MICRO TREPHINATION SYSTEM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-13 for MICRO TREPHINATION SYSTEM * manufactured by Xomed - Treace, Inc..

Event Text Entries

[158184] Pt was undergoing left frontal sinus trephination. Probe tip from trephination instrument broke off in left frontal bone. Sinus irrigated with saline.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017003
• MDR Report Key: 236773
• Date Received: 1999-08-13
• Date of Report: 1999-07-26
• Date of Event: 1999-07-20
• Date Added to Maude: 1999-08-25
• 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: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MICRO TREPHINATION SYSTEM
• Generic Name: MICRO TREPHINATION SYSTEM
• Product Code: KBF
• Date Received: 1999-08-13
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 229455
• Manufacturer: XOMED - TREACE, INC.
• Manufacturer Address: 6743 SOUTHPOINT DR NORTH JACKSONVILLE FL 322160980 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-08-13