AXIOM® XT40080Recalls & reported problems
Etablissements Anthogyr · AXIOM IMPLANT X3 Ø4.0 X 8.0 · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Anthogyr Axiom XT dental implant appears in 880 adverse event reports, with 880 injuries and no deaths. Most describe the implant failing to bond with the surrounding bone, and some mention pain and swelling around the implant. 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
- 895
- Deaths reported
- 0
- Injuries reported
- 895
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 895 adverse event reports that list this exact device (DI 03663394483544), received between Dec 22, 2023 and Sep 28, 2026 — classified as 895 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (698 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
- Failure to Osseointegrate698
- Loss of Osseointegration176
- Adverse Event Without Identified Device or Use Problem19
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions589
- Fibrosis231
- Pain107
- Unspecified Infection44
- Inflammation37
- Swelling/ Edema37
- Hemorrhage/Blood Loss/Bleeding20
- Hypersensitivity/Allergic reaction12
Recent adverse event reports
The 25 most recent of 895 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in the patient's mouth. On 2026-08-12, non-osseointegration was verified. Patient presented with bone type IV. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919276 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919273 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919244 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918984 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918981 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918977 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50758210 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. Details of surgery: Primary stability not achieved. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758161 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6)2024 in FDI 24. On (b)(6)2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758150 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50758123 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758120 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. On (b)(6)2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758102 ↗InjurySep 14, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 16. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758097 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in the patient's mouth. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758092 ↗InjurySep 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. On (b)(6)2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758090 ↗InjurySep 11, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 26. On (b)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. There were no reported patient injuries or complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737788 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653362 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653348 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50653332 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50653322 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50653316 ↗InjurySep 7, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653311 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414102 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413988 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50413914 ↗
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- 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 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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