MAYFIELD HEADREST *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-06-30 for MAYFIELD HEADREST * manufactured by Ohio Medical Instrument Co..

Event Text Entries

[15610454] Hartford hosp submits this report pursuant to 21cfr803. This report is based on info reviewed by hartford hosp which it may not have had an opportunity to investigat fully or verify prior to the reporting date. This report shall not be construed as an admission by hartford hosp that it or any of its employees or affiliates caused or contributed to the incident describe herein. Pt in prone position in or for cervical laminectomy. Mayfield head pins placed and headrest locked in place. The pin which holds the headrest in position released itself and the pt's head fell out and was caught by the surgeon.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	107778
MDR Report Key	107778
Date Received	1997-06-30
Date of Report	1997-04-14
Date of Event	1997-04-10
Date Facility Aware	1997-04-10
Report Date	1997-04-11
Date Reported to Mfgr	1997-04-11
Date Added to Maude	1997-07-28
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 HEADREST
Generic Name	HEADREST
Product Code	HBM
Date Received	1997-06-30
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	R
Device Age	UNKNOWN
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	105934
Manufacturer	OHIO MEDICAL INSTRUMENT CO.
Manufacturer Address	3942 VIRGINIA AVE. CINCINNATI OH 45227 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-06-30