NobelActive® 34140 (UDI 07332747160130)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 5.0x15mm · Class 2 · Implant
All models of NobelActive (56)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive implant is a root-form implant that is anchored in bone. Its 417 reports mostly describe the implant failing to bond with the bone, and some mention a lack of stability during placement. The reports include no deaths and 405 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
- 418
- Deaths reported
- 0
- Injuries reported
- 406
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 418 adverse event reports that list this exact device (DI 07332747160130), received between Nov 8, 2021 and Aug 25, 2026 — classified as 406 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (253 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 Osseointegrate253
- Loss of Osseointegration87
- Osseointegration Problem40
- Migration11
- Adverse Event Without Identified Device or Use Problem9
- Patient Device Interaction Problem8
- Device Markings/Labelling Problem3
- Activation, Positioning or Separation Problem2
Patient problems
- Failure of Implant244
- No Clinical Signs, Symptoms or Conditions132
- Unspecified Infection39
- Pain22
- Inflammation7
- Numbness6
- Foreign Body In Patient5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 418 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441314 ↗InjuryAug 25, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441306 ↗InjuryAug 20, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358260 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332965 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332964 ↗InjuryAug 11, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215525 ↗InjuryAug 11, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215524 ↗InjuryJul 28, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063121 ↗InjuryJul 28, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50063117 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805327 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805323 ↗InjuryJul 8, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754572 ↗InjuryJul 8, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754528 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698295 ↗InjuryJul 2, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698292 ↗InjuryJun 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629821 ↗InjuryJun 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629804 ↗InjuryJun 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25554421 ↗InjuryJun 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25554419 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538942 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538937 ↗InjuryJun 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525789 ↗InjuryJun 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525788 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525462 ↗InjuryJun 16, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25525458 ↗
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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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