ANKYLOS® 31024120Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Regular /X Abutment GH1.5/A0 · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07392532217401), received between Jul 10, 2023 and May 26, 2026 — classified as 13 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture13
- Failure to Osseointegrate2
- Loss of Osseointegration1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Failure of Implant7
- Unspecified Infection2
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25295344 ↗InjuryApr 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT IMPLANT FRACTURE AND SUBSEQUENT ABUTMENT EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919524 ↗InjuryApr 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT IMPLANT FRACTURE AND SUBSEQUENT ABUTMENT EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919523 ↗InjuryApr 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT IMPLANT FRACTURE, OCCLUSAL OVERLOAD AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919522 ↗InjuryApr 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT IMPLANT FRACTURE AND SUBSEQUENT ABUTMENT EXPLANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24919521 ↗InjuryFeb 26, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS RESTORED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24454068 ↗MalfunctionDec 18, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT FRACTURE AND SUBSEQUENT IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 23846150 ↗InjuryDec 4, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS DUE TO ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714448 ↗MalfunctionDec 2, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23700902 ↗InjuryNov 18, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS AND UNSPECIFIED INFECTION.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 23590162 ↗InjuryNov 12, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE. CUSTOMER RECEIVED REPAIR TOOLS AND MANUAL. THERE IS NO FURTHER INFORMATION WHICH INDICATES THAT THE REPAIR ATTEMPT FAILED.
Patient problems: Failure of Implant
MAUDE report 20663848 ↗InjuryAug 23, 2024Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20047557 ↗InjuryAug 15, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. PER DOCTOR, ABUTMENT AND SCREW FRACTURED, IMPLANT NOT LOADABLE.
Patient problems: Failure of Implant
MAUDE report 19994279 ↗InjurySep 19, 2023Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 17774019 ↗InjuryJul 10, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 17287839 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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