NobelActive® 34137 (UDI 07332747010664)Recalls & reported problems
Nobel Biocare AB · NobelActive® Internal RP 5.0x10mm · Class 2 · Implant
Quick summary
This NobelActive dental implant is a root-form implant placed in the jawbone. Its 3,378 reports mostly describe the implant failing to fuse with the jawbone, with patients reporting implant failure, pain and infection. The reports include no deaths and 3,364 injuries. No recalls name this device. Reports were lower in the most recent year (156) than in the year before (212).
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
- 3,385
- Deaths reported
- 0
- Injuries reported
- 3,371
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,385 adverse event reports that list this exact device (DI 07332747010664), received between Sep 10, 2019 and Sep 19, 2026 — classified as 3,371 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Loss of Osseointegration” (2,000 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 Osseointegration2,000
- Failure to Osseointegrate976
- Fracture192
- Osseointegration Problem126
- Adverse Event Without Identified Device or Use Problem54
- Insufficient Device Problem Information10
- Material Deformation5
- Device Damaged by Another Device4
Patient problems
- Failure of Implant3,079
- Pain664
- Unspecified Infection414
- No Clinical Signs, Symptoms or Conditions198
- Numbness63
- Abscess35
- Inflammation14
- Implant Pain10
Recent adverse event reports
The 25 most recent of 3,385 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833481 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833477 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811350 ↗InjurySep 17, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811344 ↗InjurySep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700906 ↗InjurySep 9, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700903 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700728 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700727 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50678841 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50678840 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463497 ↗InjuryAug 26, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463495 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50358336 ↗InjuryAug 19, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333128 ↗InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 19, 2026Loss of Osseointegration
InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50268149 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50267848 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266439 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264978 ↗InjuryAug 3, 2026Fracture
InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110875 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50110873 ↗InjuryJul 14, 2026Loss of Osseointegration
InjuryJul 14, 2026Loss of Osseointegration
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.