ATLANTIS® 35503 (UDI 07392532083440)Recalls & reported problems
Dentsply Ih, Inc. · ATLANTIS Abutm Goldshaded Ti · Class 2 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07392532083440), received between Oct 25, 2023 and Sep 22, 2026 — classified as 20 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (15 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
Most reported problems
Device problems
- Fracture15
- Separation Failure4
- Difficult to Insert1
- Product Quality Problem1
Patient problems
- Failure of Implant17
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Fracture
It was reported that a patient experienced a fracture of a dental screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858763 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360655 ↗MalfunctionMay 28, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25317221 ↗InjuryMay 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25292526 ↗InjuryJan 2, 2026Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: Failure of Implant
MAUDE report 23942506 ↗InjuryOct 28, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ATLANTIS ABUTMENT SCREW BREAKAGE. THE BROKEN PIECE COULD NOT BE RETRIEVED AND THE STRAUMANN DENTAL IMPLANT HAD TO BE EXPLANTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 23402624 ↗InjuryJun 13, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT AN ATLANTIS ABUTM GOLDSHADED TI FRACTURED AND CAUSED THE PATIENT TO EXPERIENCE AN IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22202366 ↗InjuryMar 26, 2025Fracture; Fracture
IN THIS EVENT A ATLANTIS ABUTM GOLDSHADED TI FRACTURED. THE IMPLANT IN POSITION 16 ALSO FRACTURED WITH ATLANTIS ABUTMENT AND A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21697151 ↗InjuryMar 20, 2025Separation Failure; Separation Failure
IT IS REPORTED THAT FRACTURE OF ABUTMENT SCREW (ANKYLOS IMPLANT) WILL SEND RETRIEVAL TOOLS (B)(6). DOCTOR STATED THE THREAD BASKET NEEDS TO BE RETRIEVED BUT SEEMS CONFIDENT THAT IMPLANT WILL BE LOADABLE ONCE IT'S BEEN REMOVED. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21654670 ↗InjuryJan 20, 2025Fracture; Fracture
A FRACTURED ABUTMENT RESULTED IN A PATIENT THAT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21192994 ↗InjuryNov 11, 2024Fracture; Fracture
IN THIS EVENT IT IS REPORTED THAT AN ABUTMENT WAS DAMAGED WHICH LEADED TO IMPLANT FRACTURE. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20660210 ↗InjuryOct 4, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO ABUTMENT FIT.
Patient problems: Failure of Implant
MAUDE report 20372981 ↗InjuryJun 26, 2024Fracture; Fracture
SCREW BROKE. ANKYLOS IMPLANT MAY NEED TO BE TREPHINED OUT. DOCTOR HAS ORDERED TREPHINE DRILL TO REMOVE IMPLANT. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19613674 ↗InjuryJun 4, 2024Fracture; Fracture
FRACTURE OF ABUTMENT :THE ABUTMENT BROKE ITSELF. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19459473 ↗InjuryJun 4, 2024Fracture; Fracture
FRACTURE OF ABUTMENT : THE ABUTMENT ON TOOTH 36 BROKE ITSELF. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19459447 ↗InjuryApr 9, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19069649 ↗InjuryMar 22, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18960016 ↗InjuryMar 13, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18894878 ↗InjuryFeb 7, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18657913 ↗InjuryNov 20, 2023Fracture; Fracture
FRACTURE OF ABUTMENT: IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18170948 ↗InjuryOct 25, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18005357 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.