*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-03 for * manufactured by *.

Event Text Entries

[15490277] Osteotome broke during use intro-op, pieces removed from surgical site.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 681989
• MDR Report Key: 681989
• Date Received: 2006-03-03
• Date of Report: 2006-03-01
• Date of Event: 2006-02-21
• Date Facility Aware: 2006-02-21
• Report Date: 2006-02-21
• Date Reported to FDA: 2006-03-01
• Date Added to Maude: 2006-03-08
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: *
• Generic Name: *
• Product Code: GFI
• Date Received: 2006-03-03
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 671256
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-03-03