ATLANTIS® 35502 (UDI 07392532083433)Recalls & reported problems
Dentsply Ih, Inc. · ATLANTIS Abutment Ti · Class 2 · Implant
Quick summary
This Dentsply Atlantis titanium abutment is the piece that connects a dental implant to a crown. Most of the 69 reports describe parts breaking — fractured abutments, screws stripping or snapping, and crowns coming loose — sometimes leaving fragments behind so the implant itself has to be removed, and the bone not bonding to the implant. There are no deaths, 69 injuries, and no recalls name this device. Reports dropped from 29 in the prior 12 months to 10 in the most recent.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 66
- Deaths reported
- 0
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 07392532083433), received between Aug 1, 2023 and Sep 25, 2026 — classified as 65 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (35 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
- Fracture35
- Separation Failure28
- Failure to Osseointegrate4
Patient problems
- Failure of Implant61
- No Clinical Signs, Symptoms or Conditions4
- Inflammation1
- Laceration(s)1
- Pocket Erosion1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Fracture
It was reported that the abutment on tooth 16 fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899127 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364802 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364139 ↗InjuryApr 7, 2026Fracture
IT WAS REPORTED THAT THE ABUTMENT FRACTURED AND THE RESULTING FRAGMENT LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24802062 ↗InjuryFeb 18, 2026Separation Failure
ABUTMENT SCREW WAS STRIPPED AND ABUTMENT WAS FRACTURED AT CONNECTION; DUE TO THIS DAMAGE THE IMPLANT HAD TO BE REMOVED AS THE INTERNAL PORTION OF THE IMPLANT WAS DAMAGED AS WELL. THEY ORIGINALLY NOTICED PROBLEMS IN (B)(6) 2024 PER PT RECORDS OF THE ABUTMENT CROWN FALLING OFF AND SCREW STUCK IN THE IMPLANT BUT WE WERE NOT NOTIFIED UNTIL NOW. THE DAMAGED WAS REALIZED THEN IN (B)(6) 2025 AND IMPLANT WAS THEN EXPLANTED (B)(6) 2025.
Patient problems: Failure of Implant
MAUDE report 24377931 ↗InjuryFeb 5, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268231 ↗InjuryDec 2, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23700642 ↗InjurySep 10, 2025Separation Failure; Separation Failure
ANKYLOS ABUTMENT, ATLANTIS ABUTMENT TI, FRACTURED. THE IMPLANT WAS REMOVED AND THE DOCTOR IS UNSURE IF THE ABUTMENT WAS STOCK OR CUSTOM.
Patient problems: Failure of Implant
MAUDE report 23015966 ↗InjurySep 10, 2025Separation Failure; Separation Failure
ABUTMENT, S ATLANTIS ABUTMENT TI, FRACTURED AT HEX. FAILURE DATE IS (B)(6) 2025. THE IMPLANT IS NOT LOADABLE. THE HEX IS STILL IN THERE.
Patient problems: Failure of Implant
MAUDE report 23015903 ↗InjurySep 10, 2025Separation Failure; Separation Failure
IN THIS EVEN A S ATLANTIS ABUTMENT TI SCREW BROKE OFF AND BUCCAL WALL OF IMPLANT FRACTURED.
Patient problems: Failure of Implant
MAUDE report 23015790 ↗InjuryAug 27, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A S ATLANTIS ABUTMENT BECAME STUCK IN A DENTAL IMPLANT, RESULTING IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22903141 ↗InjuryAug 15, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT AN ATLANTIS ABUTMENT TI ABUTMENT HAS BENT SCREW. THE ABUTMENT IS STILL IN PATIENT'S MOUTH. THE IMPLANT IS NOT LOADABLE.
Patient problems: Failure of Implant
MAUDE report 22817305 ↗InjuryAug 15, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A S ATLANTIS ABUTMENT BECAME STUCK IN A DENTAL IMPLANT, RESULTING IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 22814006 ↗InjuryJul 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
IN THIS EVENT IT IS REPORTED THAT AN ATLANTIS ABUTMENT TI FRACTURED THAT RENDERED THE IMPLANT UNSALVAGEABLE. THE IMPLANT AND ABUTMENT WERE DISCARDED BY STAFF.
Patient problems: Failure of Implant
MAUDE report 22580096 ↗InjuryJun 12, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED ATLANTIS ABUTMENT TI HAD STRIPPED SCREW AT SITE #30. THE IMPLANT HAD TO BE REMOVED.
Patient problems: Failure of Implant
MAUDE report 22194528 ↗InjuryJun 5, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT A ATLANTIS ABUTMENT TI A DENTIST INFORMED ABOUT THE SCREW FRACTURED WHEN DELIVERING ATLANTIS ABUTMENT NEEDS A REPLACEMENT SCREW. IT IS INDICATING THAT FRACTURE SCREW WAS NOT REMOVED FROM IMPLANT. IMPLANT IS NOT LOADABLE. DOCTOR DECIDED TO LEAVE SCREW FRAGMENT INSIDE IMPLANT AND NOT LOAD IT. IMPLANT WAS NOT REMOVED. REOPENED CASE TO CHANGE IT FROM NON- SERIOUS TO SERIOUS.
Patient problems: Failure of Implant
MAUDE report 22148842 ↗InjuryJun 5, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT ATLANTIS ABUTMENT TI ABUTMENT LOOSENED CAUSING IMPLANT FAILURE.
Patient problems: Failure of Implant
MAUDE report 22148802 ↗InjuryMay 28, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO ABUTMENT FRACTURED.
Patient problems: Failure of Implant
MAUDE report 22097441 ↗InjuryMay 28, 2025Separation Failure; Separation Failure
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO ABUTMENT SCREW FRACTURE.
Patient problems: Failure of Implant
MAUDE report 22097343 ↗InjuryMay 20, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT ATLANTIS ABUTMENT TI - THE ABUTMENT FRACTURED. THE IMPLANT THAT WILL BE REMOVED DUE FAILURE (INFECTION AND PT HAS COMPROMISED HEALTH) GP/SURGEON DECIDED TO REMOVE COMPLETE IMPLANT. THE SCREW IS ALSO STILL INSIDE OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22056903 ↗InjuryMay 20, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT A ATLANTIS ABUTMENT TI - ABUTMENT FRACTURED LEADING TO IMPLANT REMOVAL. THE SCREW BROKE, NEEDED TO BE REMOVED.
Patient problems: Failure of Implant
MAUDE report 22056883 ↗InjuryMay 20, 2025Fracture; Fracture
IN THIS EVENT IT IS REPORTED THAT AN ATLANTIS ABUTMENT TI - ATLANTIS - 36 FRACTURE OF ABUTMENT, FRAGMENT COULDN'T BE REMOVED YET. SALES REP (B)(6) WOULD SET AN APPOINTMENT FOR RESCUE DOC. WITH RES07902- IMPLANT SEEMS TO BE LOADABLE. RECEIVED INFORMATION DIRECTLY FROM PATIENT THAT THE FRAGMENT COULDN'T BE REMOVED. THE SUGGESTION OF THE RESCUE DOC WAS TO REMOVE THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 22056593 ↗InjuryMay 15, 2025Failure to Osseointegrate; Failure to Osseointegrate
IN THIS EVENT IT IS REPORTED THAT A S ATLANTIS ABUTMENT TI IS BELIEVED TO CAUSED THE IMPLANT TO FRACTURE BECAUSE THE ABUTMENT WAS ORDERED FOR AN ASTRA EV 5.4 IMPLANT, AND THE IMPLANT THAT IS IN THE PATIENT'S MOUTH IS A PRIMETAPER EV 5.4 WITH AN INTERNAL CONNECTION OF 4.8.
Patient problems: Failure of Implant
MAUDE report 22026181 ↗InjuryMay 6, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED S ATLANTIS ABUTMENT TI FRACTURED AND THE IMPLANT CROWN IS BROKE AND NON-RESTORABLE. IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21970680 ↗InjuryMay 6, 2025Separation Failure; Separation Failure
IN THIS EVENT IT IS REPORTED THAT A S ATLANTIS ABUTMENT TI CANNOT BE RETRIEVED FROM #5 IMPLANT.
Patient problems: Failure of Implant
MAUDE report 21970629 ↗
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, 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
- Legacy™ SMARTbase, Narrow, NE 8745-80NNEImplant Direct Sybron Manufacturing LLC · 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.