VEGA NV Ø3.5 X 12MM /VEGA RV Ø4.0 X 10MM IMPLANT

Additional Manufacturer Narrative

AFTER THE TECHNICAL ANALYSIS OF THE INCIDENT, IT IS CONCLUDED THAT:THE LOSS OF FIT IN THE SEATING BETWEEN THE PROSTHESIS AND THE IMPLANTS DOES NOT DISTRIBUTE THE MASTICATORY LOAD EVENLY AND, CONSEQUENTLY, INCREASES THE LIKELIHOOD OF GENERATING DEFECTS IN THE IMPLANT THAT WILL INDUCE ITS BREAKAGE DUE TO MATERIAL FATIGUE.

Description of Event or Problem

A DISTRIBUTOR INFORMS SOADCO, S.L. THAT A DOCTOR HAS INFORMED THEM OF THE BREAKAGE OF TWO IMPLANTS IN A BRIDGE. IN ADDITION, THE DISTRIBUTOR INFORMS THAT THE MANUFACTURER OF THE PROSTHESIS IS UNKNOWN AND IT IS NOT POSSIBLE TO MAKE A HISTORY OF THE MATERIAL USED, BUT IT IS CONFIRMED THAT IT IS A COBALT CHROME PROSTHESIS.