AFFIX

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 2019-08-14 for AFFIX manufactured by Nuvasive.

MAUDE Entry Details

Report Number2031966-2019-00226
MDR Report Key8893746
Report SourceCONSUMER,OTHER
Date Received2019-08-14
Date of Report2019-07-19
Date of Event2015-07-21
Date Mfgr Received2019-07-17
Date Added to Maude2019-08-14
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. YOBANA SANCHEZ
Manufacturer Street7475 LUSK BOULEVARD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8589093383
Manufacturer G1NUVASIVE
Manufacturer Street7475 LUSK BOULEVARD
Manufacturer CitySAN DIEGO 92121
Manufacturer CountryUS
Manufacturer Postal Code92121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFFIX
Generic NameSPINAL INTERLAMINAL FIXATION ORTHOSIS
Product CodePEK
Date Received2019-08-14
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNUVASIVE
Manufacturer Address7475 LUSK BOULEVARD SAN DIEGO 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-14

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