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ATLANTIS® 35503 (UDI 07392532291630)Recalls & reported problems

Dentsply Ih, Inc. · ATLANTIS Abutment Goldshaded Ti · Class 2 · Implant

Adverse event reports
8
Deaths reported
0
Injuries reported
8
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07392532291630), received between Dec 30, 2025 and Sep 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Fracture” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 3 reportsJun 2026: 1 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture6
  • Failure to Osseointegrate2

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Failure of Implant3

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50941511 ↗
  • InjuryJul 28, 2026Fracture

    It was reported that a patient experienced a dental abutment breakage.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50052402 ↗
  • InjuryJun 1, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25350887 ↗
  • InjuryMay 26, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL SCREW.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25295339 ↗
  • InjuryMay 26, 2026Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25279072 ↗
  • InjuryMay 21, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED FRACTURES OF THE DENTAL IMPLANT AND ABUTMENT. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.

    Patient problems: Failure of Implant

    MAUDE report 25241152 ↗
  • InjuryFeb 18, 2026Failure to Osseointegrate

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.

    Patient problems: Failure of Implant

    MAUDE report 24379091 ↗
  • InjuryDec 30, 2025Fracture; Fracture

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.

    Patient problems: Failure of Implant

    MAUDE report 23921256 ↗

Other Abutment, implant, dental, endosseous devices

All Abutment, implant, dental, endosseous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.