Axiom PX46100Recalls & reported problems
Etablissements Anthogyr · Axiom implant PX Ø4.6 x 10.0, 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
Quick summary
This Axiom dental implant is a root-form implant placed in the jawbone to hold a replacement tooth. Its 3,240 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting scar tissue, pain and swelling. The reports include no deaths and 3,218 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
- 3,288
- Deaths reported
- 0
- Injuries reported
- 3,266
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,288 adverse event reports that list this exact device (DI 03663394000352), received between Sep 22, 2017 and Sep 30, 2026 — classified as 3,266 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (2,924 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 Osseointegrate2,924
- Loss of Osseointegration327
- Adverse Event Without Identified Device or Use Problem32
- Fracture19
- Separation Failure4
- Difficult to Insert1
Patient problems
- No Clinical Signs, Symptoms or Conditions2,321
- Fibrosis427
- Pain275
- Inadequate Osseointegration256
- Swelling/ Edema170
- Unspecified Infection163
- Inflammation162
- Hemorrhage/Blood Loss/Bleeding61
Recent adverse event reports
The 25 most recent of 3,288 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 26. On 2026(b)(6), non-osseointegration was verified. Patient presented with fair oral hygiene. 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 50950167 ↗InjurySep 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2025(b)(6) in FDI 46. On 2026(b)(6) non-osseointegration was verified. Patient presented with bone type III and fair oral hygiene. 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 50950164 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919257 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919256 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Inflammation; Unspecified Infection
MAUDE report 50919248 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919217 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919211 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919201 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919200 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 16. 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 50919195 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919167 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919153 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919148 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919139 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919133 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919131 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919130 ↗InjurySep 28, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 24. On 2026-06-26, 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 50919122 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919102 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919090 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919087 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919082 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919067 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919054 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919047 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.