MAGEC SPINAL BRACING AND DISTRACTION SYSTEM MC2-4570S

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 2020-03-31 for MAGEC SPINAL BRACING AND DISTRACTION SYSTEM MC2-4570S manufactured by Nuvasive Specialized Orthopedics, Inc..

Event Text Entries

[188504138] No product has been returned for evaluation nor were lab culture results provided to confirm the alleged event. No indication of product malfunction was identified. Based on the information provided root cause could not be identified.
Patient Sequence No: 1, Text Type: N, H10


[188504139] Information was received that a revision procedure was performed on (b)(6) 2020. As per the reporter, the patient developed an infection and the surgeon decided to remove the rod. There was no alleged device malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006179046-2020-00161
MDR Report Key9908668
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-06
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-08-21
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
Model NumberMC2-4570S
Lot Number9082102
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; 2. Other 2020-03-31

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