INNER SHAFT, STANDARD INSERTER 137M0003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2019-11-20 for INNER SHAFT, STANDARD INSERTER 137M0003 manufactured by Zimmer Biomet Spine Inc..

MAUDE Entry Details

Report Number3012447612-2019-00443
MDR Report Key9351486
Report SourceDISTRIBUTOR,HEALTH PROFESSION
Date Received2019-11-20
Date of Report2019-11-20
Date of Event2019-10-14
Date Mfgr Received2019-10-21
Date Added to Maude2019-11-20
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 ContactMS. ASHLEY MCPHERSON
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal80021
Manufacturer Phone3034437500
Manufacturer G1ZIMMER BIOMET SPINE INC.
Manufacturer Street10225 WESTMOOR DR. NA
Manufacturer CityWESTMINSTER CO 80021
Manufacturer CountryUS
Manufacturer Postal Code80021
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameINNER SHAFT, STANDARD INSERTER
Generic NameZYSTON STRUT OPEN TITANIUM SPACER SYSTEM
Product CodeMAX
Date Received2019-11-20
Model NumberNA
Catalog Number137M0003
Lot Number984801
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerZIMMER BIOMET SPINE INC.
Manufacturer Address10225 WESTMOOR DR. NA WESTMINSTER CO 80021 US 80021


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-20

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