NobelActive® 34125 (UDI 07332747160024)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive dental implant has 11,833 adverse event reports, including 11,724 injuries and no deaths. Most describe the implant failing to bond with the jawbone, and patients report implant failure, infection, pain, abscesses or numbness. A few reports describe fractures. 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
- 11,993
- Deaths reported
- 0
- Injuries reported
- 11,884
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11,993 adverse event reports that list this exact device (DI 07332747160024), received between Oct 29, 2021 and Sep 30, 2026 — classified as 11,884 injuries, 109 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8,084 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 Osseointegrate8,084
- Loss of Osseointegration2,417
- Osseointegration Problem781
- Adverse Event Without Identified Device or Use Problem217
- Fracture186
- Patient Device Interaction Problem76
- Migration55
- Premature Separation38
Patient problems
- Failure of Implant7,613
- No Clinical Signs, Symptoms or Conditions3,472
- Pain879
- Unspecified Infection858
- Numbness170
- Abscess140
- Implant Pain120
- Inflammation117
Recent adverse event reports
The 25 most recent of 11,993 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954426 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954413 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Implant Pain
MAUDE report 50953082 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Implant Pain
MAUDE report 50953081 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940326 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940321 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940172 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940171 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939922 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939919 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925436 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925435 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925420 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925419 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925400 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925399 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925264 ↗InjurySep 28, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50925263 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833515 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833513 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833451 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833447 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833406 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833393 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833382 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.