Axiom PX46060Recalls & reported problems
Etablissements Anthogyr · Axiom implant PX Ø4.6 x 6.5, 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 is a screw placed in the jaw bone to support a replacement tooth. Its 734 reports mostly describe the implant failing to fuse with the bone, and some also mention scar tissue, swelling or infection. The reports mention no deaths and 720 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
- 740
- Deaths reported
- 0
- Injuries reported
- 726
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 740 adverse event reports that list this exact device (DI 03663394001861), received between Oct 5, 2017 and Sep 28, 2026 — classified as 726 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (606 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 Osseointegrate606
- Loss of Osseointegration125
- Adverse Event Without Identified Device or Use Problem7
- Fracture7
- Difficult to Insert2
Patient problems
- No Clinical Signs, Symptoms or Conditions446
- Fibrosis134
- Inadequate Osseointegration99
- Pain79
- Swelling/ Edema38
- Unspecified Infection37
- Inflammation35
- Hyperresponsive to stimuli13
Recent adverse event reports
The 25 most recent of 740 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 50919203 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919199 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Inflammation
MAUDE report 50919037 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824621 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Fibrosis
MAUDE report 50758209 ↗InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737756 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis; Pain
MAUDE report 50653296 ↗InjurySep 7, 2026Failure to Osseointegrate
Patient problems: Fibrosis
MAUDE report 50653286 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50414119 ↗InjuryAug 24, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2021 in FDI 26. Details of surgery: Implant surface not completely covered with bone. On (b)(6) 2026, 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 50413790 ↗InjuryAug 24, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50413758 ↗InjuryAug 24, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2026 in FDI 46. 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 50413753 ↗InjuryAug 17, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2024 in the patient's mouth. On (b)(6) 2026, 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 50281552 ↗InjuryAug 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50281533 ↗InjuryAug 13, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2025 in FDI 17. 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 50238223 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted on (b)(6)2025 in ADA 27. On (b)(6)2026, loss of osseointegration was verified. No product was returned to the manufacturer. At the event the patient experienced: Mobility. No further patient complications were reported.
Patient problems: Fibrosis
MAUDE report 50197667 ↗InjuryAug 10, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2023 in FDI 23. 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: Peri-implantitis, Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Unspecified Infection
MAUDE report 50197659 ↗InjuryAug 3, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 36. On (b)(6) 2026, loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Pain and Mobility. No further patient complications were reported.
Patient problems: Fibrosis; Pain
MAUDE report 50118696 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in ADA 10. On (B)(6) 2026, non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Increased Sensitivity. No further patient complications were reported.
Patient problems: Hyperresponsive to stimuli
MAUDE report 50118620 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (B)(6) 2026 in FDI 47. 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 50118579 ↗InjuryAug 3, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6) 2025 in FDI 36. 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 50118502 ↗InjuryJul 30, 2026Failure to Osseointegrate
The clinician reports the implant was inserted (b)(6)2026 in FDI 16. Details of surgery: Sinus augmentation. On (b)(6) 2026, non-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 50087788 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (b)(6) 2026 in FDI 35. Details of surgery: Primary stability not achieved. On (b)(6) 2026, loss of 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: Pain, Mobility and Swelling. No further patient complications were reported.
Patient problems: Fibrosis; Pain; Swelling/ Edema
MAUDE report 50040091 ↗InjuryJul 27, 2026Loss of Osseointegration
The clinician reports the implant was inserted (B)(6) 2025 in FDI 45. On (B)(6) 2026 loss of osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis. No further patient complications were reported.
Patient problems: Unspecified Infection
MAUDE report 50022864 ↗InjuryJul 27, 2026Failure to Osseointegrate
The clinician reports the implant was inserted 2026(b)(6) in FDI 46. On 2026(b)(6), non-osseointegration was verified. The device was forwarded to the manufacturer. At the event the patient experienced: Peri-implantitis, Pain, Mobility and Inflammation. No further patient complications were reported.
Patient problems: Fibrosis; Inflammation; Pain; Unspecified Infection
MAUDE report 50022862 ↗
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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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