InjuryNHA
S Atlantis Abutment Ti
Received Jul 29, 2026 · Event occurred Jul 8, 2026
Report 1222802-2026-00207 · MDR key 50067327
Device
Product problems
- Fracture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that a patient experienced a fracture of a dental abutment screw.
Additional Manufacturer Narrative
Since this event resulted in a serious injury, it is reportable per 21 CFR Part 803. The device was not evaluated because the issue is a known inherent risk of the device. We will continue to track and monitor the trend.