VEGA RV IMPLANT Ø4.0 X 10MM

Description of Event or Problem

THE CUSTOMER COMMENTS IN THE QR (QUALITY REPORT) THAT HE HAS PROCEEDED TO ITS EXTRACTION OF THE DENTAL IMPLANT DATED (B)(6) 2019 (2 YEARS AFTER ITS PLACEMENT) - (B)(6) 2017) AFTER THE RUPTURE OF THIS IMPLANT. IN THE SAME QR THE CLIENT COMMENTS THAT IS A BONE TYPE D1 AND THE GINGIVA STATE IS LACK OF INFLAMATION. PATIENT (66-YEAR-OLD FEMALE).

Additional Manufacturer Narrative

MANIPULATION OF THE PROSTHESIS SEATING RESULTS IN A LOSS OF FIT TOLERANCE AT THE IMPLANT-PROSTHESIS INTERFACE. THIS MISALIGNMENT INCREASES THE MICROMOVEMENT BETWEEN THE TWO SURFACES, WHICH INDUCES LOCALIZED OVERLOAD ON THE IMPLANT EACH TIME MASTICATION OCCURS. THIS OVERLOAD GENERATES LOCALIZED FRICTION AT THE IMPLANT-PROSTHESIS INTERFACE, WHICH CAN ULTIMATELY GENERATE A FATIGUE FAILURE IN THE DENTAL IMPLANT.