Atlantis IO FLO IO-P-04
Received Jul 30, 2026
Report 1222802-2026-00215 · MDR key 50088731
Device
Product problems
- Mechanical Problem
Patient
Not reported
- Failure of Implant
Narrative
Description of Event or Problem
It was reported that a scan body issue occurred. The customer reported being unable to fully seat the Atlantis scan body due to interference at the implant-abutment interface.The implant was placed and buried, then uncovered three months later for placement of a healing abutment. Reverse torque testing demonstrated implant stability at 30 Ncm, and the patient reported no pain.Multiple attempts were made to seat the scan body; however, it could not be fully seated. Periapical radiographs were obtained, and the patient returned for a follow-up appointment with the sales representative. Additional intraoral photographs and periapical radiographs were taken. Based on the clinical and radiographic evaluation, a defect at the base of the implant was identified, preventing the scan body from fully seating. The customer was advised to remove the implant, perform bone grafting, and replace the implant.
Additional Manufacturer Narrative
This report is for the dental abutment device. The dental implant device report will be submitted separately. Products return is requested and they will be evaluated after receipt. In case any new or additional information will be gained from this investigation a Follow-up report will be sent. Trend is tracked and monitored.