Axiom PX34080Recalls & reported problems
Etablissements Anthogyr · Axiom implant PX Ø3.4 x 8.0, Replacement of a missing tooth for placement of a dental restoration, not usable in the molar area, not recommended in D1 bone. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Anthogyr Axiom dental implant has 1,433 FDA adverse event reports, with 1,392 injuries, 41 malfunctions and no deaths. The reports mostly describe the implant not bonding with the bone or losing that bond, and some mention gum and bone inflammation around the implant, pain and infection. 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
- 1,458
- Deaths reported
- 0
- Injuries reported
- 1,417
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,458 adverse event reports that list this exact device (DI 03663394002509), received between Aug 3, 2017 and Sep 28, 2026 — classified as 1,417 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,115 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 Osseointegrate1,115
- Loss of Osseointegration315
- Adverse Event Without Identified Device or Use Problem24
- Fracture3
- Difficult to Insert2
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions846
- Fibrosis270
- Inadequate Osseointegration247
- Pain127
- Unspecified Infection79
- Inflammation63
- Swelling/ Edema56
- Hemorrhage/Blood Loss/Bleeding34
Recent adverse event reports
The 25 most recent of 1,458 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919239 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919209 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919192 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919118 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919076 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918999 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918995 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918978 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918923 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918922 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918920 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824597 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50737777 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: Numbness; Unspecified Infection
MAUDE report 50737758 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653309 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653307 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50653304 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Pain
MAUDE report 50653298 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653260 ↗InjuryAug 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 22. On (b)(6) 2026, non-osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. At the event the patient experienced: Peri-implantitis, Mobility and Numbness. No further patient complications were reported.
Patient problems: Fibrosis; Numbness; Unspecified Infection
MAUDE report 50503852 ↗InjuryAug 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in the patient's mouth. Details of surgery: Implant surface not completely covered with bone and Ridge augmentation. On (b)(6)2026, non-osseointegration was verified. Patient presented with bone type III. 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 50480463 ↗InjuryAug 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in FDI 35. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with fair oral hygiene. 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 50480451 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50414088 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50414087 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50414086 ↗
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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 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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