10MM, 06?, LUNA IMPLANT, PEEK LUN20006-10

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-27 for 10MM, 06?, LUNA IMPLANT, PEEK LUN20006-10 manufactured by Benvenue Medical, Inc..

MAUDE Entry Details

Report Number3007033608-2019-00007
MDR Report Key9386611
Report SourceUSER FACILITY
Date Received2019-11-27
Date of Report2019-10-27
Date of Event2019-10-28
Date Mfgr Received2019-10-28
Device Manufacturer Date2019-05-28
Date Added to Maude2019-11-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LAURENT SCHALLER
Manufacturer Street4590 PATRICK HENRY DRIVE
Manufacturer CitySANTA CLARA CA 95054
Manufacturer CountryUS
Manufacturer Postal95054
Manufacturer Phone4084549300
Manufacturer G1BENVENUE MEDICAL, INC.
Manufacturer Street4590 PATRICK HENRY DRIVE
Manufacturer CitySANTA CLARA CA 95054
Manufacturer CountryUS
Manufacturer Postal Code95054
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name10MM, 06?, LUNA IMPLANT, PEEK
Generic Name10MM, 06?, LUNA IMPLANT, PEEK
Product CodeMAX
Date Received2019-11-27
Returned To Mfg2019-09-20
Model NumberLUN20006-10
Catalog NumberLUN20006-10
Lot Number19141006
Device Expiration Date2019-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBENVENUE MEDICAL, INC.
Manufacturer Address4590 PATRICK HENRY DRIVE SANTA CLARA CA 95054 US 95054


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-27

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