Axiom OP34080Recalls & reported problems
Etablissements Anthogyr · AXIOM IMPLANT Ø3.4 x 8.0 Replacement of a missing tooth for placement of a dental restoration · Class 2 · Implant
Quick summary
This is the Axiom dental implant from Anthogyr, placed in the jawbone. The 1,618 reports mostly describe the implant failing to bond with the surrounding bone or losing that bond, and some mention pain, fibrous tissue around the implant, and infection. The records include no deaths, 1,502 injuries and 116 malfunctions, and 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
- 1,630
- Deaths reported
- 0
- Injuries reported
- 1,514
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,630 adverse event reports that list this exact device (DI 03663394000055), received between Oct 27, 2016 and Sep 28, 2026 — classified as 1,514 injuries, 116 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,232 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 Osseointegrate1,232
- Loss of Osseointegration379
- Adverse Event Without Identified Device or Use Problem12
- Fracture7
- Difficult to Insert6
- Difficult to Remove2
Patient problems
- No Clinical Signs, Symptoms or Conditions878
- Inadequate Osseointegration383
- Fibrosis229
- Pain125
- Unspecified Infection101
- Inflammation74
- Swelling/ Edema62
- Hemorrhage/Blood Loss/Bleeding39
Recent adverse event reports
The 25 most recent of 1,630 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 50919243 ↗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 50758240 ↗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 50758212 ↗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 50758190 ↗InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758173 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50758143 ↗InjurySep 10, 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 50718865 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653341 ↗InjurySep 7, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653319 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653264 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653256 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fistula; Inflammation; Unspecified Infection
MAUDE report 50413980 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50413974 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50413970 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50413936 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413935 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50413933 ↗InjuryAug 24, 2026Loss of Osseointegration
Patient problems: Fibrosis; Swelling/ Edema; Unspecified Infection
MAUDE report 50413929 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413781 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted on (b)(6)2026 in FDI 24. Details of surgery: Implant surface not completely covered with bone. On (b)(6)2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Inflammation. No further patient complications were reported.
Patient problems: Inflammation
MAUDE report 50281681 ↗InjuryAug 17, 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 50281656 ↗InjuryAug 17, 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 50281655 ↗InjuryAug 17, 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 50281653 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted 2018 (b)(6) in FDI 35. On 2026 (b)(6), 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 50197539 ↗InjuryAug 10, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 41. Details of surgery: Implant surface not completely covered with bone. On 2026 (b)(6), non-osseointegration was verified. Patient presented with bone type III and poor oral hygiene. 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 50197525 ↗
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- 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.