MODIFIED MAYFIELD SKULL CLAMP 600 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-07-14 for MODIFIED MAYFIELD SKULL CLAMP 600 * manufactured by Ohio Medical Instrument Co..

Event Text Entries

[321715] Pt positioned prone with mayfield pins in scalp. Positioned by md approx 30 minutes into surgery, pt's head slipped out of mayfield pins. Repositioned on horseshoe head rest by md and surgery continued.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 472337
• MDR Report Key: 472337
• Date Received: 2003-07-14
• Date of Report: 2003-07-11
• Date of Event: 2003-06-24
• Date Facility Aware: 2003-06-24
• Report Date: 2003-07-11
• Date Reported to Mfgr: 2003-07-11
• Date Added to Maude: 2003-07-21
• 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
• 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: MODIFIED MAYFIELD SKULL CLAMP
• Generic Name: MAYFIELD HEADREST
• Product Code: HBM
• Date Received: 2003-07-14
• Model Number: 600
• Catalog Number: *
• Lot Number: *
• ID Number: REF #A-1059
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 461190
• Manufacturer: OHIO MEDICAL INSTRUMENT CO.
• Manufacturer Address: 4900 CHARLEMAR DR. CINCINNATI OH 45227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-07-14