UNIVERSAL 2 TOTAL WRIST IMPLANT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-22 for UNIVERSAL 2 TOTAL WRIST IMPLANT * manufactured by Kmi, Inc..

Event Text Entries

[304263] Breakage of carpal component of universal 2 total wrist implant. Implant fracture through the carpal component stem. Was noted approximately one year post op for the first time, but may have been present earlier.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1029402
MDR Report Key481387
Date Received2003-08-22
Date of Report2003-08-22
Date of Event2003-08-11
Date Added to Maude2003-09-05
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameUNIVERSAL 2 TOTAL WRIST IMPLANT
Generic NameTOTAL WRIST IMPLANT
Product CodeKWM
Date Received2003-08-22
Model NumberUNIVERSAL 2
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key470274
ManufacturerKMI, INC.
Manufacturer Address* SAN DIEGO CA * US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2003-08-22

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