NobelActive® 34128 (UDI 07332747160055)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x15mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive dental implant is a screw placed in the jawbone to hold a replacement tooth. Most reports describe implants that failed to bond with the bone, and some mention infection, abscess or pain. The records include 1,940 reports and 1,894 injuries, with no deaths, 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
- 1,943
- Deaths reported
- 0
- Injuries reported
- 1,897
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,943 adverse event reports that list this exact device (DI 07332747160055), received between Oct 29, 2021 and Sep 29, 2026 — classified as 1,897 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,207 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 Osseointegrate1,207
- Loss of Osseointegration397
- Osseointegration Problem155
- Fracture59
- Adverse Event Without Identified Device or Use Problem41
- Patient Device Interaction Problem34
- Migration19
- Difficult to Insert8
Patient problems
- Failure of Implant1,176
- No Clinical Signs, Symptoms or Conditions589
- Unspecified Infection183
- Pain122
- Abscess23
- Inflammation22
- Numbness15
- Implant Pain14
Recent adverse event reports
The 25 most recent of 1,943 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939589 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939586 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830044 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830043 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811680 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811679 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742805 ↗InjurySep 11, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742804 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699812 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50699808 ↗InjuryAug 25, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441320 ↗InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441319 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358623 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358621 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358025 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332472 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50332470 ↗InjuryAug 18, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310313 ↗InjuryAug 18, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310312 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243100 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243099 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228199 ↗InjuryAug 12, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228196 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187899 ↗InjuryAug 8, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50187892 ↗
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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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.