NobelActive® 34134 (UDI 07332747160093)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 4.3x15mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive dental implant has 2,171 reports, with 2,121 listed as injuries and no deaths. Most describe the implant failing to osseointegrate, or losing its bond with the jawbone. Many reports also mention infection and pain. 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
- 2,192
- Deaths reported
- 0
- Injuries reported
- 2,142
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,192 adverse event reports that list this exact device (DI 07332747160093), received between Nov 1, 2021 and Sep 30, 2026 — classified as 2,142 injuries, 50 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,278 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 Osseointegrate1,278
- Loss of Osseointegration530
- Osseointegration Problem170
- Fracture52
- Adverse Event Without Identified Device or Use Problem48
- Patient Device Interaction Problem47
- Migration17
- Difficult to Insert12
Patient problems
- Failure of Implant1,384
- No Clinical Signs, Symptoms or Conditions562
- Unspecified Infection254
- Pain193
- Abscess28
- Implant Pain26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available23
- Numbness21
Recent adverse event reports
The 25 most recent of 2,192 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953365 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953364 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940616 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940615 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796329 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796328 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796051 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796049 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795885 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795883 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50678889 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: Abscess
MAUDE report 50678888 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50677755 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50677737 ↗InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 26, 2026Loss of Osseointegration
Patient problems: Abscess
MAUDE report 50463090 ↗InjuryAug 26, 2026Loss of Osseointegration
InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441338 ↗InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441335 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381668 ↗InjuryAug 21, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381636 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358622 ↗InjuryAug 20, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358102 ↗InjuryAug 20, 2026Failure to Osseointegrate
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.