TYPE-S HEAD EXTENSION
Received Apr 20, 2007 · Event occurred Mar 26, 2007
Report 1932738-2007-00001 · MDR key 950580
Device
Generic name
Carbon Fiber Couch Insert
Manufacturer
Civco Medical Solutions, Med-tec Inc.Model number
20-CFHN-SUB2-VCatalog number
20-CFHN-SUB2-V
Lot number
2901
Product problems
- Break
Patient
YR
- Fall
- Pain
- Discomfort
- Therapy/non-surgical treatment, additional
Narrative
Description of Event or Problem
CIVCO WAS NOTIFIED THAT A TYPE-S HEAD EXTENSION JOINT BROKE NEAR THE LOCKING MECHANISM AND ALLOWED THE PATIENT TO FALL. THE PATIENT WAS LYING FLAT ON THEIR BACK AS THEY ADJUSTED THEMSLEF OF THE TYPE-S HEAD EXTENSION. THE TYPE-S HEAD EXTENSION BROKE AND THE PATIENT FELL ABOUT 2-3 FEET. THE PATIENT WAS EVALUATED BY X-RAY AND NO INJURY WAS IDENTIFIED.
Additional Manufacturer Narrative
CLINICIAN/HOSPITAL GLUED JOINT TOGETHER PRIOR TO RETURNING FOR EVALUATION WHICH MADE EVALUATION OF THE ORIGINAL JOINT ADHESIVE IMPOSSIBLE. PATIENT REPOSITIONED SELF PUTTING EXCESSIVE PRESSURE ON WORN DEVICE. INSTRUCTIONS FOR USE DESCRIBES AND DIAGRAMS CORRECT REPOSITIONING PROCESS OF PATIENT/CLINICIAN. INSTRUCTIONS FOR USE INDICATE TO INSPECT FOR DAMAGE/WEAR PRIOR TO USE AND NOT TO USE A DAMAGED DEVICE.
Remedial action
- Replace