Axiom PX34140Recalls & reported problems
Etablissements Anthogyr · Axiom implant PX Ø3.4 x 14.0, 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 implant has 429 adverse event reports, with 411 injuries and no deaths. The reports mostly describe the implant failing to bond with the bone or losing that bond, and some mention scar tissue, 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
- 436
- Deaths reported
- 0
- Injuries reported
- 418
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 03663394002530), received between Aug 4, 2017 and Sep 28, 2026 — classified as 418 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (362 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 Osseointegrate362
- Loss of Osseointegration61
- Adverse Event Without Identified Device or Use Problem13
- Difficult to Insert1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions249
- Inadequate Osseointegration91
- Fibrosis60
- Unspecified Infection25
- Pain23
- Inflammation20
- Swelling/ Edema17
- Hypersensitivity/Allergic reaction6
Recent adverse event reports
The 25 most recent of 436 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918993 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918960 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737832 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653365 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653364 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653263 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413968 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 11. On 2026(b)(6), 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 50258441 ↗InjuryAug 14, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 21. On 2026(b)(6), 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 50258439 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238235 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in ADA 16. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. No product was returned to the manufacturer. There were no patient operative or post-operative complications reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50197666 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 22. On (b)(6) 2026, loss of osseointegration was verified. Patient presented with bone type III. The device was forwarded to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50118643 ↗InjuryJul 31, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2016 in FDI 32. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Mobility, Increased Sensitivity and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Hyperresponsive to stimuli; Inflammation; Unspecified Infection
MAUDE report 50102443 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 13. On 2026(b)(6), 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 50087848 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2026 in FDI 14. Details of surgery: Primary stability not achieved and Implant surface not completely covered with bone. On (b)(6)2026, 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 50087837 ↗InjuryJun 19, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 13. 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 25564492 ↗InjuryJun 19, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 34. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: PERI-IMPLANTITIS, PAIN, MOBILITY, SWELLING, BLEEDING, ABSCESS AND INFLAMMATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Abscess; Fibrosis; Hemorrhage/Blood Loss/Bleeding; Inflammation; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25564488 ↗InjuryJun 19, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 46. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2026, 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 25564455 ↗InjuryJun 18, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 25. ON (B)(6) 2026, 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 25550257 ↗InjuryJun 18, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 41. ON (B)(6) 2026, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: SWELLING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Swelling/ Edema
MAUDE report 25550152 ↗InjuryJun 11, 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 25474748 ↗InjuryJun 4, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 11. 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 25395495 ↗InjuryJun 3, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2023 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, 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 25377852 ↗InjuryJun 3, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN THE PATIENT'S MOUTH. ON (B)(6) 2025, 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 25377846 ↗InjuryMay 26, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN FDI 13. ON (B)(6) 2026, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III. 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 25281677 ↗
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 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.
How reports and recalls are matched · Editorial policy · Report an error on this page