MOBI-C P&F IMPLANT 17X19 H5 MB2795

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2020-03-17 for MOBI-C P&F IMPLANT 17X19 H5 MB2795 manufactured by Ldr M?dical.

Event Text Entries

[187557258] This device is not cleared for use within the us; however it is similar to a device that is cleared for use within the us. Common device name: this is similar to mobi-c cervical disc prosthesis. Pma/510(k) number: this is similar to p110009. The explanted device was returned to the manufacturer. However, a full evaluation was unable to be performed since the necessary decontamination records were not provided. The provided x-ray shows the inferior plate has migrated, and the core has also likely migrated. A visual inspection of the device did not identify any obvious indications of damage or malfunction. The cause cannot be determined with the available information. A review if the manufacturing records did not identify any issues that would have contributed to this event. The device's labeling provides instructions on proper site preparation and device installation.
Patient Sequence No: 1, Text Type: N, H10


[187557259] It was reported that a revision surgery was performed to remove a mobi-c device at c5/6 that had been implanted for about 2 months because of device migration that was causing left arm pain and weakness. A competitor's product was installed during the revision surgery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004788213-2020-00036
MDR Report Key9845910
Report SourceDISTRIBUTOR,FOREIGN,HEALTH PR
Date Received2020-03-17
Date of Report2020-03-17
Date of Event2019-01-22
Date Mfgr Received2019-01-28
Device Manufacturer Date2018-07-06
Date Added to Maude2020-03-17
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 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 P&F IMPLANT 17X19 H5
Generic NameSEE H10
Product CodeMJO
Date Received2020-03-17
Returned To Mfg2019-03-12
Model NumberNA
Catalog NumberMB2795
Lot NumberL082056
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerLDR M?DICAL
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 2020-03-17

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