1.3MM CURVILINEAR DISTRACTOR R50/RIGHT 04.500.250

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 2020-02-10 for 1.3MM CURVILINEAR DISTRACTOR R50/RIGHT 04.500.250 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-00729
MDR Report Key9687045
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-10
Date of Report2020-01-14
Date of Event2019-08-08
Date Mfgr Received2020-02-03
Device Manufacturer Date2018-07-24
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
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 G1WERK BALSTHAL (CH)
Manufacturer StreetDORNACHERSTRASSE 20
Manufacturer CityBALSTHAL CO 4710
Manufacturer CountrySZ
Manufacturer Postal Code4710
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name1.3MM CURVILINEAR DISTRACTOR R50/RIGHT
Generic NameMANDIBLE DISTRACTION DEVICES
Product CodeMQN
Date Received2020-02-10
Returned To Mfg2020-02-03
Model Number04.500.250
Catalog Number04.500.250
Lot NumberL983476
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
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 2020-02-10

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