RESOLVE HALO

Additional Manufacturer Narrative

BASED ON INFORMATION KNOWN IT IS LIKELY NO FAILURE OR MALFUNCTION OCCURRED WITH THE DEVICE. THE EVENT LIKELY OCCURRED TO PIN PENETRATION, WHICH MAY HAVE BEEN DUE TO IMPROPER APPLICATION/MAINTENANCE OF THE PIN TIGHTNESS OR MAY HAVE BEEN DUE TO A FALL/IMPACT INCIDENT THAT WAS NOT RELATED TO A PRODUCT MALFUNCTION.

Description of Event or Problem

THE PATIENT HAD A HALO VEST FITTED, THIS WAS READJUSTED TO IMPROVE ALIGNMENT A FEW DAYS LATER. THE PATIENT WAS SUBSEQUENTLY READMITTED WITH A SEIZURE. IMAGING CONFIRMED THE POSTERIOR HALO PINS HAD BREACHED THE SKULL BILATERALLY AND THERE WAS MINOR BRAIN SWELLING. THE PATIENT WAS ADMITTED TO HOSPITAL, THE HALO VEST WAS REMOVED, AND THE PATIENT TREATED WITH ANTICONVULSANTS AND ANTIBIOTICS.