Axiom OP28120Recalls & reported problems
Etablissements Anthogyr · Implant Ø2.8 x 12 mm Replacement of a missing tooth for placement of a dental restoration · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Anthogyr Axiom dental implant is placed in the jawbone to support a replacement tooth. The 281 reports mostly describe implants that did not fuse with the bone, and a few describe fractures. The reports include 278 injuries and no deaths. 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
- 283
- Deaths reported
- 0
- Injuries reported
- 280
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 283 adverse event reports that list this exact device (DI 03663394000031), received between Sep 29, 2017 and Sep 17, 2026 — classified as 280 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (263 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 Osseointegrate263
- Loss of Osseointegration18
- Fracture5
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- No Clinical Signs, Symptoms or Conditions228
- Fibrosis20
- Inadequate Osseointegration18
- Pain14
- Inflammation13
- Swelling/ Edema8
- Unspecified Infection6
- Hypersensitivity/Allergic reaction3
Recent adverse event reports
The 25 most recent of 283 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806563 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806561 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653300 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50653268 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 32. 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 50281642 ↗InjuryAug 17, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026 (b)(6) in FDI 32. 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 50281527 ↗InjuryAug 13, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50238224 ↗InjuryJul 27, 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 50039985 ↗InjuryJun 29, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 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 25655289 ↗InjuryJun 29, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 14. 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 25655216 ↗InjuryJun 4, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 23. 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 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 25395475 ↗InjuryMay 26, 2026Loss of Osseointegration
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN FDI 12. 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 25281729 ↗InjuryApr 27, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 41. 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 25003434 ↗InjuryApr 27, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2025 IN FDI 35. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6)2025, 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 25003346 ↗InjuryApr 16, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 32. 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 24897720 ↗InjuryApr 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6)2025 IN FDI 31. 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 24833400 ↗InjuryApr 9, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 41. 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 24833309 ↗InjuryApr 2, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2026 IN FDI 12. 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 24768039 ↗InjuryMar 30, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 41. 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 24734081 ↗InjuryMar 30, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 12. 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 24732262 ↗InjuryMar 30, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 41. 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 24731161 ↗InjuryMar 26, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 31. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III AND FAIR 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 24702877 ↗InjuryFeb 27, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 12. ON (B)(6) 2025, 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 24472840 ↗InjuryFeb 26, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN FDI 41. ON (B)(6) 2025, 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 24458435 ↗InjuryFeb 12, 2026Failure to Osseointegrate
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN FDI 33. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, 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 24325138 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
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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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