PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE 399.37

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-15 for PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE 399.37 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2019-61545
MDR Report Key9191798
Report SourceHEALTH PROFESSIONAL
Date Received2019-10-15
Date of Report2019-09-20
Date of Event2019-09-18
Date Mfgr Received2019-10-30
Date Added to Maude2019-10-15
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 Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1SYNTHES TUTTLINGEN
Manufacturer StreetUNTER HASSLEN 5
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE
Generic NameELEVATOR
Product CodeHTE
Date Received2019-10-15
Returned To Mfg2019-10-23
Model Number399.37
Catalog Number399.37
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-15

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