MAYFIELD 4-1-C-1216 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-02-10 for MAYFIELD 4-1-C-1216 * manufactured by Omi-mayfield C/o Surgical West, Inc..

Event Text Entries

[177929] Pt's head was placed in 3 points mayfield at beginning of surgical procedure. During wound closure, pt's head sank. Readjusted and retightened mayfield but no loose connections were identified. Later, co rep said swivel lock was loose and required repair.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 261611
• MDR Report Key: 261611
• Date Received: 2000-02-10
• Date Facility Aware: 2000-01-21
• Report Date: 2000-02-10
• Date Reported to FDA: 2000-02-10
• Date Reported to Mfgr: 2000-02-10
• Date Added to Maude: 2000-02-11
• 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: MAYFIELD
• Generic Name: HEAD REST
• Product Code: HBM
• Date Received: 2000-02-10
• Returned To Mfg: 2000-02-01
• Model Number: 4-1-C-1216
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 253366
• Manufacturer: OMI-MAYFIELD C/O SURGICAL WEST, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2000-02-10