VEGA RV IMPLANT Ø4.5 X 0.8MM
Received Jun 18, 2025 · Event occurred Apr 10, 2018
Report 3003267134-2025-00004 · MDR key 22284568
Device
Product problems
- Loss of Osseointegration
- Loss of Osseointegration
Patient
53 YR · Male
- Inadequate Osseointegration
- Inadequate Osseointegration
Narrative
Additional Manufacturer Narrative
NOTHING TO HIGHLIGHT IN THE QUALITY CONTROLS.WITH THE INFORMATION AVAILABLE, IT CAN BE AFFIRMED THAT THIS INCIDENCE IS MORE RELATED TO THE ORAL HEALTH HABITS OF THE PATIENT THAN TO A TECHNICAL INCIDENCE OF THE PRODUCT. SINCE WE DO NOT HAVE CONTROL RADIOGRAPHS AT THE TIME OF PLACEMENT AND PRIOR TO EXTRACTION, WE CANNOT CONCLUDE THAT THERE HAS BEEN LOSS OF MARGINAL BONE OR INFECTIONS THAT COULD HAVE BEEN A CONDITIONING FACTOR FOR THE LOSS OF IT.
Description of Event or Problem
THE CUSTOMER COMMENTS IN THE QR (QUALITY REPORT) THAT HE HAS PROCEEDED TO THE EXTRACTION OF THE DENTAL IMPLANT DATED (B)(6) 2018 (APPROXIMATELY 9 MONTHS AFTER ITS PLACEMENT) - (B)(6) 2017). IN THE SAME QR THE CLIENT COMMENTS THAT A BONE GRAFT WAS PERFORMED ON THE PATIENT AND THAT AMONG POSSIBLE CAUSES THAT COULD HAVE ORIGINATED THE INCIDENCE IS THE INSUFFICIENT ORAL HYGIENE, THE BONE GRAFT AND THE SMOKING HABIT OF THE PATIENT (53-YEAR-OLD MALE).
Remedial action
- Notification