NobelActive® 35215 (UDI 07332747017922)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal NP 3.5x18mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive dental implant has 205 adverse event reports: no deaths and 203 injuries. Most reports describe the implant failing to bond with the jawbone, and some mention infection or pain around the implant. 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
- 205
- Deaths reported
- 0
- Injuries reported
- 203
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 07332747017922), received between Sep 11, 2019 and Jun 17, 2026 — classified as 203 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (87 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
- Loss of Osseointegration87
- Failure to Osseointegrate85
- Osseointegration Problem17
- Adverse Event Without Identified Device or Use Problem6
- Fracture4
- Insufficient Device Problem Information2
- Patient Device Interaction Problem2
- Device Fell1
Patient problems
- Failure of Implant183
- Unspecified Infection33
- Pain26
- No Clinical Signs, Symptoms or Conditions14
- Abscess2
- Implant Pain2
- Insufficient Information2
- Numbness2
Recent adverse event reports
The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538867 ↗InjuryJun 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538866 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248951 ↗InjuryMay 21, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25248948 ↗InjuryFeb 16, 2026Failure to Osseointegrate
InjuryFeb 16, 2026Failure to Osseointegrate
InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692151 ↗InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692150 ↗InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692127 ↗InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22692111 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22624581 ↗InjuryJul 28, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22624471 ↗InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJul 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22489525 ↗InjuryJul 12, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22489524 ↗InjuryMar 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 4, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 10, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2025Failure to Osseointegrate; Failure to Osseointegrate
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.