EFIX
Received Nov 15, 2011 · Event occurred Oct 18, 2011
Report 2520274-2011-00691 · MDR key 2380955
Device
Product problems
- Device Operates Differently Than Expected
Patient
19 YR
- Pain
Narrative
Description of Event or Problem
A MRI TECHNICIAN FROM HOSPITAL ACCOUNT REPORTED A (B)(6) OLD MALE PATIENT STATUS POST EX-FIX IMPLANTATION ON AN UNKNOWN DATE WAS SCHEDULED FOR A MRI SCAN CONSISTING OF SEVEN SCANS. A PHASED ARRAY BODY COIL WAS USED AROUND THE KNEE FOR THE SCAN. THE EX-FIX FRAME WAS TOTALLY WRAPPED IN GAUZE AND THE PINS WERE CLOSE TO, BUT NOT TOUCHING THE SIDE OF THE COIL. DURING THE FIRST SCAN PATIENT EXPERIENCED SEVERE PAIN FROM THE KNEE TO THE ANKLE. THE FIRST SCAN WAS COMPLETED IN FOUR AND ONE HALF MINUTES. AFTER THE SCAN WAS COMPLETED THE PAIN WENT AWAY IMMEDIATELY. TECHNICIAN ABORTED THE REMAINING SIX SCANS. MRI SAFE DOCUMENTATION FOR FIXATORS HAD BEEN SENT TO THE TECHNICIAN IN NOVEMBER 2010 BY SYNTHES AND THERE WERE NO PROBLEMS WITH EXTERNAL FIXATOR SCANS UNTIL THIS PATIENT.
Additional Manufacturer Narrative
WITHOUT A LOT NUMBER THE DEVICE HISTORY REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RETURNED.