CAMBRIA NM 39-2609-S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-04-10 for CAMBRIA NM 39-2609-S manufactured by Seaspine Inc..

MAUDE Entry Details

Report Number3012120772-2019-00011
MDR Report Key8501607
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-04-10
Date of Report2019-04-10
Date of Event2019-03-14
Date Mfgr Received2019-03-15
Date Added to Maude2019-04-10
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 ContactAARON
Manufacturer Street5770 ARMADA DRIVE
Manufacturer CityCA 92008
Manufacturer CountryUS
Manufacturer Postal92008
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCAMBRIA NM
Generic NameIMPLANT, FIXATION DEVICE, SPINAL
Product CodeJDN
Date Received2019-04-10
Returned To Mfg2019-04-02
Model Number39-2609-S
Lot NumberAU19547605D
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSEASPINE INC.
Manufacturer Address5770 ARMADA DRIVE CALSBAD CA 92008 US 92008


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-10

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