MalfunctionHXY
TRINICA ANTERIOR CERVICAL PLATE SYSTEM
Received Dec 31, 2008 · Event occurred Dec 2, 2008
Report 2184052-2008-00036 · MDR key 1302848
Device
Generic name
Trinica Ato Swivel Ato Drill Guide
Manufacturer
Zimmer Spine, Inc.Model number
07.00796.001Catalog number
07-00796.001
Lot number
P040129
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- Surgery, prolonged
- Foreign body, removal of
Narrative
Additional Manufacturer Narrative
DEVICE HISTORY RECORDS REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION.
Description of Event or Problem
WHILE IMPLANTING THE TRINICA PLATE AND SCREWS AT C5-C7 A DISTAL PORTION OF THE DEVICE BROKE OFF AND LODGED BELOW THE PLATE. THE SURGEON WAS ABLE TO REMOVE THE BROKEN PORTION OF THE DEVICE. THIS ADDED AN ADDITIONAL 30 MINUTES TO THE SURGERY.