ANKYLOS® 31024132Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Regular /X Abutment GH3.0/A15 · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07392532217470), received between Oct 14, 2024 and Sep 29, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (5 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
- Fracture5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Fracture
It was reported that a dental screw fracture occurred during the laboratory process when the thread came off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932504 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058822 ↗MalfunctionApr 7, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT IMPLANT FRACTURE, AN UNSPECIFIED INFECTION, IMPLANT MOBILITY ISSUES AND A SUBSEQUENT DENTAL IMPLANT LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 24796405 ↗InjuryFeb 6, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24276917 ↗InjuryOct 14, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20438934 ↗
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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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