CERVICAL MANAGEMENT BASE UNIT SWIVEL ADAPTER 5979-323

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-20 for CERVICAL MANAGEMENT BASE UNIT SWIVEL ADAPTER 5979-323 manufactured by Mizuho Orthopedic Systems, Inc..

Event Text Entries

[183887918] Customer reported some broken parts were epoxied back together, but broke again along the glue line. There was no injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2921578-2020-00003
MDR Report Key9606609
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-01-20
Date of Report2020-02-21
Date Mfgr Received2020-01-07
Date Added to Maude2020-01-20
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 ContactANNE LEBLANC
Manufacturer Street30031 AHERN AVENUE
Manufacturer CityUNION CITY, CA CA 945871234
Manufacturer CountryUS
Manufacturer Postal945871234
Manufacturer Phone5104291500
Manufacturer G1MIZUHO ORTHOPEDIC SYSTEMS, INC.
Manufacturer Street30031 AHERN AVENUE
Manufacturer CityUNION CITY, CA CA 945871234
Manufacturer CountryUS
Manufacturer Postal Code945871234
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCERVICAL MANAGEMENT BASE UNIT SWIVEL ADAPTER
Generic NameHEAD/NECK PROCEDURE POSITIONER
Product CodeJEA
Date Received2020-01-20
Model Number5979-323
Catalog Number5979-323
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMIZUHO ORTHOPEDIC SYSTEMS, INC.
Manufacturer Address30031 AHERN AVENUE UNION CITY, CA CA 945871234 US 945871234


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.