REFORM POCT SYSTEM 55-IN-0110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-30 for REFORM POCT SYSTEM 55-IN-0110 manufactured by Precision Spine, Inc..

MAUDE Entry Details

Report Number3005739886-2020-00013
MDR Report Key9898115
Report SourceDISTRIBUTOR
Date Received2020-03-30
Date of Report2020-03-03
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-30
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 ContactMIKE DAWSON
Manufacturer Street2050 EXECUTIVE DR
Manufacturer CityPEARL MS 39208
Manufacturer CountryUS
Manufacturer Postal39208
Manufacturer Phone6014204244
Manufacturer G1PRECISION SPINE, INC.
Manufacturer Street2050 EXECUTIVE DR
Manufacturer CityPEARL MS 39208
Manufacturer CountryUS
Manufacturer Postal Code39208
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREFORM POCT SYSTEM
Generic NameROD PUSHER
Product CodeLXH
Date Received2020-03-30
Model Number55-IN-0110
Catalog Number55-IN-0110
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPRECISION SPINE, INC.
Manufacturer Address2050 EXECUTIVE DR PEARL MS 39208 US 39208


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-30

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