ANKYLOS® 31010405Recalls & reported problems
Dentsply Implants Manufacturing GmbH · C/X Implant A8 Ø3.5/L8 · Class 2 · Implant
All models of ANKYLOS (112)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ANKYLOS implant is a root-form dental implant placed in bone. Its 2,884 adverse event reports mostly describe implants that fail to fuse with the bone or later lose that bond, and some mention fractures. Infection, inflammation and bone loss around the implant are also mentioned. The reports include no deaths and 2,883 injuries. No recalls name this device.
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
- 2,916
- Deaths reported
- 0
- Injuries reported
- 2,915
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,916 adverse event reports that list this exact device (DI 07392532205941), received between Jun 16, 2023 and Sep 30, 2026 — classified as 2,915 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,822 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
- Failure to Osseointegrate1,822
- Loss of Osseointegration1,007
- Fracture87
- Damaged Thread3
- Separation Failure3
- Off-Label Use2
- Crack1
- Material Deformation1
Patient problems
- Failure of Implant2,876
- Unspecified Infection450
- Inflammation433
- Osteolysis258
- Pocket Erosion156
- Inadequate Osseointegration21
- No Clinical Signs, Symptoms or Conditions16
- Implant Pain13
Recent adverse event reports
The 25 most recent of 2,916 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953409 ↗InjurySep 30, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50947560 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: Osteolysis
MAUDE report 50938875 ↗InjurySep 29, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50933678 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50915201 ↗InjurySep 28, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50915142 ↗InjurySep 28, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913050 ↗InjurySep 21, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835062 ↗InjurySep 20, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834752 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832459 ↗InjurySep 18, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50819560 ↗InjurySep 17, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50807781 ↗InjurySep 17, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50803216 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50796501 ↗InjurySep 16, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790679 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50779728 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: Inadequate Osseointegration
MAUDE report 50775274 ↗InjurySep 15, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50775057 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773586 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50773109 ↗InjurySep 15, 2026Failure to Osseointegrate
It was reported that a patient experienced a dental implant loss.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772504 ↗InjurySep 15, 2026Loss of Osseointegration
It was reported that a patient experienced a dental implant loss. There was no reported injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770484 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50764547 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50764439 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Inadequate Osseointegration
MAUDE report 50764287 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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