UNKNOWN MONO/POLYAXIAL SCREWS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-30 for UNKNOWN MONO/POLYAXIAL SCREWS manufactured by Depuy Spine Inc.

MAUDE Entry Details

Report Number1526439-2020-00798
MDR Report Key9901056
Report SourceFOREIGN,LITERATURE
Date Received2020-03-30
Date of Report2020-03-03
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 ContactKARA DITTY-BOVARD
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Manufacturer Phone6103142063
Manufacturer G1MEDOS INT SPINE
Manufacturer StreetCHEMIN BLANC 38
Manufacturer CityLE LOCLE
Manufacturer CountrySZ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN MONO/POLYAXIAL SCREWS
Generic NameORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
Product CodeMNH
Date Received2020-03-30
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 2020-03-30

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