ANKYLOS® 31022530Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Balance Base Abutment C/ narrow GH1.5 · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07392532216565), received between Dec 8, 2023 and Aug 14, 2026 — classified as 11 injuries.
The most frequently reported specific device problem is “Fracture” (11 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
- Fracture11
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Failure of Implant3
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjuryAug 14, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50257840 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364106 ↗InjuryMay 7, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED DENTAL ABUTMENT BREAKAGE. THE ABUTMENT FRACTURED AT POSITION 15. THE IMPLANT REMAINS LOADABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25117280 ↗InjuryApr 7, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE. THE IMPLANT CAN STILL BE LOADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800488 ↗InjuryApr 7, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE RESULTING FRAGMENT LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 24800231 ↗InjuryJan 21, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24128797 ↗InjuryJan 20, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT SCREW FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24116212 ↗InjuryDec 23, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23875584 ↗InjuryDec 22, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23872390 ↗InjuryApr 2, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19019499 ↗InjuryDec 8, 2023Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 18293743 ↗
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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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