UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-11-12 for UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2019-52383
MDR Report Key9309546
Report SourceOTHER
Date Received2019-11-12
Date of Report2019-10-14
Date Mfgr Received2019-10-14
Date Added to Maude2019-11-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
Generic NameORTHOSIS, SPINAL PEDICLE FIXATION
Product CodeMNI
Date Received2019-11-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDEPUY SPINE INC
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-12

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