RIGHT TOTAL WRIST CARPAL COMPONENT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-25 for RIGHT TOTAL WRIST CARPAL COMPONENT * manufactured by Kinetikos Medical Incorporated.

Event Text Entries

[497964] Stem broke on the metal plate of the implant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039847
• MDR Report Key: 752068
• Date Received: 2006-07-25
• Date of Report: 2006-07-25
• Date of Event: 2006-06-14
• Date Added to Maude: 2006-08-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RIGHT TOTAL WRIST CARPAL COMPONENT
• Generic Name: *
• Product Code: KWN
• Date Received: 2006-07-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 739853
• Manufacturer: KINETIKOS MEDICAL INCORPORATED
• Manufacturer Address: 6005 HIDDEN VALLEY RD SUITE 180 CARLSBAD CA 92011 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2006-07-25