WECK SYSTEMS 6MM OSTEOTOME *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-07 for WECK SYSTEMS 6MM OSTEOTOME * manufactured by Weck Systems.

Event Text Entries

[16362114] Osteotome -6mm- broke during use septorhinoplasty - no pt injury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1028372
• MDR Report Key: 458680
• Date Received: 2003-05-07
• Date of Report: 2003-05-07
• Date of Event: 2003-04-16
• Date Added to Maude: 2003-05-12
• 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: WECK SYSTEMS
• Generic Name: SCRAPING DEVICE
• Product Code: KDG
• Date Received: 2003-05-07
• Model Number: 6MM OSTEOTOME
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 447643
• Manufacturer: WECK SYSTEMS
• Manufacturer Address: 2917 WECK DR P.O.BOX 12600 RESEARCH TRIANGLE PARK NC 27709 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2003-05-07