UNKNOWN T-HANDLE UNK_OFL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-07 for UNKNOWN T-HANDLE UNK_OFL manufactured by Mako Surgical Corp..

MAUDE Entry Details

Report Number3005985723-2019-00719
MDR Report Key9161305
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-07
Date of Report2019-10-07
Date of Event2019-09-09
Date Mfgr Received2019-09-09
Date Added to Maude2019-10-07
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 ContactMR. COLLIN NEITZEL
Manufacturer Street325 CORPORATE DRIVE
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2018315000
Manufacturer G1MAKO SURGICAL CORP.
Manufacturer Street2555 DAVIE ROAD
Manufacturer CityFORT LAUDERDALE FL 33317
Manufacturer CountryUS
Manufacturer Postal Code33317
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN T-HANDLE
Generic NamePROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
Product CodeNPJ
Date Received2019-10-07
Catalog NumberUNK_OFL
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMAKO SURGICAL CORP.
Manufacturer Address2555 DAVIE ROAD FORT LAUDERDALE FL 33317 US 33317


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-07

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