MAGEC SPINAL BRACING AND DISTRACTION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM manufactured by Nuvasive Specialized Orthopedics, Inc..

Event Text Entries

[188504279] No product has been returned for evaluation. No lab culture results were provided to confirm the reported event. No root cause can be confirmed at this time.
Patient Sequence No: 1, Text Type: N, H10


[188504280] Information was received that a revision procedure was performed on (b)(6) 2018. As per reporter, the patient developed an infection. It is unknown if the infection was related to the device.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006179046-2020-00163
MDR Report Key9908859
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2018-01-08
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-31
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 Phone6197314188
Manufacturer G1NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Manufacturer Street101 ENTERPRISE SUITE 100
Manufacturer CityALISO VIEJO CA 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 CodePGN
Date Received2020-03-31
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
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 2020-03-31

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