ANKYLOS® 31021640Recalls & reported problems
Dentsply Implants Manufacturing GmbH · Balance Posterior C/ 3.0 straight · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Dentsply Ankylos dental implant is a root-form endosseous implant used with a posterior abutment. The 28 reports mostly describe broken abutments, screws and cones, and parts that could not be unscrewed, sometimes requiring removal of the implant; 19 reports involved injuries and no deaths were reported. No recalls name this device. Reports rose sharply, from 1 in the previous 12 months to 25 in the most recent 12 months.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07392532215872), received between Aug 18, 2023 and Sep 9, 2026 — classified as 19 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (26 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
- Fracture26
- Failure to Osseointegrate1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Failure of Implant6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Inadequate Osseointegration1
- Osteolysis1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 50698697 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50058716 ↗MalfunctionJun 9, 2026Fracture
IT WAS REPORTED THAT THERE WAS AN ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446978 ↗InjuryMay 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209352 ↗MalfunctionMay 14, 2026Mechanical Problem
IT WAS REPORTED THAT A TOOL MALFUNCTION OCCURRED: THE INTERNAL HEXAGON OF THE ABUTMENT SCREW WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177184 ↗InjuryMay 5, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF A DENTAL ABUTMENT SCREW CONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25080220 ↗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 24887908 ↗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 24887668 ↗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 24853486 ↗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 24853471 ↗InjuryFeb 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24469523 ↗InjuryJan 28, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202174 ↗InjuryJan 28, 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 24200986 ↗InjuryJan 27, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT FRACTURE AND THE IMPLANT WAS REMOVED.
Patient problems: Failure of Implant
MAUDE report 24193897 ↗InjuryJan 20, 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 24118033 ↗InjuryJan 20, 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 24118013 ↗InjuryJan 20, 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 24117989 ↗InjuryJan 20, 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 24117656 ↗InjuryJan 20, 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 24115660 ↗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 24108013 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT IMPLANT AND A DENTAL LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064551 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT IMPLANT AND A DENTAL LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064549 ↗MalfunctionJan 14, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE ABUTMENT IMPLANT AND A DENTAL LOSS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24064548 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857697 ↗MalfunctionDec 19, 2025Fracture; Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A FRACTURE OF ABUTMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857657 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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