MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-5555SL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-09-03 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM RA002-5555SL manufactured by Nuvasive Specialized Orthopedics, Inc.

MAUDE Entry Details

Report Number3006179046-2019-00151
MDR Report Key8956962
Report SourceFOREIGN
Date Received2019-09-03
Date of Report2019-11-20
Date Mfgr Received2019-11-20
Device Manufacturer Date2015-12-11
Date Added to Maude2019-09-03
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. TIARA RAE
Manufacturer Street101 ENTERPRISE, SUITE 100
Manufacturer CityALISO VIEJO CA 92656
Manufacturer CountryUS
Manufacturer Postal92656
Manufacturer Phone8583204589
Manufacturer G1NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Manufacturer Street101 ENTERPRISE, SUITE 100
Manufacturer CityALISO VIEJO 92656
Manufacturer CountryUS
Manufacturer Postal Code92656
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAGEC SPINAL BRACING AND DISTRACTION SYSTEM
Generic NameGROWING ROD SYSTEM-MAGNETIC ACTUATION
Product CodePNG
Date Received2019-09-03
Model NumberRA002-5555SL
Lot Number1112158-010
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNUVASIVE SPECIALIZED ORTHOPEDICS, INC
Manufacturer Address101 ENTERPRISE, SUITE 100 ALISO VIEJO CA 92656 US 92656


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-09-03

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