NUVASIVE HELIX REVOLUTION ACP SYSTEM

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 2020-03-24 for NUVASIVE HELIX REVOLUTION ACP SYSTEM manufactured by Nuvasive Inc.

MAUDE Entry Details

Report Number2031966-2020-00055
MDR Report Key9876173
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-24
Date of Report2020-03-20
Date of Event2019-01-11
Date Mfgr Received2020-02-25
Date Added to Maude2020-03-24
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 ContactMR. GEORGE PANFILI
Manufacturer Street7475 LUSK BLVD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer G1NUVASIVE, INC.
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

Brand NameNUVASIVE HELIX REVOLUTION ACP SYSTEM
Generic NameAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Product CodeKWQ
Date Received2020-03-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNUVASIVE INC
Manufacturer Address7475 LUSK BLVD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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