THORACOLUMBOSACRAL PEDICAL SCREW SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-27 for THORACOLUMBOSACRAL PEDICAL SCREW SYSTEM manufactured by Nuvasive, Incorporated.

MAUDE Entry Details

Report Number2031966-2020-00066
MDR Report Key9887232
Report SourceCONSUMER,OTHER
Date Received2020-03-27
Date of Report2020-03-26
Date of Event2017-06-17
Date Mfgr Received2020-03-25
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMRS. YOBANA SANCHEZ
Manufacturer Street7475 LUSK BLVD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer G1NUVASIVE, INCORPORATED
Manufacturer Street7475 LUSK BLVD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameTHORACOLUMBOSACRAL PEDICAL SCREW SYSTEM
Product CodeNKB
Date Received2020-03-27
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNUVASIVE, INCORPORATED
Manufacturer Address7475 LUSK BLVD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-27

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