ESSENTIAL® CONE Ø4.0 X 12MM IMPLANT

Additional Manufacturer Narrative

THE MAIN CAUSE OF THE LOSS MAY HAVE BEEN BONE DIS-INTEGRATION DUE TO MECHANICAL OVERLOAD BECAUSE OF POOR OSSEOUS INTEGRATION OF THE IMPLANT INTO THE BONE. THIS EXPLAINS THE INITIAL STABILITY OF THE IMPLANT AT THE TIME OF IMPLANT CONNECTION BUT WITH SUBSEQUENT MARGINAL BONE REMODELLING AFTER LOADING THE RESIDUAL BONE-IMPLANT CONTACT HAS NOT BEEN ABLE TO WITHSTAND THE FUNCTIONAL DEMAND.

Description of Event or Problem

THE CLINICIAN REPORTS THAT ON THE (B)(6) 2017 THE IMPLANT WAS PLACED IN POSITION #2 AND THEN ON THE (B)(6) 2018 HE PLACED AN ABUTMENT APPLYING 30NCM TORQUE AND THAT IT SHOWED IDEAL CLINICAL STABILITY, ABSENCE OF MOBILITY, ABSENCE OF RADIOLUCID RADRIOGRAPHIC IMAGES AND ABSENCE OF SYMPTOMATOLOGY. THEN, ON THE (B)(6) /2018 THE PROSTHESIS WAS PLACED. HOWEVER, ON THE (B)(6) 2018 HE HAD TO EXTRACT THE IMPLANT SINCE THE PATIENT REPORTS THAT AT MASTICATION HE FELT THE CROWN LOSE AND HE TRIED TO REMOVE IT BY HIMSELF AND PAIN STARTED. THE PATIENT EXPERIENCED PAIN AND INFLAMATION, AT MASTICATION, FEW DAYS BEFORE THE IMPLANT WAS REMOVED. A NORMAL SURGICAL PROCEDURE WAS APPLIED.