T-PAL SPACER APPLICATOR INNER SHAFT 03.812.003

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 2019-11-04 for T-PAL SPACER APPLICATOR INNER SHAFT 03.812.003 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2019-61945
MDR Report Key9272089
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-11-04
Date of Report2019-10-16
Date Mfgr Received2019-11-06
Date Added to Maude2019-11-04
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 H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameT-PAL SPACER APPLICATOR INNER SHAFT
Generic NameINTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR
Product CodeMAX
Date Received2019-11-04
Model Number03.812.003
Catalog Number03.812.003
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2019-11-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.