VEGA® RV IMPLANT Ø4.0 X 10MM

Additional Manufacturer Narrative

THE LOSS OF FIT DURING SEATING BETWEEN THE PROSTHESIS AND THE IMPLANT DOES NOT DISTRIBUTE THE MASTICATORY LOAD EVENLY AND, CONSEQUENTLY, INCREASES THE LIKELIHOOD OF GENERATING DEFECTS IN THE IMPLANT THAT WILL LEAD TO ITS FAILURE DUE TO MATERIAL FATIGUE. THEREFORE, THIS LOSS OF FIT HAS A DIRECT IMPACT ON THE DISTRIBUTION OF THE MASTICATORY LOAD ON THE IMPLANT AND, CONSEQUENTLY, ON ITS MECHANICAL AND FATIGUE RESISTANCE.

Description of Event or Problem

AN BROKEN IMPLANT IS RECEIVED AT SOADCO S.L. FACILITIES WHERE THE MANUFACTURER AND THE STATE OF THE PROSTHESIS PLACED IS UNKNOWN (CAUSE: BREAKAGE OF THE IMPLANT IN THE PATIENT). THIS IMPLANT PRESENTS A PLASTIC DEFORMATION OF THE MATERIAL. PREVIOUSLY A CLAIM HAS BEEN RECEIVED FOR THIS SAME IMPLANT MODEL AND MANUFACTURING LOT. THIS INCIDENCE IS DIRECTLY RELATED TO THE LOSS OF ADJUSTMENT BETWEEN THE PROSTHESIS AND THE IMPLANT.