PSS SYSTEM SLP4540

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-02-10 for PSS SYSTEM SLP4540 manufactured by Precision Spine, Inc..

MAUDE Entry Details

Report Number3005739886-2020-00004
MDR Report Key9687622
Report SourceDISTRIBUTOR,USER FACILITY
Date Received2020-02-10
Date of Report2020-01-10
Date of Event2019-12-20
Date Facility Aware2019-12-23
Report Date2019-12-23
Date Reported to FDA2019-12-23
Date Mfgr Received2020-01-10
Date Added to Maude2020-02-10
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 NamePSS SYSTEM
Generic NamePEDICLE SCREW
Product CodeMNH
Date Received2020-02-10
Model NumberSLP4540
Catalog NumberSLP4540
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
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 2020-02-10

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