN SIZE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-12 for MOBI-C IMPLANT, UNKNOWN SIZE manufactured by Ldr Medical.

Event Text Entries

[187557127] Device evaluated by manufacturer: "no information" entered in error. The implant was not returned for evaluation, so no results are available and no conclusions can be drawn. The lot number is unknown; therefore the device history records are unable to be reviewed.
Patient Sequence No: 1, Text Type: N, H10


[187557128] It was reported that a mobi-c implant was removed due to migration / subsidence. There was no further impact to the patient reported and no further event details provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004788213-2020-00009
MDR Report Key9826258
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-12
Date of Report2020-03-12
Date of Event2019-05-08
Date Mfgr Received2019-06-18
Date Added to Maude2020-03-12
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'OUEST 5, RUE DR BERLIN
Manufacturer CitySAINTE-SAVINE, NA 10300
Manufacturer CountryFR
Manufacturer Postal10300
Manufacturer Phone33382803
Manufacturer G1LDR M
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 NameMOBI-C IMPLANT, UNKNOWN SIZE
Generic NameMOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
Product CodeMJO
Date Received2020-03-12
Model NumberNA
Catalog NumberNI
Lot NumberNI
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
101. Hospitalization; 2. Required No Informationntervention 2020-03-12

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