X25 FINAL TIGHTENER 279712600

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-17 for X25 FINAL TIGHTENER 279712600 manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2020-00724
MDR Report Key9841963
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-17
Date of Report2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2019-05-06
Date Added to Maude2020-03-17
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1BRIDGEWATER DISTRIBUTION
Manufacturer Street50 SCOTLAND BOULEVARD
Manufacturer CityBRIDGEWATER MA 02324
Manufacturer CountryUS
Manufacturer Postal Code02324
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameX25 FINAL TIGHTENER
Generic NameDRIVER
Product CodeHWR
Date Received2020-03-17
Returned To Mfg2020-03-10
Model Number279712600
Catalog Number279712600
Lot NumberGM5369509
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-17

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