OSTEOTOME UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for OSTEOTOME UNK * manufactured by Hall Surgical.

Event Text Entries

[60243] Notified mfr 10/3/94 - breakage regarding an osteotome which was being utilized during surgery. Both pieces were secured. No injury to the pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 86708
• MDR Report Key: 86708
• Date Received: 1995-02-15
• Date of Report: 1995-01-26
• Date of Event: 1994-08-22
• Date Added to Maude: 1997-04-29
• 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: 0
• 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: OSTEOTOME
• Generic Name: USED TO SHAVE BONE ON ORTHOPEDIC SURGERY
• Product Code: GFI
• Date Received: 1995-02-15
• Model Number: UNK
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 19443
• Manufacturer: HALL SURGICAL
• Manufacturer Address: 1170 MARK AVE CARPENTERIA CA 930132918 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1995-02-15