BREMER 3D HALO CROWN SYSTEM

Description of Event or Problem

INITIAL APPLICATION OF A SKULL BRACE WAS DONE FOR DENS FRACTURE IN 2008. THE USER NOTED THAT WHEN HE TIGHTENED THE PINS TO SET THE PRODUCT ON THE PATIENT, ONE OF THE LEFT POSTERIOR PINS WAS LOOSE AND EASILY MOVED FORWARD. THE CONTACT IN OTHER COUNTRY REPORTED THAT THE SKULL PIN HAD BEEN RE-TIGHTENED AFTER THE INITIAL FITTING. THE FOLLOWING MONTH, IT WAS FOUND THE SKULL PIN HAD PENETRATED THROUGH THE BONE. CONTACT REPORTED NO SIGNIFICANT PATIENT COMPLICATION AT THIS TIME.

Additional Manufacturer Narrative

NOTE: THIS EVENT OCCURRED WITH A STERILE VERSION OF THE 3D CROWN THAT IS SOLD ONLY IN OTHER COUNTRY (CATALOG NUMBER 292301001). AS THE EQUIVALENT DEVICE, NON-STERILE, IS SOLD IN THE USA AS WE HAVE FILED THIS MDR USING THE FDA CLEARED CATALOG NUMBER. NO CONNECTION COULD BE MADE BETWEEN THE REPORTED EVENT AND ANY SHORTCOMING OF THE DEVICE. CARE MUST BE TAKEN DURING APPLICATION AND SUBSEQUENT TIGHTENING TO ENSURE THAT SKULL PINS DO NOT ADVANCE THROUGH THE BONE.