ANKYLOS® 31021630Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Balance Posterior C/ 1.5 straight · 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
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07392532215865), received between May 24, 2024 and Sep 11, 2026 — classified as 10 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (10 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
- Fracture10
- Failure to Osseointegrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Failure of Implant3
- Inadequate Osseointegration1
- Inflammation1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss due to infection.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50731400 ↗InjuryApr 15, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE DUE TO OCCLUSAL OVERLOAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887836 ↗MalfunctionApr 13, 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 24853480 ↗InjuryJan 20, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Insufficient Information
MAUDE report 24116556 ↗InjuryJan 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111987 ↗InjuryJan 19, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE. THE DENTAL IMPLANT WAS EXPLANTED AS A RESULT.
Patient problems: Failure of Implant
MAUDE report 24107990 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24073103 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072761 ↗InjuryJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24072752 ↗InjuryJul 1, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 19642196 ↗InjuryMay 24, 2024Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant; Inflammation
MAUDE report 19390639 ↗
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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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