inforMED
InjuryNHA

Atlantis Abutment Ti

Received Jul 31, 2026

Report 1222802-2026-00220 · MDR key 50097884

Device

Generic name

Abutment, Implant, Dental, Endosseous

Manufacturer

Dentsply Ih Inc.

Catalog number

35502

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.