SAFHS SONIC ACCELERATED FRACTURE HEALING SYSTEM
Received Apr 15, 1996
Report MW5000017 · MDR key 34173
Device
Generic name
Fracture Healing System
Manufacturer
Exogen, Inc.Product problems
- Design/structure problem
- Defective Component
Patient
NO INFO
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
DEFECTIVE BRIDGE RECTIFIER. THE PT WAS SENT A REPLACEMENT SYSTEM. THE PROBLEM HAS BEEN ADDRESSED THROUGH THE USE OF A GLASS PASSIVATED, FULL WAVE BRIDGE RECTIFIER IN THE MAIN OPERATING UNIT (MOU). THIS UNIT WAS BUILT PRIOR TO IMPLEMENTATION OF THIS CORRECTIVE ACTION. NO FAILURES HAVE OCCURRED WITH THE NEW BRDIGE RECTIFIERS.