ESSENTIAL® CONE IMPLANT Ø3.5 X 10MM

Additional Manufacturer Narrative

AFTER THE ANALYSIS IT IS OBSERVED THAT THE CAUSE IS DUE TO THE FATIGUE OF THE IMPLANT AND WITH THE AVAILABLE INFORMATION IT CAN BE AFFIRMED THAT IN THIS INCIDENCE FACTORS SUCH AS THE ABUTMENT-IMPLANT GAP (THIS IS NOT UNIFORM) GENERATING FATIGUE AND BONE RESORPTION HAVE CONVERGED IN THE FAILURE OF THE DEVICE.

Description of Event or Problem

THE DOCTOR INFORMS SOADCO R&D MANAGEMENT ABOUT THE BREAKAGE OF AN IMPLANT. A FOLLOW-UP OF THE MANUFACTURING BATCHES IS CARRIED OUT WHERE IT IS VERIFIED THAT NO INCIDENTS HAVE BEEN DETECTED IN BOTH DEVICES. ON 12/07/2023 THE INFORMATION OF THE IMPLANT AND THE PROSTHESIS TOGETHER WITH THE BROKEN IMPLANT IS RECEIVED AT SOADCO'S FACILITIES. TO COMPLEMENT THE TECHNICAL INFORMATION, DR. HAS PROVIDED RADIOGRAPHS OF THE MOMENT OF TAKING THE IMPRESSION, PLACING THE PROSTHESIS AND REMOVING THE IMPLANT WHERE BONE LOSS IS OBSERVED AT THE TIME OF IMPLANT LOSS COMPARED TO THE DAY OF IMPRESSION TAKING AND PROSTHESIS PLACEMENT.